Ignite Creation Date:
2025-12-25 @ 12:10 AM
Ignite Modification Date:
2026-02-27 @ 12:48 AM
Study NCT ID:
NCT01702558
Status:
TERMINATED
Last Update Posted:
2021-01-22
First Post:
2012-10-04
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Combination Study of Kadcyla (Trastuzumab Emtansine) and Capecitabine in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Metastatic Breast Cancer (mBC) or HER2-Positive Locally Advanced/Metastatic Gastric Cancer (LA/mGC)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Lebanon', 'Peru']}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D013274', 'term': 'Stomach Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D013272', 'term': 'Stomach Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069287', 'term': 'Capecitabine'}, {'id': 'D000080044', 'term': 'Ado-Trastuzumab Emtansine'}], 'ancestors': [{'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D005472', 'term': 'Fluorouracil'}, {'id': 'D014498', 'term': 'Uracil'}, {'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D003853', 'term': 'Deoxyribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D008453', 'term': 'Maytansine'}, {'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D047029', 'term': 'Lactams, Macrocyclic'}, {'id': 'D047028', 'term': 'Macrocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D000068878', 'term': 'Trastuzumab'}, {'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'genentech@druginfo.com', 'phone': '800 821-8590', 'title': 'Medical Communications', 'organization': 'Hoffmann-La Roche'}, 'certainAgreement': {'otherDetails': "The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'The sponsor decided to terminate the study after 70% of participants had experienced a PFS event. Participants were allowed to continue treatment by enrolling into study NCT00781612 or by moving to commercial drug, depending on their country.'}}, 'adverseEventsModule': {'timeFrame': 'Phase 1: Baseline up to 42 days after last dose (up to approximately 1.5 years overall); Phase 2: Baseline up to 42 days after last dose (up to approximately 2.5 years overall)', 'description': 'Safety population included all participants who received \\>/=1 dose of study drug. Participants were analyzed as per actual treatment received. In Phase 2, out of 161 participants, 1 participant was randomized in error (did not receive any treatment) and was excluded from safety analysis and 1 participant who was randomized to T-DM1 alone Arm received Capecitabine throughout study and was counted in T-DM1+Cape Arm.', 'eventGroups': [{'id': 'EG000', 'title': 'Phase 1 (mBC) Cohort 1 (DL 1): T-DM1 + Cape', 'description': 'In Phase 1, Cohort 1 participants (with mBC) received trastuzumab emtansine at a dose of 3.6 mg/kg via IV infusion (on Day 1 \\[on Day 2 for Cycle 1\\] of each 21-day cycle) along with capecitabine at a dose level of 750 mg/m\\^2 via tablet orally twice daily on Days 1-14 of each 21-day cycle until unacceptable toxicity, withdrawal of consent, PD, death, reasons deemed by the treating physician, or study termination by the sponsor.', 'otherNumAtRisk': 7, 'deathsNumAtRisk': 7, 'otherNumAffected': 7, 'seriousNumAtRisk': 7, 'deathsNumAffected': 4, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Phase 1 (mBC) Cohort 1 (DL -1): T-DM1 + Cape', 'description': 'In Phase 1, Cohort 1 participants (with mBC) received trastuzumab emtansine at a dose of 3.6 mg/kg via IV infusion (on Day 1 \\[on Day 2 for Cycle 1\\] of each 21-day cycle) along with capecitabine at a dose level of 700 mg/m\\^2 via tablet orally twice daily on Days 1-14 of each 21-day cycle until unacceptable toxicity, withdrawal of consent, PD, death, reasons deemed by the treating physician, or study termination by the sponsor.', 'otherNumAtRisk': 5, 'deathsNumAtRisk': 5, 'otherNumAffected': 5, 'seriousNumAtRisk': 5, 'deathsNumAffected': 3, 'seriousNumAffected': 2}, {'id': 'EG002', 'title': 'Phase 1 (LA/mGC) Cohort 2 (DL -1): T-DM1 + Cape', 'description': 'In Phase 1, Cohort 2 participants (with LA/mGC) received trastuzumab emtansine at a dose of 2.4 mg/kg via IV infusion on Day 1 (Day 2 of first week) of every week along with capecitabine at a dose level of 700 mg/m\\^2 via tablet orally twice daily on Days 1-14 followed by a 7-day rest period, in each 21-day cycle until unacceptable toxicity, withdrawal of consent, PD, death, reasons deemed by the treating physician, or study termination by the sponsor.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 6, 'seriousNumAtRisk': 6, 'deathsNumAffected': 3, 'seriousNumAffected': 4}, {'id': 'EG003', 'title': 'Phase 2 (mBC): T-DM1 + Cape', 'description': 'In Phase 2, participants (with mBC) who were randomized to this group received trastuzumab emtansine at a dose of 3.6 mg/kg via IV infusion on Day 1 of each 21-day cycle along with capecitabine at a dose level of 700 mg/m\\^2 via tablet orally twice daily on Days 1-14 of each 21-day cycle until unacceptable toxicity, withdrawal of consent, PD, death, reasons deemed by the treating physician, or study termination by the sponsor.', 'otherNumAtRisk': 82, 'deathsNumAtRisk': 82, 'otherNumAffected': 75, 'seriousNumAtRisk': 82, 'deathsNumAffected': 18, 'seriousNumAffected': 11}, {'id': 'EG004', 'title': 'Phase 2 (mBC): T-DM1', 'description': 'In Phase 2, participants (with mBC) who were randomized to this group received trastuzumab emtansine at a dose of 3.6 mg/kg via IV infusion on Day 1 of each 21-day cycle until investigator-assessed PD, unacceptable toxicity, withdrawal of consent, death, reasons deemed by the treating physician, or study termination by the Sponsor.', 'otherNumAtRisk': 78, 'deathsNumAtRisk': 78, 'otherNumAffected': 64, 'seriousNumAtRisk': 78, 'deathsNumAffected': 21, 'seriousNumAffected': 10}], 'otherEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 82, 'numAffected': 27}, {'groupId': 'EG004', 'numAtRisk': 78, 'numAffected': 18}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 82, 'numAffected': 7}, {'groupId': 'EG004', 'numAtRisk': 78, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 82, 'numAffected': 8}, {'groupId': 'EG004', 'numAtRisk': 78, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.0'}, {'term': 'Gingival bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 82, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 78, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 82, 'numAffected': 16}, {'groupId': 'EG004', 'numAtRisk': 78, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 82, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 78, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.0'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 82, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 78, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.0'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 82, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 78, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.0'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 82, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 78, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 82, 'numAffected': 7}, {'groupId': 'EG004', 'numAtRisk': 78, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.0'}, {'term': 'Haematochezia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 82, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 78, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.0'}, {'term': 'Rectal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 82, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 78, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.0'}, {'term': 'Anal fissure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 82, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 78, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.0'}, {'term': 'Anal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 82, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 78, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.0'}, {'term': 'Chapped lips', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 82, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 78, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.0'}, {'term': 'Dental caries', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 82, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 78, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 82, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 78, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.0'}, {'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 82, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 78, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.0'}, {'term': 'Eructation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 82, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 78, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.0'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 82, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 78, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.0'}, {'term': 'Frequent bowel movements', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 82, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 78, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.0'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 82, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 78, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.0'}, {'term': 'Gingival pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 82, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 78, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.0'}, {'term': 'Glossodynia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 82, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 78, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.0'}, {'term': 'Haemorrhoidal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 82, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 78, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.0'}, {'term': 'Hypoaesthesia oral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 82, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 78, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 82, 'numAffected': 11}, {'groupId': 'EG004', 'numAtRisk': 78, 'numAffected': 9}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 82, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 78, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.0'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 82, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 78, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.0'}, {'term': 'Muscular weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 82, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 78, 'numAffected': 0}], 'organSystem': 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'numAtRisk': 82, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 78, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.0'}, {'term': 'Diabetes mellitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 82, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 78, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.0'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 82, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 78, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.0'}, {'term': 'Sciatica', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 82, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 78, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.0'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 82, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 78, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.0'}, {'term': 'Fracture displacement', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 82, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 78, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.0'}, {'term': 'Hepatic enzyme increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 82, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 78, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.0'}, {'term': 'Uterine polyp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 82, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 78, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Phase 1 (mBC): Percentage of Participants With Dose-Limiting Toxicities (DLTs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 1 (mBC) Cohort 1 (DL 1): T-DM1 + Cape', 'description': 'In Phase 1, Cohort 1 participants (with mBC) received trastuzumab emtansine at a dose of 3.6 mg/kg via IV infusion (on Day 1 \\[on Day 2 for Cycle 1\\] of each 21-day cycle) along with capecitabine at a dose level of 750 mg/m\\^2 via tablet orally twice daily on Days 1-14 of each 21-day cycle until unacceptable toxicity, withdrawal of consent, PD, death, reasons deemed by the treating physician, or study termination by the sponsor.'}, {'id': 'OG001', 'title': 'Phase 1 (mBC) Cohort 1 (DL -1): T-DM1 + Cape', 'description': 'In Phase 1, Cohort 1 participants (with mBC) received trastuzumab emtansine at a dose of 3.6 mg/kg via IV infusion (on Day 1 \\[on Day 2 for Cycle 1\\] of each 21-day cycle) along with capecitabine at a dose level of 700 mg/m\\^2 via tablet orally twice daily on Days 1-14 of each 21-day cycle until unacceptable toxicity, withdrawal of consent, PD, death, reasons deemed by the treating physician, or study termination by the sponsor.'}], 'classes': [{'categories': [{'measurements': [{'value': '33.3', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Continuously during Cycle 1 (up to 3 weeks)', 'description': 'A DLT was defined as any one of the following study treatment related toxicities: Uncomplicated Grade 4 thrombocytopenia that does not recover before Day 21; thrombocytopenia complicated with clinically significant bleeding requiring medical intervention; Grade 4 neutropenia lasting more than (\\>) 7 consecutive days; febrile neutropenia with absolute neutrophil count (ANC) less than (\\<) 1000 cells/millimeter cube (mm\\^3); Grade greater than or equal to (\\>/=) 3 diarrhea or Grade 3 hand-foot syndrome (in absence of dihydropyrimidine dehydrogenase \\[DPD\\] deficiency only for DL 1); any other Grade \\>/=3 toxicity prohibiting start of Cycle 2; Grade 2 toxicity requiring treatment interruption for \\>14 days (\\>7 days for DL 1); for DL -1 only: \\<14 full doses of capecitabine; Cycle 2 dose level \\<100 percent (%).', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on Phase 1 DLT-evaluable population for mBC cohort, which included all enrolled and treated mBC participants who did not experience any major protocol deviation and completed Cycle 1.'}, {'type': 'PRIMARY', 'title': 'Phase 1 (mBC): Maximum Tolerated Dose (MTD) of Capecitabine When Combined With Trastuzumab Emtansine (3.6 mg/kg Every 3 Weeks)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 1 (mBC) Cohort 1: T-DM1 + Cape', 'description': 'In Phase 1, Cohort 1 participants (with mBC) received trastuzumab emtansine at a dose of 3.6 mg/kg via IV infusion (on Day 1 \\[on Day 2 for Cycle 1\\] of each 21-day cycle) along with capecitabine at a dose level of 700 or 750 mg/m\\^2 via tablet orally twice daily on Days 1-14 of each 21-day cycle until unacceptable toxicity, withdrawal of consent, PD, death, reasons deemed by the treating physician, or study termination by the sponsor.'}], 'classes': [{'categories': [{'measurements': [{'value': '700', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Continuously during Cycle 1 (up to 3 weeks)', 'description': 'MTD was defined as the dose level for which the probability of DLT is equal to a protocol-specified target probability. A DLT was defined as any one of the following study treatment related toxicities: Uncomplicated Grade 4 thrombocytopenia that does not recover before Day 21; thrombocytopenia complicated with clinically significant bleeding requiring medical intervention; Grade 4 neutropenia lasting \\>7 consecutive days; febrile neutropenia with ANC \\<1000 cells/mm\\^3; Grade \\>/=3 diarrhea or Grade 3 hand-foot syndrome (in absence of DPD deficiency only for DL 1); any other Grade \\>/=3 toxicity prohibiting start of Cycle 2; Grade 2 toxicity requiring treatment interruption for \\>14 days (\\>7 days for DL 1); for DL -1 only: \\<14 full doses of capecitabine; Cycle 2 dose level \\<100%.', 'unitOfMeasure': 'mg/m^2', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on Phase 1 DLT-evaluable population for mBC cohort.'}, {'type': 'PRIMARY', 'title': 'Phase 2 (mBC): Percentage of Participants With Best Overall Response (BOR) as Assessed by the Investigator According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 2 (mBC): T-DM1 + Cape', 'description': 'In Phase 2, participants (with mBC) who were randomized to this group received trastuzumab emtansine at a dose of 3.6 mg/kg via IV infusion on Day 1 of each 21-day cycle along with capecitabine at a dose level of 700 mg/m\\^2 via tablet orally twice daily on Days 1-14 of each 21-day cycle until unacceptable toxicity, withdrawal of consent, PD, death, reasons deemed by the treating physician, or study termination by the sponsor.'}, {'id': 'OG001', 'title': 'Phase 2 (mBC): T-DM1', 'description': 'In Phase 2, participants (with mBC) who were randomized to this group received trastuzumab emtansine at a dose of 3.6 mg/kg via IV infusion on Day 1 of each 21-day cycle until investigator-assessed PD, unacceptable toxicity, withdrawal of consent, death, reasons deemed by the treating physician, or study termination by the Sponsor.'}], 'classes': [{'categories': [{'measurements': [{'value': '44.4', 'groupId': 'OG000', 'lowerLimit': '35.0', 'upperLimit': '54.2'}, {'value': '36.3', 'groupId': 'OG001', 'lowerLimit': '27.3', 'upperLimit': '46.0'}]}]}], 'analyses': [{'pValue': '0.336', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Response Rates', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '8.2', 'ciLowerLimit': '-4.5', 'ciUpperLimit': '20.9', 'estimateComment': '90% CI was estimated using Hauck-Anderson approach.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline until CR/PR, consent withdrawal, or study end whichever occurred first (up to approximately 2.5 years overall)', 'description': 'Tumor response was assessed by the investigator according to RECIST v1.1. BOR was defined as percentage of participants with a complete response (CR) or partial response (PR) that was confirmed by repeat assessments \\>/=4 weeks after initial documentation. CR was defined as the disappearance of all target lesions (TLs) and non-TLs; short axis (SA) reduction to \\<10 millimeters (mm) for nodal TLs/non-TLs; and no new lesions. PR was defined as \\>/=30% decrease in sum of diameters (SoD) of TLs, taking as reference the baseline SoD; no progression in non-TLs; and no new lesions. The 90% confidence Interval (CI) was computed using Clopper-Pearson approach.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on Intent-to-Treat (ITT) Population, which included all participants in the randomized Phase 2 part of the study. Participants were analyzed as per the initial randomization. Participants without tumor assessment after start of study treatment were considered as non-responders.'}, {'type': 'PRIMARY', 'title': 'Phase 1 (LA/mGC): Percentage of Participants With DLTs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 1 (LA/mGC) Cohort 2 (DL -1): T-DM1 + Cape', 'description': 'In Phase 1, Cohort 2 participants (with LA/mGC) received trastuzumab emtansine at a dose of 2.4 mg/kg via IV infusion on Day 1 (Day 2 of first week) of every week along with capecitabine at a dose level of 700 mg/m\\^2 via tablet orally twice daily on Days 1-14 followed by a 7-day rest period, in each 21-day cycle until unacceptable toxicity, withdrawal of consent, PD, death, reasons deemed by the treating physician, or study termination by the sponsor.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Continuously during 3 weeks', 'description': 'A DLT was defined as any one of the following study treatment related toxicities: Uncomplicated Grade 4 thrombocytopenia that does not recover before Day 21; thrombocytopenia complicated with clinically significant bleeding requiring medical intervention; Grade 4 neutropenia lasting \\>7 consecutive days; febrile neutropenia with ANC \\<1000 cells/mm\\^3; Grade \\>/=3 diarrhea or Grade 3 hand-foot syndrome; any other Grade \\>/=3 toxicity prohibiting start of Cycle 2; Grade 2 toxicity requiring treatment interruption for \\>14 days; \\<14 full doses of capecitabine; Cycle 2 dose level \\<100%.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on Phase 1 DLT-evaluable population for LA/mGC cohort, which included all enrolled and treated LA/mGC participants who did not experience any major protocol deviation and completed Cycle 1.'}, {'type': 'PRIMARY', 'title': 'Phase 1 (LA/mGC): MTD of Capecitabine When Combined With Trastuzumab Emtansine (2.4 mg/kg QW)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 1 (LA/mGC) Cohort 2 (DL -1): T-DM1 + Cape', 'description': 'In Phase 1, Cohort 2 participants (with LA/mGC) received trastuzumab emtansine at a dose of 2.4 mg/kg via IV infusion on Day 1 (Day 2 of first week) of every week along with capecitabine at a dose level of 700 mg/m\\^2 via tablet orally twice daily on Days 1-14 followed by a 7-day rest period, in each 21-day cycle until unacceptable toxicity, withdrawal of consent, PD, death, reasons deemed by the treating physician, or study termination by the sponsor.'}], 'classes': [{'categories': [{'measurements': [{'value': '700', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Continuously during 3 weeks', 'description': 'MTD was defined as the dose level for which the probability of DLT is equal to a protocol-specified target probability. A DLT was defined as any one of the following study treatment related toxicities: Uncomplicated Grade 4 thrombocytopenia that does not recover before Day 21; thrombocytopenia complicated with clinically significant bleeding requiring medical intervention; Grade 4 neutropenia lasting \\>7 consecutive days; febrile neutropenia with ANC \\<1000 cells/mm\\^3; Grade \\>/=3 diarrhea or Grade 3 hand-foot syndrome; any other Grade \\>/=3 toxicity prohibiting start of Cycle 2; Grade 2 toxicity requiring treatment interruption for \\>14 days; \\<14 full doses of capecitabine; Cycle 2 dose level \\<100%.', 'unitOfMeasure': 'mg/m^2', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on Phase 1 DLT-evaluable population for LA/mGC cohort.'}, {'type': 'SECONDARY', 'title': 'Phase 1 (mBC): Percentage of Participants With BOR as Assessed by the Investigator According to RECIST v1.1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 1 (mBC) Cohort 1 (DL 1): T-DM1 + Cape', 'description': 'In Phase 1, Cohort 1 participants (with mBC) received trastuzumab emtansine at a dose of 3.6 mg/kg via IV infusion (on Day 1 \\[on Day 2 for Cycle 1\\] of each 21-day cycle) along with capecitabine at a dose level of 750 mg/m\\^2 via tablet orally twice daily on Days 1-14 of each 21-day cycle until unacceptable toxicity, withdrawal of consent, PD, death, reasons deemed by the treating physician, or study termination by the sponsor.'}, {'id': 'OG001', 'title': 'Phase 1 (mBC) Cohort 1 (DL -1): T-DM1 + Cape', 'description': 'In Phase 1, Cohort 1 participants (with mBC) received trastuzumab emtansine at a dose of 3.6 mg/kg via IV infusion (on Day 1 \\[on Day 2 for Cycle 1\\] of each 21-day cycle) along with capecitabine at a dose level of 700 mg/m\\^2 via tablet orally twice daily on Days 1-14 of each 21-day cycle until unacceptable toxicity, withdrawal of consent, PD, death, reasons deemed by the treating physician, or study termination by the sponsor.'}], 'classes': [{'categories': [{'measurements': [{'value': '83.3', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline until CR/PR, consent withdrawal, or study end whichever occurred first (up to approximately 3.5 years overall)', 'description': 'Tumor response was assessed by the investigator according to RECIST v1.1. BOR in Phase 1 was defined as percentage of participants with a CR or PR. CR was defined as the disappearance of all TLs and non-TLs; SA reduction to \\<10 mm for nodal TLs/non-TLs; and no new lesions. PR was defined as \\>/=30% decrease in SoD of TLs, taking as reference the baseline SoD; no progression in non-TLs; and no new lesions.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on Phase 1 DLT-evaluable population for mBC cohort.'}, {'type': 'SECONDARY', 'title': 'Phase 1 (mBC): Serum Concentration of Trastuzumab Emtansine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 1 (mBC) Cohort 1 (DL 1): T-DM1 + Cape', 'description': 'In Phase 1, Cohort 1 participants (with mBC) received trastuzumab emtansine at a dose of 3.6 mg/kg via IV infusion (on Day 1 \\[on Day 2 for Cycle 1\\] of each 21-day cycle) along with capecitabine at a dose level of 750 mg/m\\^2 via tablet orally twice daily on Days 1-14 of each 21-day cycle until unacceptable toxicity, withdrawal of consent, PD, death, reasons deemed by the treating physician, or study termination by the sponsor.'}, {'id': 'OG001', 'title': 'Phase 1 (mBC) Cohort 1 (DL -1): T-DM1 + Cape', 'description': 'In Phase 1, Cohort 1 participants (with mBC) received trastuzumab emtansine at a dose of 3.6 mg/kg via IV infusion (on Day 1 \\[on Day 2 for Cycle 1\\] of each 21-day cycle) along with capecitabine at a dose level of 700 mg/m\\^2 via tablet orally twice daily on Days 1-14 of each 21-day cycle until unacceptable toxicity, withdrawal of consent, PD, death, reasons deemed by the treating physician, or study termination by the sponsor.'}], 'classes': [{'title': 'Cycle 1, Post-dose', 'categories': [{'measurements': [{'value': '81.3', 'spread': '13.3', 'groupId': 'OG000'}, {'value': '78.6', 'spread': '14.6', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 2, Pre-dose', 'categories': [{'measurements': [{'value': '1.17', 'spread': '1.25', 'groupId': 'OG000'}, {'value': '2.1', 'spread': '1.49', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 2, Post-dose', 'categories': [{'measurements': [{'value': '70.5', 'spread': '13.3', 'groupId': 'OG000'}, {'value': '78.5', 'spread': '14.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-trastuzumab emtansine dose (0 hour [h]) on Day 1 Cycle 2; 15-30 minutes (min) after end of trastuzumab emtansine infusion (maximum infusion duration = 90 min) on Day 2 Cycle 1 and Day 1 Cycle 2 (cycle length=21 days)', 'unitOfMeasure': 'micrograms per milliliter (mcg/mL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Phase 1 pharmacokinetic (PK) analysis population for mBC cohort; included all mBC participants receiving at least one dose of study medication during Phase 1 and had at least one reported serum/plasma result for PK. The PK analysis in mBC cohort included 1 patient who was excluded from the main safety and efficacy analyses due to ICF issues.'}, {'type': 'SECONDARY', 'title': 'Phase 1 (mBC): Serum Concentration of Trastuzumab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 1 (mBC) Cohort 1 (DL 1): T-DM1 + Cape', 'description': 'In Phase 1, Cohort 1 participants (with mBC) received trastuzumab emtansine at a dose of 3.6 mg/kg via IV infusion (on Day 1 \\[on Day 2 for Cycle 1\\] of each 21-day cycle) along with capecitabine at a dose level of 750 mg/m\\^2 via tablet orally twice daily on Days 1-14 of each 21-day cycle until unacceptable toxicity, withdrawal of consent, PD, death, reasons deemed by the treating physician, or study termination by the sponsor.'}, {'id': 'OG001', 'title': 'Phase 1 (mBC) Cohort 1 (DL -1): T-DM1 + Cape', 'description': 'In Phase 1, Cohort 1 participants (with mBC) received trastuzumab emtansine at a dose of 3.6 mg/kg via IV infusion (on Day 1 \\[on Day 2 for Cycle 1\\] of each 21-day cycle) along with capecitabine at a dose level of 700 mg/m\\^2 via tablet orally twice daily on Days 1-14 of each 21-day cycle until unacceptable toxicity, withdrawal of consent, PD, death, reasons deemed by the treating physician, or study termination by the sponsor.'}], 'classes': [{'title': 'Cycle 1, Post-dose', 'categories': [{'measurements': [{'value': '89.1', 'spread': '24.37', 'groupId': 'OG000'}, {'value': '92.9', 'spread': '22.13', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 2, Pre-dose', 'categories': [{'measurements': [{'value': '11.8', 'spread': '13.28', 'groupId': 'OG000'}, {'value': '14.0', 'spread': '12.53', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 2, Post-dose', 'categories': [{'measurements': [{'value': '74.8', 'spread': '18.89', 'groupId': 'OG000'}, {'value': '94.7', 'spread': '24.60', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-trastuzumab emtansine dose (0 h) on Day 1 Cycle 2; 15-30 min after end of trastuzumab emtansine infusion (maximum infusion duration = 90 min) on Day 2 Cycle 1 and Day 1 Cycle 2 (cycle length=21 days)', 'description': 'Trastuzumab was derived from trastuzumab emtansine.', 'unitOfMeasure': 'mcg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on Phase 1 PK analysis population for mBC cohort. The PK analysis in the mBC cohort included 1 patient who was excluded from the main safety and efficacy analyses due to ICF issues.'}, {'type': 'SECONDARY', 'title': 'Phase 1 (mBC): Maximum Observed Plasma Concentration (Cmax) of Capecitabine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 1 (mBC) Cohort 1 (DL 1): T-DM1 + Cape', 'description': 'In Phase 1, Cohort 1 participants (with mBC) received trastuzumab emtansine at a dose of 3.6 mg/kg via IV infusion (on Day 1 \\[on Day 2 for Cycle 1\\] of each 21-day cycle) along with capecitabine at a dose level of 750 mg/m\\^2 via tablet orally twice daily on Days 1-14 of each 21-day cycle until unacceptable toxicity, withdrawal of consent, PD, death, reasons deemed by the treating physician, or study termination by the sponsor.'}, {'id': 'OG001', 'title': 'Phase 1 (mBC) Cohort 1 (DL -1): T-DM1 + Cape', 'description': 'In Phase 1, Cohort 1 participants (with mBC) received trastuzumab emtansine at a dose of 3.6 mg/kg via IV infusion (on Day 1 \\[on Day 2 for Cycle 1\\] of each 21-day cycle) along with capecitabine at a dose level of 700 mg/m\\^2 via tablet orally twice daily on Days 1-14 of each 21-day cycle until unacceptable toxicity, withdrawal of consent, PD, death, reasons deemed by the treating physician, or study termination by the sponsor.'}], 'classes': [{'categories': [{'measurements': [{'value': '2990', 'spread': '38.4', 'groupId': 'OG000'}, {'value': '5652', 'spread': '91.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-capecitabine dose (0 h) and 0.5, 1, 1.5, 2, 2.5, 4, and 6 h post-capecitabine dose on Day 1 Cycle 1', 'description': 'Cmax for Capecitabine was estimated from plasma concentration versus time data using non-compartmental methods of analysis. Reported dispersion values are for percent coefficient of variation (CV%) and not for standard deviation.', 'unitOfMeasure': 'nanograms per milliliter (ng/mL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on Phase 1 PK analysis population for mBC cohort. The PK analysis in the mBC cohort included 1 patient who was excluded from the main safety and efficacy analyses due to ICF issues.'}, {'type': 'SECONDARY', 'title': 'Phase 1 (mBC): Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUC[0-inf]) of Capecitabine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 1 (mBC) Cohort 1 (DL 1): T-DM1 + Cape', 'description': 'In Phase 1, Cohort 1 participants (with mBC) received trastuzumab emtansine at a dose of 3.6 mg/kg via IV infusion (on Day 1 \\[on Day 2 for Cycle 1\\] of each 21-day cycle) along with capecitabine at a dose level of 750 mg/m\\^2 via tablet orally twice daily on Days 1-14 of each 21-day cycle until unacceptable toxicity, withdrawal of consent, PD, death, reasons deemed by the treating physician, or study termination by the sponsor.'}, {'id': 'OG001', 'title': 'Phase 1 (mBC) Cohort 1 (DL -1): T-DM1 + Cape', 'description': 'In Phase 1, Cohort 1 participants (with mBC) received trastuzumab emtansine at a dose of 3.6 mg/kg via IV infusion (on Day 1 \\[on Day 2 for Cycle 1\\] of each 21-day cycle) along with capecitabine at a dose level of 700 mg/m\\^2 via tablet orally twice daily on Days 1-14 of each 21-day cycle until unacceptable toxicity, withdrawal of consent, PD, death, reasons deemed by the treating physician, or study termination by the sponsor.'}], 'classes': [{'categories': [{'measurements': [{'value': '3973', 'spread': '38.0', 'groupId': 'OG000'}, {'value': '5440', 'spread': '57.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-capecitabine dose (0 h) and 0.5, 1, 1.5, 2, 2.5, 4, and 6 h post-capecitabine dose on Day 1 Cycle 1', 'description': 'AUC(0-inf) is the measure of total drug exposure and is dependent on the total amount of drug absorbed. AUC(0-inf) for capecitabine was estimated from plasma concentration versus time data using non-compartmental methods of analysis. Reported dispersion values are for CV% and not for standard deviation.', 'unitOfMeasure': 'hours*nanograms per milliliter (h*ng/mL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on Phase 1 PK analysis population for mBC cohort. The PK analysis in the mBC cohort included 1 patient who was excluded from the main safety and efficacy analyses due to ICF issues.'}, {'type': 'SECONDARY', 'title': 'Phase 1 (mBC): Plasma Terminal Half-Life (t1/2) of Capecitabine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 1 (mBC) Cohort 1 (DL 1): T-DM1 + Cape', 'description': 'In Phase 1, Cohort 1 participants (with mBC) received trastuzumab emtansine at a dose of 3.6 mg/kg via IV infusion (on Day 1 \\[on Day 2 for Cycle 1\\] of each 21-day cycle) along with capecitabine at a dose level of 750 mg/m\\^2 via tablet orally twice daily on Days 1-14 of each 21-day cycle until unacceptable toxicity, withdrawal of consent, PD, death, reasons deemed by the treating physician, or study termination by the sponsor.'}, {'id': 'OG001', 'title': 'Phase 1 (mBC) Cohort 1 (DL -1): T-DM1 + Cape', 'description': 'In Phase 1, Cohort 1 participants (with mBC) received trastuzumab emtansine at a dose of 3.6 mg/kg via IV infusion (on Day 1 \\[on Day 2 for Cycle 1\\] of each 21-day cycle) along with capecitabine at a dose level of 700 mg/m\\^2 via tablet orally twice daily on Days 1-14 of each 21-day cycle until unacceptable toxicity, withdrawal of consent, PD, death, reasons deemed by the treating physician, or study termination by the sponsor.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.70', 'spread': '131.9', 'groupId': 'OG000'}, {'value': '0.39', 'spread': '38.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-capecitabine dose (0 h) and 0.5, 1, 1.5, 2, 2.5, 4, and 6 h post-capecitabine dose on Day 1 Cycle 1', 'description': 'Plasma terminal half-life is the time measured for the plasma drug concentration to decrease by one half during the elimination phase of the drug. t1/2 for capecitabine was estimated from plasma concentration versus time data using non-compartmental methods of analysis. Reported dispersion values are for CV% and not for standard deviation.', 'unitOfMeasure': 'hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on Phase 1 PK analysis population for mBC cohort. The PK analysis in the mBC cohort included 1 patient who was excluded from the main safety and efficacy analyses due to ICF issues.'}, {'type': 'SECONDARY', 'title': 'Phase 1 (mBC): Cmax of 5-Fluorouracil (Metabolite of Capecitabine)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 1 (mBC) Cohort 1 (DL 1): T-DM1 + Cape', 'description': 'In Phase 1, Cohort 1 participants (with mBC) received trastuzumab emtansine at a dose of 3.6 mg/kg via IV infusion (on Day 1 \\[on Day 2 for Cycle 1\\] of each 21-day cycle) along with capecitabine at a dose level of 750 mg/m\\^2 via tablet orally twice daily on Days 1-14 of each 21-day cycle until unacceptable toxicity, withdrawal of consent, PD, death, reasons deemed by the treating physician, or study termination by the sponsor.'}, {'id': 'OG001', 'title': 'Phase 1 (mBC) Cohort 1 (DL -1): T-DM1 + Cape', 'description': 'In Phase 1, Cohort 1 participants (with mBC) received trastuzumab emtansine at a dose of 3.6 mg/kg via IV infusion (on Day 1 \\[on Day 2 for Cycle 1\\] of each 21-day cycle) along with capecitabine at a dose level of 700 mg/m\\^2 via tablet orally twice daily on Days 1-14 of each 21-day cycle until unacceptable toxicity, withdrawal of consent, PD, death, reasons deemed by the treating physician, or study termination by the sponsor.'}], 'classes': [{'categories': [{'measurements': [{'value': '148', 'spread': '49.9', 'groupId': 'OG000'}, {'value': '143', 'spread': '45.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-capecitabine dose (0 h) and 0.5, 1, 1.5, 2, 2.5, 4, and 6 h post-capecitabine dose on Day 1 Cycle 1', 'description': '5-fluorouracil is a metabolite of capecitabine. Cmax for 5-fluorouracil was estimated from plasma concentration versus time data using non-compartmental methods of analysis. Reported dispersion values are for CV% and not for standard deviation.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on Phase 1 PK analysis population for mBC cohort. The PK analysis in the mBC cohort included 1 patient who was excluded from the main safety and efficacy analyses due to ICF issues.'}, {'type': 'SECONDARY', 'title': 'Phase 1 (mBC): AUC(0-inf) of 5-Fluorouracil (Metabolite of Capecitabine)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 1 (mBC) Cohort 1 (DL 1): T-DM1 + Cape', 'description': 'In Phase 1, Cohort 1 participants (with mBC) received trastuzumab emtansine at a dose of 3.6 mg/kg via IV infusion (on Day 1 \\[on Day 2 for Cycle 1\\] of each 21-day cycle) along with capecitabine at a dose level of 750 mg/m\\^2 via tablet orally twice daily on Days 1-14 of each 21-day cycle until unacceptable toxicity, withdrawal of consent, PD, death, reasons deemed by the treating physician, or study termination by the sponsor.'}, {'id': 'OG001', 'title': 'Phase 1 (mBC) Cohort 1 (DL -1): T-DM1 + Cape', 'description': 'In Phase 1, Cohort 1 participants (with mBC) received trastuzumab emtansine at a dose of 3.6 mg/kg via IV infusion (on Day 1 \\[on Day 2 for Cycle 1\\] of each 21-day cycle) along with capecitabine at a dose level of 700 mg/m\\^2 via tablet orally twice daily on Days 1-14 of each 21-day cycle until unacceptable toxicity, withdrawal of consent, PD, death, reasons deemed by the treating physician, or study termination by the sponsor.'}], 'classes': [{'categories': [{'measurements': [{'value': '257', 'spread': '49.9', 'groupId': 'OG000'}, {'value': '244', 'spread': '38.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-capecitabine dose (0 h) and 0.5, 1, 1.5, 2, 2.5, 4, and 6 h post-capecitabine dose on Day 1 Cycle 1', 'description': '5-fluorouracil is a metabolite of capecitabine. AUC(0-inf) is the measure of total drug exposure and is dependent on the total amount of drug absorbed. AUC(0-inf) for 5-fluorouracil was estimated from plasma concentration versus time data using non-compartmental methods of analysis. Reported dispersion values are for CV% and not for standard deviation.', 'unitOfMeasure': 'h*ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on Phase 1 PK analysis population for mBC cohort. The PK analysis in the mBC cohort included 1 patient who was excluded from the main safety and efficacy analyses due to ICF issues.'}, {'type': 'SECONDARY', 'title': 'Phase 1 (mBC): t1/2 of 5-Fluorouracil (Metabolite of Capecitabine)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 1 (mBC) Cohort 1 (DL 1): T-DM1 + Cape', 'description': 'In Phase 1, Cohort 1 participants (with mBC) received trastuzumab emtansine at a dose of 3.6 mg/kg via IV infusion (on Day 1 \\[on Day 2 for Cycle 1\\] of each 21-day cycle) along with capecitabine at a dose level of 750 mg/m\\^2 via tablet orally twice daily on Days 1-14 of each 21-day cycle until unacceptable toxicity, withdrawal of consent, PD, death, reasons deemed by the treating physician, or study termination by the sponsor.'}, {'id': 'OG001', 'title': 'Phase 1 (mBC) Cohort 1 (DL -1): T-DM1 + Cape', 'description': 'In Phase 1, Cohort 1 participants (with mBC) received trastuzumab emtansine at a dose of 3.6 mg/kg via IV infusion (on Day 1 \\[on Day 2 for Cycle 1\\] of each 21-day cycle) along with capecitabine at a dose level of 700 mg/m\\^2 via tablet orally twice daily on Days 1-14 of each 21-day cycle until unacceptable toxicity, withdrawal of consent, PD, death, reasons deemed by the treating physician, or study termination by the sponsor.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.63', 'spread': '39.5', 'groupId': 'OG000'}, {'value': '0.64', 'spread': '18.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-capecitabine dose (0 h) and 0.5, 1, 1.5, 2, 2.5, 4, and 6 h post-capecitabine dose on Day 1 Cycle 1', 'description': '5-fluorouracil is a metabolite of capecitabine. Plasma terminal half-life is the time measured for the plasma drug concentration to decrease by one half during the elimination phase of the drug. t1/2 for 5-fluorouracil was estimated from plasma concentration versus time data using non-compartmental methods of analysis. Reported dispersion values are for CV% and not for standard deviation.', 'unitOfMeasure': 'hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on Phase 1 PK analysis population for mBC cohort. The PK analysis in the mBC cohort included 1 patient who was excluded from the main safety and efficacy analyses due to ICF issues.'}, {'type': 'SECONDARY', 'title': 'Phase 2 (mBC): Time to Response (TTR) as Assessed by the Investigator According to RECIST v1.1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 2 (mBC): T-DM1 + Cape', 'description': 'In Phase 2, participants (with mBC) who were randomized to this group received trastuzumab emtansine at a dose of 3.6 mg/kg via IV infusion on Day 1 of each 21-day cycle along with capecitabine at a dose level of 700 mg/m\\^2 via tablet orally twice daily on Days 1-14 of each 21-day cycle until unacceptable toxicity, withdrawal of consent, PD, death, reasons deemed by the treating physician, or study termination by the sponsor.'}, {'id': 'OG001', 'title': 'Phase 2 (mBC): T-DM1', 'description': 'In Phase 2, participants (with mBC) who were randomized to this group received trastuzumab emtansine at a dose of 3.6 mg/kg via IV infusion on Day 1 of each 21-day cycle until investigator-assessed PD, unacceptable toxicity, withdrawal of consent, death, reasons deemed by the treating physician, or study termination by the Sponsor.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.10', 'groupId': 'OG000', 'lowerLimit': '1.2', 'upperLimit': '10.8'}, {'value': '2.10', 'groupId': 'OG001', 'lowerLimit': '1.9', 'upperLimit': '8.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline until first documentation of confirmed PR or CR, whichever occurred first (up to approximately 2.5 years overall)', 'description': 'Tumor response was assessed by the investigator according to RECIST v1.1. TTR was defined as the time (in months) from randomization to first documentation of confirmed PR or CR (whichever occurred first). CR was defined as the disappearance of all TLs and non-TLs; SA reduction to \\<10 mm for nodal TLs/non-TLs; and no new lesions. PR was defined as \\>/=30% decrease in SoD of TLs, taking as reference the baseline SoD; no progression in non-TLs; and no new lesions.', 'unitOfMeasure': 'months', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on ITT Population. Only participants with a BOR of CR or PR were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Phase 2 (mBC): Duration of Response (DoR) as Assessed by the Investigator According to RECIST v1.1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 2 (mBC): T-DM1 + Cape', 'description': 'In Phase 2, participants (with mBC) who were randomized to this group received trastuzumab emtansine at a dose of 3.6 mg/kg via IV infusion on Day 1 of each 21-day cycle along with capecitabine at a dose level of 700 mg/m\\^2 via tablet orally twice daily on Days 1-14 of each 21-day cycle until unacceptable toxicity, withdrawal of consent, PD, death, reasons deemed by the treating physician, or study termination by the sponsor.'}, {'id': 'OG001', 'title': 'Phase 2 (mBC): T-DM1', 'description': 'In Phase 2, participants (with mBC) who were randomized to this group received trastuzumab emtansine at a dose of 3.6 mg/kg via IV infusion on Day 1 of each 21-day cycle until investigator-assessed PD, unacceptable toxicity, withdrawal of consent, death, reasons deemed by the treating physician, or study termination by the Sponsor.'}], 'classes': [{'categories': [{'measurements': [{'value': '11.30', 'comment': 'Upper limit of 90% CI could not be calculated due to insufficient number of participants who had an event.', 'groupId': 'OG000', 'lowerLimit': '8.61', 'upperLimit': 'NA'}, {'value': '12.22', 'groupId': 'OG001', 'lowerLimit': '8.84', 'upperLimit': '15.97'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From the documentation of response until PD, death, consent withdrawal, or study end whichever occurred first (up to approximately 2.5 years overall)', 'description': 'Tumor response was assessed by the investigator according to RECIST v1.1. DoR was defined as the time (in months) from the date of first recorded PR/CR until the date of PD or death from any cause. CR: the disappearance of all TLs and non-TLs; SA reduction to \\<10 mm for nodal TLs/non-TLs; and no new lesions. PR: \\>/=30% decrease in SoD of TLs, taking as reference the baseline SoD; no progression in non-TLs; and no new lesions. PD: \\>/=20% relative increase with \\>/=5 mm of absolute increase in the SoD, taking as reference the smallest SoD recorded since treatment started; 1 or more new lesion(s); and/or unequivocal progression of non-TLs. Participants with no documented PD after CR/PR were censored at the time of last tumor assessment. Participants without post-baseline tumor assessment were censored at randomization plus 1 day. The median DOR and 90% CI were estimated using Kaplan-Meier method.', 'unitOfMeasure': 'months', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on ITT Population. Only participants with a BOR of CR or PR were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Phase 2 (mBC): Percentage of Participants With PD as Assessed by the Investigator According to RECIST v1.1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 2 (mBC): T-DM1 + Cape', 'description': 'In Phase 2, participants (with mBC) who were randomized to this group received trastuzumab emtansine at a dose of 3.6 mg/kg via IV infusion on Day 1 of each 21-day cycle along with capecitabine at a dose level of 700 mg/m\\^2 via tablet orally twice daily on Days 1-14 of each 21-day cycle until unacceptable toxicity, withdrawal of consent, PD, death, reasons deemed by the treating physician, or study termination by the sponsor.'}, {'id': 'OG001', 'title': 'Phase 2 (mBC): T-DM1', 'description': 'In Phase 2, participants (with mBC) who were randomized to this group received trastuzumab emtansine at a dose of 3.6 mg/kg via IV infusion on Day 1 of each 21-day cycle until investigator-assessed PD, unacceptable toxicity, withdrawal of consent, death, reasons deemed by the treating physician, or study termination by the Sponsor.'}], 'classes': [{'categories': [{'measurements': [{'value': '64.2', 'groupId': 'OG000'}, {'value': '70.0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline until PD, consent withdrawal, or study end whichever occurred first (up to approximately 2.5 years overall)', 'description': 'Tumor response was assessed by the investigator according to RECIST v1.1. PD was defined as \\>/=20% relative increase with \\>/=5 mm of absolute increase in the SoD, taking as reference the smallest SoD recorded since treatment started; 1 or more new lesion(s); and/or unequivocal progression of non-TLs.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on ITT Population.'}, {'type': 'SECONDARY', 'title': 'Phase 2 (mBC): Time to Progression (TTP) as Assessed by the Investigator According to RECIST v1.1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 2 (mBC): T-DM1 + Cape', 'description': 'In Phase 2, participants (with mBC) who were randomized to this group received trastuzumab emtansine at a dose of 3.6 mg/kg via IV infusion on Day 1 of each 21-day cycle along with capecitabine at a dose level of 700 mg/m\\^2 via tablet orally twice daily on Days 1-14 of each 21-day cycle until unacceptable toxicity, withdrawal of consent, PD, death, reasons deemed by the treating physician, or study termination by the sponsor.'}, {'id': 'OG001', 'title': 'Phase 2 (mBC): T-DM1', 'description': 'In Phase 2, participants (with mBC) who were randomized to this group received trastuzumab emtansine at a dose of 3.6 mg/kg via IV infusion on Day 1 of each 21-day cycle until investigator-assessed PD, unacceptable toxicity, withdrawal of consent, death, reasons deemed by the treating physician, or study termination by the Sponsor.'}], 'classes': [{'categories': [{'measurements': [{'value': '10.38', 'groupId': 'OG000', 'lowerLimit': '7.85', 'upperLimit': '12.91'}, {'value': '10.32', 'groupId': 'OG001', 'lowerLimit': '7.56', 'upperLimit': '13.27'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline until PD, consent withdrawal, or study end whichever occurred first (up to approximately 2.5 years overall)', 'description': 'Tumor response was assessed by the investigator according to RECIST v1.1. TTP was defined as the time (in months) from randomization to the first occurrence of PD. PD was defined as \\>/=20% relative increase with \\>/=5 mm of absolute increase in the SoD, taking as reference the smallest SoD recorded since treatment started; 1 or more new lesion(s); and/or unequivocal progression of non-TLs. Participants with no documented PD at the time of study end (including participants who died before PD) or who were lost to follow-up were censored on the date of the last tumor assessment. The median TTP and 90% CI was estimated using Kaplan-Meier method.', 'unitOfMeasure': 'months', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on ITT Population.'}, {'type': 'SECONDARY', 'title': 'Phase 2 (mBC): Percentage of Participants With Treatment Failure as Assessed by the Investigator According to RECIST v1.1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 2 (mBC): T-DM1 + Cape', 'description': 'In Phase 2, participants (with mBC) who were randomized to this group received trastuzumab emtansine at a dose of 3.6 mg/kg via IV infusion on Day 1 of each 21-day cycle along with capecitabine at a dose level of 700 mg/m\\^2 via tablet orally twice daily on Days 1-14 of each 21-day cycle until unacceptable toxicity, withdrawal of consent, PD, death, reasons deemed by the treating physician, or study termination by the sponsor.'}, {'id': 'OG001', 'title': 'Phase 2 (mBC): T-DM1', 'description': 'In Phase 2, participants (with mBC) who were randomized to this group received trastuzumab emtansine at a dose of 3.6 mg/kg via IV infusion on Day 1 of each 21-day cycle until investigator-assessed PD, unacceptable toxicity, withdrawal of consent, death, reasons deemed by the treating physician, or study termination by the Sponsor.'}], 'classes': [{'categories': [{'measurements': [{'value': '77.8', 'groupId': 'OG000'}, {'value': '83.8', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline until treatment failure, consent withdrawal, or study end whichever occurred first (up to approximately 2.5 years overall)', 'description': 'Treatment failure was defined as occurrence of any of the following event while on treatment: PD, death, withdrawal due to adverse event (AE) or laboratory abnormality, or refusal of treatment. PD as assessed by the investigator according to RECIST v1.1 was defined as \\>/=20% relative increase with \\>/=5 mm of absolute increase in the SoD, taking as reference the smallest SoD recorded since treatment started; 1 or more new lesion(s); and/or unequivocal progression of non-TLs.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on ITT Population.'}, {'type': 'SECONDARY', 'title': 'Phase 2 (mBC): Time to Treatment Failure (TTF) as Assessed by the Investigator According to RECIST v1.1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 2 (mBC): T-DM1 + Cape', 'description': 'In Phase 2, participants (with mBC) who were randomized to this group received trastuzumab emtansine at a dose of 3.6 mg/kg via IV infusion on Day 1 of each 21-day cycle along with capecitabine at a dose level of 700 mg/m\\^2 via tablet orally twice daily on Days 1-14 of each 21-day cycle until unacceptable toxicity, withdrawal of consent, PD, death, reasons deemed by the treating physician, or study termination by the sponsor.'}, {'id': 'OG001', 'title': 'Phase 2 (mBC): T-DM1', 'description': 'In Phase 2, participants (with mBC) who were randomized to this group received trastuzumab emtansine at a dose of 3.6 mg/kg via IV infusion on Day 1 of each 21-day cycle until investigator-assessed PD, unacceptable toxicity, withdrawal of consent, death, reasons deemed by the treating physician, or study termination by the Sponsor.'}], 'classes': [{'categories': [{'measurements': [{'value': '9.86', 'groupId': 'OG000', 'lowerLimit': '7.62', 'upperLimit': '10.68'}, {'value': '7.66', 'groupId': 'OG001', 'lowerLimit': '6.54', 'upperLimit': '10.68'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline until treatment failure, consent withdrawal, or study end whichever occurred first (up to approximately 2.5 years overall)', 'description': 'TTF was defined as the time (in months) from randomization until treatment failure (PD, death, withdrawal due to AE or laboratory abnormality, or refusal of treatment). PD as assessed by the investigator according to RECIST v1.1 was defined as \\>/=20% relative increase with \\>/=5 mm of absolute increase in the SoD, taking as reference the smallest SoD recorded since treatment started; 1 or more new lesion(s); and/or unequivocal progression of non-TLs. Participants who did not experience any of the above events while on study were censored on the date of their last tumor assessment. The median TTF and 90% CI was estimated using Kaplan-Meier method.', 'unitOfMeasure': 'months', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on ITT Population.'}, {'type': 'SECONDARY', 'title': 'Phase 2 (mBC): Percentage of Participants With PD as Assessed by the Investigator According to RECIST v1.1 or Death From Any Cause', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 2 (mBC): T-DM1 + Cape', 'description': 'In Phase 2, participants (with mBC) who were randomized to this group received trastuzumab emtansine at a dose of 3.6 mg/kg via IV infusion on Day 1 of each 21-day cycle along with capecitabine at a dose level of 700 mg/m\\^2 via tablet orally twice daily on Days 1-14 of each 21-day cycle until unacceptable toxicity, withdrawal of consent, PD, death, reasons deemed by the treating physician, or study termination by the sponsor.'}, {'id': 'OG001', 'title': 'Phase 2 (mBC): T-DM1', 'description': 'In Phase 2, participants (with mBC) who were randomized to this group received trastuzumab emtansine at a dose of 3.6 mg/kg via IV infusion on Day 1 of each 21-day cycle until investigator-assessed PD, unacceptable toxicity, withdrawal of consent, death, reasons deemed by the treating physician, or study termination by the Sponsor.'}], 'classes': [{'categories': [{'measurements': [{'value': '67.9', 'groupId': 'OG000'}, {'value': '73.8', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline until PD, death from any cause, consent withdrawal, or study end whichever occurred first (up to approximately 2.5 years overall)', 'description': 'Tumor response was assessed by the investigator according to RECIST v1.1. PD was defined as \\>/=20% relative increase with \\>/=5 mm of absolute increase in the SoD, taking as reference the smallest SoD recorded since treatment started; 1 or more new lesion(s); and/or unequivocal progression of non-TLs.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on ITT Population.'}, {'type': 'SECONDARY', 'title': 'Phase 2 (mBC): Progression-Free Survival (PFS) as Assessed by the Investigator According to RECIST v1.1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 2 (mBC): T-DM1 + Cape', 'description': 'In Phase 2, participants (with mBC) who were randomized to this group received trastuzumab emtansine at a dose of 3.6 mg/kg via IV infusion on Day 1 of each 21-day cycle along with capecitabine at a dose level of 700 mg/m\\^2 via tablet orally twice daily on Days 1-14 of each 21-day cycle until unacceptable toxicity, withdrawal of consent, PD, death, reasons deemed by the treating physician, or study termination by the sponsor.'}, {'id': 'OG001', 'title': 'Phase 2 (mBC): T-DM1', 'description': 'In Phase 2, participants (with mBC) who were randomized to this group received trastuzumab emtansine at a dose of 3.6 mg/kg via IV infusion on Day 1 of each 21-day cycle until investigator-assessed PD, unacceptable toxicity, withdrawal of consent, death, reasons deemed by the treating physician, or study termination by the Sponsor.'}], 'classes': [{'categories': [{'measurements': [{'value': '10.15', 'groupId': 'OG000', 'lowerLimit': '7.85', 'upperLimit': '12.55'}, {'value': '9.82', 'groupId': 'OG001', 'lowerLimit': '7.46', 'upperLimit': '13.08'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline until PD, death from any cause, consent withdrawal, or study end whichever occurred first (up to approximately 2.5 years overall)', 'description': 'Tumor response was assessed by the investigator according to RECIST v1.1. PFS was defined as the time (in months) from randomization until the first documented PD or death from any cause, whichever occurred first. PD was defined as \\>/=20% relative increase with \\>/=5 mm of absolute increase in the SoD, taking as reference the smallest SoD recorded since treatment started; 1 or more new lesion(s); and/or unequivocal progression of non-TLs. Participants with no PFS events were censored on the date of the last tumor assessment. Participants without post-baseline tumor assessment were censored at randomization plus 1 day. The median PFS and 90% CI was estimated using Kaplan-Meier method.', 'unitOfMeasure': 'months', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on ITT Population.'}, {'type': 'SECONDARY', 'title': 'Phase 2 (mBC): Percentage of Participants With Clinical Benefit as Assessed by the Investigator According to RECIST v1.1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 2 (mBC): T-DM1 + Cape', 'description': 'In Phase 2, participants (with mBC) who were randomized to this group received trastuzumab emtansine at a dose of 3.6 mg/kg via IV infusion on Day 1 of each 21-day cycle along with capecitabine at a dose level of 700 mg/m\\^2 via tablet orally twice daily on Days 1-14 of each 21-day cycle until unacceptable toxicity, withdrawal of consent, PD, death, reasons deemed by the treating physician, or study termination by the sponsor.'}, {'id': 'OG001', 'title': 'Phase 2 (mBC): T-DM1', 'description': 'In Phase 2, participants (with mBC) who were randomized to this group received trastuzumab emtansine at a dose of 3.6 mg/kg via IV infusion on Day 1 of each 21-day cycle until investigator-assessed PD, unacceptable toxicity, withdrawal of consent, death, reasons deemed by the treating physician, or study termination by the Sponsor.'}], 'classes': [{'categories': [{'measurements': [{'value': '66.7', 'groupId': 'OG000', 'lowerLimit': '57.1', 'upperLimit': '75.3'}, {'value': '62.5', 'groupId': 'OG001', 'lowerLimit': '52.7', 'upperLimit': '71.6'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline until clinical benefit response, consent withdrawal, or study end whichever occurred first (up to approximately 2.5 years overall)', 'description': 'The clinical benefit was defined as a confirmed response of CR, PR, or stable disease (SD) that lasted for at least 6 months. Tumor response was assessed by the investigator according to RECIST v1.1. CR: the disappearance of all TLs and non-TLs; SA reduction to \\<10 mm for nodal TLs/non-TLs; and no new lesions. PR: \\>/=30% decrease in SoD of TLs, taking as reference the baseline SoD; no progression in non-TLs; and no new lesions. PD: \\>/=20% relative increase with \\>/=5 mm of absolute increase in the SoD, taking as reference the smallest SoD recorded since treatment started; 1 or more new lesion(s); and/or unequivocal progression of non-TLs. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest SoD on study. The 90% CI was computed using Clopper-Pearson approach.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on ITT Population.'}, {'type': 'SECONDARY', 'title': 'Phase 2 (mBC): Percentage of Participants Who Died of Any Cause', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 2 (mBC): T-DM1 + Cape', 'description': 'In Phase 2, participants (with mBC) who were randomized to this group received trastuzumab emtansine at a dose of 3.6 mg/kg via IV infusion on Day 1 of each 21-day cycle along with capecitabine at a dose level of 700 mg/m\\^2 via tablet orally twice daily on Days 1-14 of each 21-day cycle until unacceptable toxicity, withdrawal of consent, PD, death, reasons deemed by the treating physician, or study termination by the sponsor.'}, {'id': 'OG001', 'title': 'Phase 2 (mBC): T-DM1', 'description': 'In Phase 2, participants (with mBC) who were randomized to this group received trastuzumab emtansine at a dose of 3.6 mg/kg via IV infusion on Day 1 of each 21-day cycle until investigator-assessed PD, unacceptable toxicity, withdrawal of consent, death, reasons deemed by the treating physician, or study termination by the Sponsor.'}], 'classes': [{'categories': [{'measurements': [{'value': '22.2', 'groupId': 'OG000'}, {'value': '26.3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline until death or study end whichever occurred first (up to approximately 2.5 years overall)', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on ITT Population.'}, {'type': 'SECONDARY', 'title': 'Phase 2 (mBC): Overall Survival (OS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 2 (mBC): T-DM1 + Cape', 'description': 'In Phase 2, participants (with mBC) who were randomized to this group received trastuzumab emtansine at a dose of 3.6 mg/kg via IV infusion on Day 1 of each 21-day cycle along with capecitabine at a dose level of 700 mg/m\\^2 via tablet orally twice daily on Days 1-14 of each 21-day cycle until unacceptable toxicity, withdrawal of consent, PD, death, reasons deemed by the treating physician, or study termination by the sponsor.'}, {'id': 'OG001', 'title': 'Phase 2 (mBC): T-DM1', 'description': 'In Phase 2, participants (with mBC) who were randomized to this group received trastuzumab emtansine at a dose of 3.6 mg/kg via IV infusion on Day 1 of each 21-day cycle until investigator-assessed PD, unacceptable toxicity, withdrawal of consent, death, reasons deemed by the treating physician, or study termination by the Sponsor.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Median and 90% CI could not be calculated due to insufficient number of participants who had an event.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '24.71', 'comment': 'Upper limit of 90% CI could not be calculated due to insufficient number of participants who had an event.', 'groupId': 'OG001', 'lowerLimit': '24.28', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline until death or study end whichever occurred first (up to approximately 2.5 years overall)', 'description': 'OS was defined as the time (in months) from randomization until death from any cause. Participants who were alive at the time of data cut-off were censored on the date of the last follow-up assessment. Participants who were lost to follow-up were censored as having no event (alive) on the date of last contact. The median OS and 90% CI was estimated using Kaplan-Meier method, which use the patients at risk as denominator rather than the whole number of patients.', 'unitOfMeasure': 'months', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on ITT Population.'}, {'type': 'SECONDARY', 'title': 'Phase 1 (LA/mGC): Percentage of Participants With BOR as Assessed by the Investigator According to RECIST v1.1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 1 (LA/mGC) Cohort 2 (DL -1): T-DM1 + Cape', 'description': 'In Phase 1, Cohort 2 participants (with LA/mGC) received trastuzumab emtansine at a dose of 2.4 mg/kg via IV infusion on Day 1 (Day 2 of first week) of every week along with capecitabine at a dose level of 700 mg/m\\^2 via tablet orally twice daily on Days 1-14 followed by a 7-day rest period, in each 21-day cycle until unacceptable toxicity, withdrawal of consent, PD, death, reasons deemed by the treating physician, or study termination by the sponsor.'}], 'classes': [{'categories': [{'measurements': [{'value': '83.3', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline until CR/PR, consent withdrawal, or study end whichever occurred first (up to approximately 1.5 years overall)', 'description': 'Tumor response was assessed by the investigator according to RECIST v1.1. BOR in Phase 1 was defined as percentage of participants with a CR or PR. CR was defined as the disappearance of all TLs and non-TLs; SA reduction to \\<10 mm for nodal TLs/non-TLs; and no new lesions. PR was defined as \\>/=30% decrease in SoD of TLs, taking as reference the baseline SoD; no progression in non-TLs; and no new lesions.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on Phase 1 DLT-evaluable population for LA/mGC cohort.'}, {'type': 'SECONDARY', 'title': 'Phase 1 (LA/mGC): Serum Concentration of Trastuzumab Emtansine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 1 (LA/mGC) Cohort 2 (DL -1): T-DM1 + Cape', 'description': 'In Phase 1, Cohort 2 participants (with LA/mGC) received trastuzumab emtansine at a dose of 2.4 mg/kg via IV infusion on Day 1 (Day 2 of first week) of every week along with capecitabine at a dose level of 700 mg/m\\^2 via tablet orally twice daily on Days 1-14 followed by a 7-day rest period, in each 21-day cycle until unacceptable toxicity, withdrawal of consent, PD, death, reasons deemed by the treating physician, or study termination by the sponsor.'}], 'classes': [{'title': 'Cycle 1, Post-dose', 'categories': [{'measurements': [{'value': '30.1', 'spread': '14.5', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 2, Pre-dose', 'categories': [{'measurements': [{'value': '10.1', 'spread': '5.85', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 2, Post-dose', 'categories': [{'measurements': [{'value': '46.4', 'spread': '7.74', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-trastuzumab emtansine dose (0 h) on Day 1 Cycle 2; 15-30 min after end of trastuzumab emtansine infusion (maximum infusion duration = 90 min) on Day 2 Cycle 1 and Day 1 Cycle 2 (cycle length=21 days)', 'unitOfMeasure': 'mcg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on Phase 1 PK analysis population for LA/mGC cohort.'}, {'type': 'SECONDARY', 'title': 'Phase 1 (LA/mGC): Serum Concentration of Trastuzumab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 1 (LA/mGC) Cohort 2 (DL -1): T-DM1 + Cape', 'description': 'In Phase 1, Cohort 2 participants (with LA/mGC) received trastuzumab emtansine at a dose of 2.4 mg/kg via IV infusion on Day 1 (Day 2 of first week) of every week along with capecitabine at a dose level of 700 mg/m\\^2 via tablet orally twice daily on Days 1-14 followed by a 7-day rest period, in each 21-day cycle until unacceptable toxicity, withdrawal of consent, PD, death, reasons deemed by the treating physician, or study termination by the sponsor.'}], 'classes': [{'title': 'Cycle 1, Post-dose', 'categories': [{'measurements': [{'value': '33.1', 'spread': '15.98', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 2, Pre-dose', 'categories': [{'measurements': [{'value': '18.5', 'spread': '7.57', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 2, Post-dose', 'categories': [{'measurements': [{'value': '57.6', 'spread': '13.55', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-trastuzumab emtansine dose (0 h) on Day 1 Cycle 2; 15-30 min after end of trastuzumab emtansine infusion (maximum infusion duration = 90 min) on Day 2 Cycle 1 and Day 1 Cycle 2 (cycle length=21 days)', 'description': 'Trastuzumab was derived from trastuzumab emtansine.', 'unitOfMeasure': 'mcg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on Phase 1 PK analysis population for LA/mGC cohort.'}, {'type': 'SECONDARY', 'title': 'Phase 1 (LA/mGC): Cmax of Capecitabine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 1 (LA/mGC) Cohort 2 (DL -1): T-DM1 + Cape', 'description': 'In Phase 1, Cohort 2 participants (with LA/mGC) received trastuzumab emtansine at a dose of 2.4 mg/kg via IV infusion on Day 1 (Day 2 of first week) of every week along with capecitabine at a dose level of 700 mg/m\\^2 via tablet orally twice daily on Days 1-14 followed by a 7-day rest period, in each 21-day cycle until unacceptable toxicity, withdrawal of consent, PD, death, reasons deemed by the treating physician, or study termination by the sponsor.'}], 'classes': [{'categories': [{'measurements': [{'value': '4925', 'spread': '36.3', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-capecitabine dose (0 h) and 0.5, 1, 1.5, 2, 2.5, 4, and 6 h post-capecitabine dose on Day 1 Cycle 1', 'description': 'Cmax for capecitabine was estimated from plasma concentration versus time data using non-compartmental methods of analysis. Reported dispersion values are for CV% and not for standard deviation.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on Phase 1 PK analysis population for LA/mGC cohort.'}, {'type': 'SECONDARY', 'title': 'Phase 1 (LA/mGC): AUC(0-inf) of Capecitabine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 1 (LA/mGC) Cohort 2 (DL -1): T-DM1 + Cape', 'description': 'In Phase 1, Cohort 2 participants (with LA/mGC) received trastuzumab emtansine at a dose of 2.4 mg/kg via IV infusion on Day 1 (Day 2 of first week) of every week along with capecitabine at a dose level of 700 mg/m\\^2 via tablet orally twice daily on Days 1-14 followed by a 7-day rest period, in each 21-day cycle until unacceptable toxicity, withdrawal of consent, PD, death, reasons deemed by the treating physician, or study termination by the sponsor.'}], 'classes': [{'categories': [{'measurements': [{'value': '5131', 'spread': '24.6', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-capecitabine dose (0 h) and 0.5, 1, 1.5, 2, 2.5, 4, and 6 h post-capecitabine dose on Day 1 Cycle 1', 'description': 'AUC(0-inf) is the measure of total drug exposure and is dependent on the total amount of drug absorbed. AUC(0-inf) for capecitabine was estimated from plasma concentration versus time data using non-compartmental methods of analysis. Reported dispersion values are for CV% and not for standard deviation.', 'unitOfMeasure': 'h*ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on Phase 1 PK analysis population for LA/mGC cohort.'}, {'type': 'SECONDARY', 'title': 'Phase 1 (LA/mGC): t1/2 of Capecitabine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 1 (LA/mGC) Cohort 2 (DL -1): T-DM1 + Cape', 'description': 'In Phase 1, Cohort 2 participants (with LA/mGC) received trastuzumab emtansine at a dose of 2.4 mg/kg via IV infusion on Day 1 (Day 2 of first week) of every week along with capecitabine at a dose level of 700 mg/m\\^2 via tablet orally twice daily on Days 1-14 followed by a 7-day rest period, in each 21-day cycle until unacceptable toxicity, withdrawal of consent, PD, death, reasons deemed by the treating physician, or study termination by the sponsor.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.65', 'spread': '34.5', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-capecitabine dose (0 h) and 0.5, 1, 1.5, 2, 2.5, 4, and 6 h post-capecitabine dose on Day 1 Cycle 1', 'description': 'Plasma terminal half-life is the time measured for the plasma drug concentration to decrease by one half during the elimination phase of the drug. t1/2 for capecitabine was estimated from plasma concentration versus time data using non-compartmental methods of analysis. Reported dispersion values are for CV% and not for standard deviation.', 'unitOfMeasure': 'hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on Phase 1 PK analysis population for LA/mGC cohort.'}, {'type': 'SECONDARY', 'title': 'Phase 1 (LA/mGC): Cmax of 5-Fluorouracil (Metabolite of Capecitabine)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 1 (LA/mGC) Cohort 2 (DL -1): T-DM1 + Cape', 'description': 'In Phase 1, Cohort 2 participants (with LA/mGC) received trastuzumab emtansine at a dose of 2.4 mg/kg via IV infusion on Day 1 (Day 2 of first week) of every week along with capecitabine at a dose level of 700 mg/m\\^2 via tablet orally twice daily on Days 1-14 followed by a 7-day rest period, in each 21-day cycle until unacceptable toxicity, withdrawal of consent, PD, death, reasons deemed by the treating physician, or study termination by the sponsor.'}], 'classes': [{'categories': [{'measurements': [{'value': '137', 'spread': '24.3', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-capecitabine dose (0 h) and 0.5, 1, 1.5, 2, 2.5, 4, and 6 h post-capecitabine dose on Day 1 Cycle 1', 'description': '5-fluorouracil is a metabolite of capecitabine. Cmax for 5-fluorouracil was estimated from plasma concentration versus time data using non-compartmental methods of analysis. Reported dispersion values are for CV% and not for standard deviation.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on Phase 1 PK analysis population for LA/mGC cohort.'}, {'type': 'SECONDARY', 'title': 'Phase 1 (LA/mGC): AUC(0-inf) of 5-Fluorouracil (Metabolite of Capecitabine)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 1 (LA/mGC) Cohort 2 (DL -1): T-DM1 + Cape', 'description': 'In Phase 1, Cohort 2 participants (with LA/mGC) received trastuzumab emtansine at a dose of 2.4 mg/kg via IV infusion on Day 1 (Day 2 of first week) of every week along with capecitabine at a dose level of 700 mg/m\\^2 via tablet orally twice daily on Days 1-14 followed by a 7-day rest period, in each 21-day cycle until unacceptable toxicity, withdrawal of consent, PD, death, reasons deemed by the treating physician, or study termination by the sponsor.'}], 'classes': [{'categories': [{'measurements': [{'value': '213', 'spread': '16.2', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-capecitabine dose (0 h) and 0.5, 1, 1.5, 2, 2.5, 4, and 6 h post-capecitabine dose on Day 1 Cycle 1', 'description': '5-fluorouracil is a metabolite of capecitabine. AUC(0-inf) is the measure of total drug exposure and is dependent on the total amount of drug absorbed. AUC(0-inf) for 5-fluorouracil was estimated from plasma concentration versus time data using non-compartmental methods of analysis. Reported dispersion values are for CV% and not for standard deviation.', 'unitOfMeasure': 'h*ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on Phase 1 PK analysis population for LA/mGC cohort.'}, {'type': 'SECONDARY', 'title': 'Phase 1 (LA/mGC): t1/2 of 5-Fluorouracil (Metabolite of Capecitabine)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 1 (LA/mGC) Cohort 2 (DL -1): T-DM1 + Cape', 'description': 'In Phase 1, Cohort 2 participants (with LA/mGC) received trastuzumab emtansine at a dose of 2.4 mg/kg via IV infusion on Day 1 (Day 2 of first week) of every week along with capecitabine at a dose level of 700 mg/m\\^2 via tablet orally twice daily on Days 1-14 followed by a 7-day rest period, in each 21-day cycle until unacceptable toxicity, withdrawal of consent, PD, death, reasons deemed by the treating physician, or study termination by the sponsor.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.83', 'spread': '17.0', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-capecitabine dose (0 h) and 0.5, 1, 1.5, 2, 2.5, 4, and 6 h post-capecitabine dose on Day 1 Cycle 1', 'description': '5-fluorouracil is a metabolite of capecitabine. Plasma terminal half-life is the time measured for the plasma drug concentration to decrease by one half during the elimination phase of the drug. t1/2 for 5-fluorouracil was estimated from plasma concentration versus time data using non-compartmental methods of analysis. Reported dispersion values are for CV% and not for standard deviation.', 'unitOfMeasure': 'hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on Phase 1 PK analysis population for LA/mGC cohort.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Phase 1 (mBC) Cohort 1 (DL 1): T-DM1 + Cape', 'description': 'In Phase 1, Cohort 1 participants (with mBC) received trastuzumab emtansine (T-DM1) at a dose of 3.6 milligrams per kilogram (mg/kg) via intravenous (IV) infusion (on Day 1 \\[on Day 2 for Cycle 1\\] of each 21-day cycle) along with capecitabine (Cape) at a dose level (DL) of 750 milligrams per meter squared (mg/m\\^2) via tablet orally twice daily on Days 1-14 of each 21-day cycle until unacceptable toxicity, withdrawal of consent, disease progression (PD), death, reasons deemed by the treating physician, or study termination by the sponsor.'}, {'id': 'FG001', 'title': 'Phase 1 (mBC) Cohort 1 (DL -1): T-DM1 + Cape', 'description': 'In Phase 1, Cohort 1 participants (with mBC) received trastuzumab emtansine at a dose of 3.6 mg/kg via IV infusion (on Day 1 \\[on Day 2 for Cycle 1\\] of each 21-day cycle) along with capecitabine at a dose level of 700 mg/m\\^2 via tablet orally twice daily on Days 1-14 of each 21-day cycle until unacceptable toxicity, withdrawal of consent, PD, death, reasons deemed by the treating physician, or study termination by the sponsor.'}, {'id': 'FG002', 'title': 'Phase 1 (LA/mGC) Cohort 2 (DL -1): T-DM1 + Cape', 'description': 'In Phase 1, Cohort 2 participants (with LA/mGC) received trastuzumab emtansine at a dose of 2.4 mg/kg via IV infusion on Day 1 (Day 2 of first week) of every week along with capecitabine at a dose level of 700 mg/m\\^2 via tablet orally twice daily on Days 1-14 followed by a 7-day rest period, in each 21-day cycle until unacceptable toxicity, withdrawal of consent, PD, death, reasons deemed by the treating physician, or study termination by the sponsor.'}, {'id': 'FG003', 'title': 'Phase 2 (mBC): T-DM1 + Cape', 'description': 'In Phase 2, participants (with mBC) who were randomized to this group received trastuzumab emtansine at a dose of 3.6 mg/kg via IV infusion on Day 1 of each 21-day cycle along with capecitabine at a dose level of 700 mg/m\\^2 via tablet orally twice daily on Days 1-14 of each 21-day cycle until unacceptable toxicity, withdrawal of consent, PD, death, reasons deemed by the treating physician, or study termination by the sponsor.'}, {'id': 'FG004', 'title': 'Phase 2 (mBC): T-DM1', 'description': 'In Phase 2, participants (with mBC) who were randomized in this group received trastuzumab emtansine at a dose of 3.6 mg/kg via IV infusion on Day 1 of each 21-day cycle until investigator-assessed PD, unacceptable toxicity, withdrawal of consent, death, reasons deemed by the treating physician, or study termination by the Sponsor.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '81'}, {'groupId': 'FG004', 'numSubjects': '80'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '34'}, {'groupId': 'FG004', 'numSubjects': '38'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '47'}, {'groupId': 'FG004', 'numSubjects': '42'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '12'}, {'groupId': 'FG004', 'numSubjects': '4'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '16'}, {'groupId': 'FG004', 'numSubjects': '20'}]}, {'type': 'Safety Follow-Up less than 3 Months', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Study Terminated by Sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '16'}, {'groupId': 'FG004', 'numSubjects': '17'}]}]}], 'preAssignmentDetails': 'A total of 234 participants were screened, out of which, 182 participants were enrolled into the study. Out of the 182 enrolled participants, 3 participants were excluded from all safety and efficacy analyses because they did not sign correct Informed Consent Form (ICF).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '82', 'groupId': 'BG003'}, {'value': '78', 'groupId': 'BG004'}, {'value': '178', 'groupId': 'BG005'}]}], 'groups': [{'id': 'BG000', 'title': 'Phase 1 (mBC) Cohort 1 (DL 1): T-DM1 + Cape', 'description': 'In Phase 1, Cohort 1 participants (with mBC) received trastuzumab emtansine at a dose of 3.6 mg/kg via IV infusion (on Day 1 \\[on Day 2 for Cycle 1\\] of each 21-day cycle) along with capecitabine at a dose level of 750 mg/m\\^2 via tablet orally twice daily on Days 1-14 of each 21-day cycle until unacceptable toxicity, withdrawal of consent, PD, death, reasons deemed by the treating physician, or study termination by the sponsor.'}, {'id': 'BG001', 'title': 'Phase 1 (mBC) Cohort 1 (DL -1): T-DM1 + Cape', 'description': 'In Phase 1, Cohort 1 participants (with mBC) received trastuzumab emtansine at a dose of 3.6 mg/kg via IV infusion (on Day 1 \\[on Day 2 for Cycle 1\\] of each 21-day cycle) along with capecitabine at a dose level of 700 mg/m\\^2 via tablet orally twice daily on Days 1-14 of each 21-day cycle until unacceptable toxicity, withdrawal of consent, PD, death, reasons deemed by the treating physician, or study termination by the sponsor.'}, {'id': 'BG002', 'title': 'Phase 1 (LA/mGC) Cohort 2 (DL -1): T-DM1 + Cape', 'description': 'In Phase 1, Cohort 2 participants (with LA/mGC) received trastuzumab emtansine at a dose of 2.4 mg/kg via IV infusion on Day 1 (Day 2 of first week) of every week along with capecitabine at a dose level of 700 mg/m\\^2 via tablet orally twice daily on Days 1-14 followed by a 7-day rest period, in each 21-day cycle until unacceptable toxicity, withdrawal of consent, PD, death, reasons deemed by the treating physician, or study termination by the sponsor.'}, {'id': 'BG003', 'title': 'Phase 2 (mBC): T-DM1 + Cape', 'description': 'In Phase 2, participants (with mBC) who were randomized to this group received trastuzumab emtansine at a dose of 3.6 mg/kg via IV infusion on Day 1 of each 21-day cycle along with capecitabine at a dose level of 700 mg/m\\^2 via tablet orally twice daily on Days 1-14 of each 21-day cycle until unacceptable toxicity, withdrawal of consent, PD, death, reasons deemed by the treating physician, or study termination by the sponsor.'}, {'id': 'BG004', 'title': 'Phase 2 (mBC): T-DM1', 'description': 'In Phase 2, participants (with mBC) who were randomized to this group received trastuzumab emtansine at a dose of 3.6 mg/kg via IV infusion on Day 1 of each 21-day cycle until investigator-assessed PD, unacceptable toxicity, withdrawal of consent, death, reasons deemed by the treating physician, or study termination by the Sponsor.'}, {'id': 'BG005', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '55.9', 'spread': '10.75', 'groupId': 'BG000'}, {'value': '50.8', 'spread': '7.76', 'groupId': 'BG001'}, {'value': '60.0', 'spread': '7.40', 'groupId': 'BG002'}, {'value': '53.3', 'spread': '11.69', 'groupId': 'BG003'}, {'value': '52.6', 'spread': '11.19', 'groupId': 'BG004'}, {'value': '53.2', 'spread': '11.22', 'groupId': 'BG005'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '81', 'groupId': 'BG003'}, {'value': '78', 'groupId': 'BG004'}, {'value': '170', 'groupId': 'BG005'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '8', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Race: Caucasian', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '71', 'groupId': 'BG003'}, {'value': '65', 'groupId': 'BG004'}, {'value': '152', 'groupId': 'BG005'}]}]}, {'title': 'Race: N/A (as per local regulation)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '7', 'groupId': 'BG004'}, {'value': '19', 'groupId': 'BG005'}]}]}, {'title': 'Race: Black', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}]}]}, {'title': 'Race: Asian', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}]}]}, {'title': 'Race: Mixed', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}]}]}, {'title': 'Ethnicity: Hispanic/Latino', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '10', 'groupId': 'BG004'}, {'value': '16', 'groupId': 'BG005'}]}]}, {'title': 'Ethnicity: Chinese', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}]}]}, {'title': 'Ethnicity: Other', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '39', 'groupId': 'BG003'}, {'value': '35', 'groupId': 'BG004'}, {'value': '80', 'groupId': 'BG005'}]}]}, {'title': 'Ethnicity: N/A (as per local regulation)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '32', 'groupId': 'BG003'}, {'value': '29', 'groupId': 'BG004'}, {'value': '69', 'groupId': 'BG005'}]}]}, {'title': 'Ethnicity: Unknown', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '11', 'groupId': 'BG005'}]}]}, {'title': 'Ethnicity: Mixed', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Safety population: Participants who received \\>/=1 dose of study drug, analyzed as per actual treatment received. In Phase 2, of 161 participants, 1 was randomized in error(received no treatment) and was excluded from safety analysis and 1 who was randomized to T-DM1 alone Arm received Capecitabine throughout study and was counted in T-DM1+Cape Arm.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-03-26', 'size': 13489011, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2018-05-28T15:21', 'hasProtocol': True}, {'date': '2017-09-07', 'size': 8917149, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2018-05-28T15:22', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 182}}, 'statusModule': {'whyStopped': 'The sponsor decided to terminate study after 70% of participants had experienced a progression-free survival event.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2012-12-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2017-05-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-19', 'studyFirstSubmitDate': '2012-10-04', 'resultsFirstSubmitDate': '2018-05-28', 'studyFirstSubmitQcDate': '2012-10-05', 'lastUpdatePostDateStruct': {'date': '2021-01-22', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-01-08', 'studyFirstPostDateStruct': {'date': '2012-10-08', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-04-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-05-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Phase 1 (mBC): Percentage of Participants With Dose-Limiting Toxicities (DLTs)', 'timeFrame': 'Continuously during Cycle 1 (up to 3 weeks)', 'description': 'A DLT was defined as any one of the following study treatment related toxicities: Uncomplicated Grade 4 thrombocytopenia that does not recover before Day 21; thrombocytopenia complicated with clinically significant bleeding requiring medical intervention; Grade 4 neutropenia lasting more than (\\>) 7 consecutive days; febrile neutropenia with absolute neutrophil count (ANC) less than (\\<) 1000 cells/millimeter cube (mm\\^3); Grade greater than or equal to (\\>/=) 3 diarrhea or Grade 3 hand-foot syndrome (in absence of dihydropyrimidine dehydrogenase \\[DPD\\] deficiency only for DL 1); any other Grade \\>/=3 toxicity prohibiting start of Cycle 2; Grade 2 toxicity requiring treatment interruption for \\>14 days (\\>7 days for DL 1); for DL -1 only: \\<14 full doses of capecitabine; Cycle 2 dose level \\<100 percent (%).'}, {'measure': 'Phase 1 (mBC): Maximum Tolerated Dose (MTD) of Capecitabine When Combined With Trastuzumab Emtansine (3.6 mg/kg Every 3 Weeks)', 'timeFrame': 'Continuously during Cycle 1 (up to 3 weeks)', 'description': 'MTD was defined as the dose level for which the probability of DLT is equal to a protocol-specified target probability. A DLT was defined as any one of the following study treatment related toxicities: Uncomplicated Grade 4 thrombocytopenia that does not recover before Day 21; thrombocytopenia complicated with clinically significant bleeding requiring medical intervention; Grade 4 neutropenia lasting \\>7 consecutive days; febrile neutropenia with ANC \\<1000 cells/mm\\^3; Grade \\>/=3 diarrhea or Grade 3 hand-foot syndrome (in absence of DPD deficiency only for DL 1); any other Grade \\>/=3 toxicity prohibiting start of Cycle 2; Grade 2 toxicity requiring treatment interruption for \\>14 days (\\>7 days for DL 1); for DL -1 only: \\<14 full doses of capecitabine; Cycle 2 dose level \\<100%.'}, {'measure': 'Phase 2 (mBC): Percentage of Participants With Best Overall Response (BOR) as Assessed by the Investigator According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)', 'timeFrame': 'Baseline until CR/PR, consent withdrawal, or study end whichever occurred first (up to approximately 2.5 years overall)', 'description': 'Tumor response was assessed by the investigator according to RECIST v1.1. BOR was defined as percentage of participants with a complete response (CR) or partial response (PR) that was confirmed by repeat assessments \\>/=4 weeks after initial documentation. CR was defined as the disappearance of all target lesions (TLs) and non-TLs; short axis (SA) reduction to \\<10 millimeters (mm) for nodal TLs/non-TLs; and no new lesions. PR was defined as \\>/=30% decrease in sum of diameters (SoD) of TLs, taking as reference the baseline SoD; no progression in non-TLs; and no new lesions. The 90% confidence Interval (CI) was computed using Clopper-Pearson approach.'}, {'measure': 'Phase 1 (LA/mGC): Percentage of Participants With DLTs', 'timeFrame': 'Continuously during 3 weeks', 'description': 'A DLT was defined as any one of the following study treatment related toxicities: Uncomplicated Grade 4 thrombocytopenia that does not recover before Day 21; thrombocytopenia complicated with clinically significant bleeding requiring medical intervention; Grade 4 neutropenia lasting \\>7 consecutive days; febrile neutropenia with ANC \\<1000 cells/mm\\^3; Grade \\>/=3 diarrhea or Grade 3 hand-foot syndrome; any other Grade \\>/=3 toxicity prohibiting start of Cycle 2; Grade 2 toxicity requiring treatment interruption for \\>14 days; \\<14 full doses of capecitabine; Cycle 2 dose level \\<100%.'}, {'measure': 'Phase 1 (LA/mGC): MTD of Capecitabine When Combined With Trastuzumab Emtansine (2.4 mg/kg QW)', 'timeFrame': 'Continuously during 3 weeks', 'description': 'MTD was defined as the dose level for which the probability of DLT is equal to a protocol-specified target probability. A DLT was defined as any one of the following study treatment related toxicities: Uncomplicated Grade 4 thrombocytopenia that does not recover before Day 21; thrombocytopenia complicated with clinically significant bleeding requiring medical intervention; Grade 4 neutropenia lasting \\>7 consecutive days; febrile neutropenia with ANC \\<1000 cells/mm\\^3; Grade \\>/=3 diarrhea or Grade 3 hand-foot syndrome; any other Grade \\>/=3 toxicity prohibiting start of Cycle 2; Grade 2 toxicity requiring treatment interruption for \\>14 days; \\<14 full doses of capecitabine; Cycle 2 dose level \\<100%.'}], 'secondaryOutcomes': [{'measure': 'Phase 1 (mBC): Percentage of Participants With BOR as Assessed by the Investigator According to RECIST v1.1', 'timeFrame': 'Baseline until CR/PR, consent withdrawal, or study end whichever occurred first (up to approximately 3.5 years overall)', 'description': 'Tumor response was assessed by the investigator according to RECIST v1.1. BOR in Phase 1 was defined as percentage of participants with a CR or PR. CR was defined as the disappearance of all TLs and non-TLs; SA reduction to \\<10 mm for nodal TLs/non-TLs; and no new lesions. PR was defined as \\>/=30% decrease in SoD of TLs, taking as reference the baseline SoD; no progression in non-TLs; and no new lesions.'}, {'measure': 'Phase 1 (mBC): Serum Concentration of Trastuzumab Emtansine', 'timeFrame': 'Pre-trastuzumab emtansine dose (0 hour [h]) on Day 1 Cycle 2; 15-30 minutes (min) after end of trastuzumab emtansine infusion (maximum infusion duration = 90 min) on Day 2 Cycle 1 and Day 1 Cycle 2 (cycle length=21 days)'}, {'measure': 'Phase 1 (mBC): Serum Concentration of Trastuzumab', 'timeFrame': 'Pre-trastuzumab emtansine dose (0 h) on Day 1 Cycle 2; 15-30 min after end of trastuzumab emtansine infusion (maximum infusion duration = 90 min) on Day 2 Cycle 1 and Day 1 Cycle 2 (cycle length=21 days)', 'description': 'Trastuzumab was derived from trastuzumab emtansine.'}, {'measure': 'Phase 1 (mBC): Maximum Observed Plasma Concentration (Cmax) of Capecitabine', 'timeFrame': 'Pre-capecitabine dose (0 h) and 0.5, 1, 1.5, 2, 2.5, 4, and 6 h post-capecitabine dose on Day 1 Cycle 1', 'description': 'Cmax for Capecitabine was estimated from plasma concentration versus time data using non-compartmental methods of analysis. Reported dispersion values are for percent coefficient of variation (CV%) and not for standard deviation.'}, {'measure': 'Phase 1 (mBC): Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUC[0-inf]) of Capecitabine', 'timeFrame': 'Pre-capecitabine dose (0 h) and 0.5, 1, 1.5, 2, 2.5, 4, and 6 h post-capecitabine dose on Day 1 Cycle 1', 'description': 'AUC(0-inf) is the measure of total drug exposure and is dependent on the total amount of drug absorbed. AUC(0-inf) for capecitabine was estimated from plasma concentration versus time data using non-compartmental methods of analysis. Reported dispersion values are for CV% and not for standard deviation.'}, {'measure': 'Phase 1 (mBC): Plasma Terminal Half-Life (t1/2) of Capecitabine', 'timeFrame': 'Pre-capecitabine dose (0 h) and 0.5, 1, 1.5, 2, 2.5, 4, and 6 h post-capecitabine dose on Day 1 Cycle 1', 'description': 'Plasma terminal half-life is the time measured for the plasma drug concentration to decrease by one half during the elimination phase of the drug. t1/2 for capecitabine was estimated from plasma concentration versus time data using non-compartmental methods of analysis. Reported dispersion values are for CV% and not for standard deviation.'}, {'measure': 'Phase 1 (mBC): Cmax of 5-Fluorouracil (Metabolite of Capecitabine)', 'timeFrame': 'Pre-capecitabine dose (0 h) and 0.5, 1, 1.5, 2, 2.5, 4, and 6 h post-capecitabine dose on Day 1 Cycle 1', 'description': '5-fluorouracil is a metabolite of capecitabine. Cmax for 5-fluorouracil was estimated from plasma concentration versus time data using non-compartmental methods of analysis. Reported dispersion values are for CV% and not for standard deviation.'}, {'measure': 'Phase 1 (mBC): AUC(0-inf) of 5-Fluorouracil (Metabolite of Capecitabine)', 'timeFrame': 'Pre-capecitabine dose (0 h) and 0.5, 1, 1.5, 2, 2.5, 4, and 6 h post-capecitabine dose on Day 1 Cycle 1', 'description': '5-fluorouracil is a metabolite of capecitabine. AUC(0-inf) is the measure of total drug exposure and is dependent on the total amount of drug absorbed. AUC(0-inf) for 5-fluorouracil was estimated from plasma concentration versus time data using non-compartmental methods of analysis. Reported dispersion values are for CV% and not for standard deviation.'}, {'measure': 'Phase 1 (mBC): t1/2 of 5-Fluorouracil (Metabolite of Capecitabine)', 'timeFrame': 'Pre-capecitabine dose (0 h) and 0.5, 1, 1.5, 2, 2.5, 4, and 6 h post-capecitabine dose on Day 1 Cycle 1', 'description': '5-fluorouracil is a metabolite of capecitabine. Plasma terminal half-life is the time measured for the plasma drug concentration to decrease by one half during the elimination phase of the drug. t1/2 for 5-fluorouracil was estimated from plasma concentration versus time data using non-compartmental methods of analysis. Reported dispersion values are for CV% and not for standard deviation.'}, {'measure': 'Phase 2 (mBC): Time to Response (TTR) as Assessed by the Investigator According to RECIST v1.1', 'timeFrame': 'Baseline until first documentation of confirmed PR or CR, whichever occurred first (up to approximately 2.5 years overall)', 'description': 'Tumor response was assessed by the investigator according to RECIST v1.1. TTR was defined as the time (in months) from randomization to first documentation of confirmed PR or CR (whichever occurred first). CR was defined as the disappearance of all TLs and non-TLs; SA reduction to \\<10 mm for nodal TLs/non-TLs; and no new lesions. PR was defined as \\>/=30% decrease in SoD of TLs, taking as reference the baseline SoD; no progression in non-TLs; and no new lesions.'}, {'measure': 'Phase 2 (mBC): Duration of Response (DoR) as Assessed by the Investigator According to RECIST v1.1', 'timeFrame': 'From the documentation of response until PD, death, consent withdrawal, or study end whichever occurred first (up to approximately 2.5 years overall)', 'description': 'Tumor response was assessed by the investigator according to RECIST v1.1. DoR was defined as the time (in months) from the date of first recorded PR/CR until the date of PD or death from any cause. CR: the disappearance of all TLs and non-TLs; SA reduction to \\<10 mm for nodal TLs/non-TLs; and no new lesions. PR: \\>/=30% decrease in SoD of TLs, taking as reference the baseline SoD; no progression in non-TLs; and no new lesions. PD: \\>/=20% relative increase with \\>/=5 mm of absolute increase in the SoD, taking as reference the smallest SoD recorded since treatment started; 1 or more new lesion(s); and/or unequivocal progression of non-TLs. Participants with no documented PD after CR/PR were censored at the time of last tumor assessment. Participants without post-baseline tumor assessment were censored at randomization plus 1 day. The median DOR and 90% CI were estimated using Kaplan-Meier method.'}, {'measure': 'Phase 2 (mBC): Percentage of Participants With PD as Assessed by the Investigator According to RECIST v1.1', 'timeFrame': 'Baseline until PD, consent withdrawal, or study end whichever occurred first (up to approximately 2.5 years overall)', 'description': 'Tumor response was assessed by the investigator according to RECIST v1.1. PD was defined as \\>/=20% relative increase with \\>/=5 mm of absolute increase in the SoD, taking as reference the smallest SoD recorded since treatment started; 1 or more new lesion(s); and/or unequivocal progression of non-TLs.'}, {'measure': 'Phase 2 (mBC): Time to Progression (TTP) as Assessed by the Investigator According to RECIST v1.1', 'timeFrame': 'Baseline until PD, consent withdrawal, or study end whichever occurred first (up to approximately 2.5 years overall)', 'description': 'Tumor response was assessed by the investigator according to RECIST v1.1. TTP was defined as the time (in months) from randomization to the first occurrence of PD. PD was defined as \\>/=20% relative increase with \\>/=5 mm of absolute increase in the SoD, taking as reference the smallest SoD recorded since treatment started; 1 or more new lesion(s); and/or unequivocal progression of non-TLs. Participants with no documented PD at the time of study end (including participants who died before PD) or who were lost to follow-up were censored on the date of the last tumor assessment. The median TTP and 90% CI was estimated using Kaplan-Meier method.'}, {'measure': 'Phase 2 (mBC): Percentage of Participants With Treatment Failure as Assessed by the Investigator According to RECIST v1.1', 'timeFrame': 'Baseline until treatment failure, consent withdrawal, or study end whichever occurred first (up to approximately 2.5 years overall)', 'description': 'Treatment failure was defined as occurrence of any of the following event while on treatment: PD, death, withdrawal due to adverse event (AE) or laboratory abnormality, or refusal of treatment. PD as assessed by the investigator according to RECIST v1.1 was defined as \\>/=20% relative increase with \\>/=5 mm of absolute increase in the SoD, taking as reference the smallest SoD recorded since treatment started; 1 or more new lesion(s); and/or unequivocal progression of non-TLs.'}, {'measure': 'Phase 2 (mBC): Time to Treatment Failure (TTF) as Assessed by the Investigator According to RECIST v1.1', 'timeFrame': 'Baseline until treatment failure, consent withdrawal, or study end whichever occurred first (up to approximately 2.5 years overall)', 'description': 'TTF was defined as the time (in months) from randomization until treatment failure (PD, death, withdrawal due to AE or laboratory abnormality, or refusal of treatment). PD as assessed by the investigator according to RECIST v1.1 was defined as \\>/=20% relative increase with \\>/=5 mm of absolute increase in the SoD, taking as reference the smallest SoD recorded since treatment started; 1 or more new lesion(s); and/or unequivocal progression of non-TLs. Participants who did not experience any of the above events while on study were censored on the date of their last tumor assessment. The median TTF and 90% CI was estimated using Kaplan-Meier method.'}, {'measure': 'Phase 2 (mBC): Percentage of Participants With PD as Assessed by the Investigator According to RECIST v1.1 or Death From Any Cause', 'timeFrame': 'Baseline until PD, death from any cause, consent withdrawal, or study end whichever occurred first (up to approximately 2.5 years overall)', 'description': 'Tumor response was assessed by the investigator according to RECIST v1.1. PD was defined as \\>/=20% relative increase with \\>/=5 mm of absolute increase in the SoD, taking as reference the smallest SoD recorded since treatment started; 1 or more new lesion(s); and/or unequivocal progression of non-TLs.'}, {'measure': 'Phase 2 (mBC): Progression-Free Survival (PFS) as Assessed by the Investigator According to RECIST v1.1', 'timeFrame': 'Baseline until PD, death from any cause, consent withdrawal, or study end whichever occurred first (up to approximately 2.5 years overall)', 'description': 'Tumor response was assessed by the investigator according to RECIST v1.1. PFS was defined as the time (in months) from randomization until the first documented PD or death from any cause, whichever occurred first. PD was defined as \\>/=20% relative increase with \\>/=5 mm of absolute increase in the SoD, taking as reference the smallest SoD recorded since treatment started; 1 or more new lesion(s); and/or unequivocal progression of non-TLs. Participants with no PFS events were censored on the date of the last tumor assessment. Participants without post-baseline tumor assessment were censored at randomization plus 1 day. The median PFS and 90% CI was estimated using Kaplan-Meier method.'}, {'measure': 'Phase 2 (mBC): Percentage of Participants With Clinical Benefit as Assessed by the Investigator According to RECIST v1.1', 'timeFrame': 'Baseline until clinical benefit response, consent withdrawal, or study end whichever occurred first (up to approximately 2.5 years overall)', 'description': 'The clinical benefit was defined as a confirmed response of CR, PR, or stable disease (SD) that lasted for at least 6 months. Tumor response was assessed by the investigator according to RECIST v1.1. CR: the disappearance of all TLs and non-TLs; SA reduction to \\<10 mm for nodal TLs/non-TLs; and no new lesions. PR: \\>/=30% decrease in SoD of TLs, taking as reference the baseline SoD; no progression in non-TLs; and no new lesions. PD: \\>/=20% relative increase with \\>/=5 mm of absolute increase in the SoD, taking as reference the smallest SoD recorded since treatment started; 1 or more new lesion(s); and/or unequivocal progression of non-TLs. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest SoD on study. The 90% CI was computed using Clopper-Pearson approach.'}, {'measure': 'Phase 2 (mBC): Percentage of Participants Who Died of Any Cause', 'timeFrame': 'Baseline until death or study end whichever occurred first (up to approximately 2.5 years overall)'}, {'measure': 'Phase 2 (mBC): Overall Survival (OS)', 'timeFrame': 'Baseline until death or study end whichever occurred first (up to approximately 2.5 years overall)', 'description': 'OS was defined as the time (in months) from randomization until death from any cause. Participants who were alive at the time of data cut-off were censored on the date of the last follow-up assessment. Participants who were lost to follow-up were censored as having no event (alive) on the date of last contact. The median OS and 90% CI was estimated using Kaplan-Meier method, which use the patients at risk as denominator rather than the whole number of patients.'}, {'measure': 'Phase 1 (LA/mGC): Percentage of Participants With BOR as Assessed by the Investigator According to RECIST v1.1', 'timeFrame': 'Baseline until CR/PR, consent withdrawal, or study end whichever occurred first (up to approximately 1.5 years overall)', 'description': 'Tumor response was assessed by the investigator according to RECIST v1.1. BOR in Phase 1 was defined as percentage of participants with a CR or PR. CR was defined as the disappearance of all TLs and non-TLs; SA reduction to \\<10 mm for nodal TLs/non-TLs; and no new lesions. PR was defined as \\>/=30% decrease in SoD of TLs, taking as reference the baseline SoD; no progression in non-TLs; and no new lesions.'}, {'measure': 'Phase 1 (LA/mGC): Serum Concentration of Trastuzumab Emtansine', 'timeFrame': 'Pre-trastuzumab emtansine dose (0 h) on Day 1 Cycle 2; 15-30 min after end of trastuzumab emtansine infusion (maximum infusion duration = 90 min) on Day 2 Cycle 1 and Day 1 Cycle 2 (cycle length=21 days)'}, {'measure': 'Phase 1 (LA/mGC): Serum Concentration of Trastuzumab', 'timeFrame': 'Pre-trastuzumab emtansine dose (0 h) on Day 1 Cycle 2; 15-30 min after end of trastuzumab emtansine infusion (maximum infusion duration = 90 min) on Day 2 Cycle 1 and Day 1 Cycle 2 (cycle length=21 days)', 'description': 'Trastuzumab was derived from trastuzumab emtansine.'}, {'measure': 'Phase 1 (LA/mGC): Cmax of Capecitabine', 'timeFrame': 'Pre-capecitabine dose (0 h) and 0.5, 1, 1.5, 2, 2.5, 4, and 6 h post-capecitabine dose on Day 1 Cycle 1', 'description': 'Cmax for capecitabine was estimated from plasma concentration versus time data using non-compartmental methods of analysis. Reported dispersion values are for CV% and not for standard deviation.'}, {'measure': 'Phase 1 (LA/mGC): AUC(0-inf) of Capecitabine', 'timeFrame': 'Pre-capecitabine dose (0 h) and 0.5, 1, 1.5, 2, 2.5, 4, and 6 h post-capecitabine dose on Day 1 Cycle 1', 'description': 'AUC(0-inf) is the measure of total drug exposure and is dependent on the total amount of drug absorbed. AUC(0-inf) for capecitabine was estimated from plasma concentration versus time data using non-compartmental methods of analysis. Reported dispersion values are for CV% and not for standard deviation.'}, {'measure': 'Phase 1 (LA/mGC): t1/2 of Capecitabine', 'timeFrame': 'Pre-capecitabine dose (0 h) and 0.5, 1, 1.5, 2, 2.5, 4, and 6 h post-capecitabine dose on Day 1 Cycle 1', 'description': 'Plasma terminal half-life is the time measured for the plasma drug concentration to decrease by one half during the elimination phase of the drug. t1/2 for capecitabine was estimated from plasma concentration versus time data using non-compartmental methods of analysis. Reported dispersion values are for CV% and not for standard deviation.'}, {'measure': 'Phase 1 (LA/mGC): Cmax of 5-Fluorouracil (Metabolite of Capecitabine)', 'timeFrame': 'Pre-capecitabine dose (0 h) and 0.5, 1, 1.5, 2, 2.5, 4, and 6 h post-capecitabine dose on Day 1 Cycle 1', 'description': '5-fluorouracil is a metabolite of capecitabine. Cmax for 5-fluorouracil was estimated from plasma concentration versus time data using non-compartmental methods of analysis. Reported dispersion values are for CV% and not for standard deviation.'}, {'measure': 'Phase 1 (LA/mGC): AUC(0-inf) of 5-Fluorouracil (Metabolite of Capecitabine)', 'timeFrame': 'Pre-capecitabine dose (0 h) and 0.5, 1, 1.5, 2, 2.5, 4, and 6 h post-capecitabine dose on Day 1 Cycle 1', 'description': '5-fluorouracil is a metabolite of capecitabine. AUC(0-inf) is the measure of total drug exposure and is dependent on the total amount of drug absorbed. AUC(0-inf) for 5-fluorouracil was estimated from plasma concentration versus time data using non-compartmental methods of analysis. Reported dispersion values are for CV% and not for standard deviation.'}, {'measure': 'Phase 1 (LA/mGC): t1/2 of 5-Fluorouracil (Metabolite of Capecitabine)', 'timeFrame': 'Pre-capecitabine dose (0 h) and 0.5, 1, 1.5, 2, 2.5, 4, and 6 h post-capecitabine dose on Day 1 Cycle 1', 'description': '5-fluorouracil is a metabolite of capecitabine. Plasma terminal half-life is the time measured for the plasma drug concentration to decrease by one half during the elimination phase of the drug. t1/2 for 5-fluorouracil was estimated from plasma concentration versus time data using non-compartmental methods of analysis. Reported dispersion values are for CV% and not for standard deviation.'}]}, 'conditionsModule': {'conditions': ['Breast Cancer', 'Gastric Cancer']}, 'referencesModule': {'references': [{'pmid': '32584367', 'type': 'DERIVED', 'citation': 'Cortes J, Dieras V, Lorenzen S, Montemurro F, Riera-Knorrenschild J, Thuss-Patience P, Allegrini G, De Laurentiis M, Lohrisch C, Oravcova E, Perez-Garcia JM, Ricci F, Sakaeva D, Serpanchy R, Sufliarsky J, Vidal M, Irahara N, Wohlfarth C, Aout M, Gelmon K. Efficacy and Safety of Trastuzumab Emtansine Plus Capecitabine vs Trastuzumab Emtansine Alone in Patients With Previously Treated ERBB2 (HER2)-Positive Metastatic Breast Cancer: A Phase 1 and Randomized Phase 2 Trial. JAMA Oncol. 2020 Aug 1;6(8):1203-1209. doi: 10.1001/jamaoncol.2020.1796.'}]}, 'descriptionModule': {'briefSummary': 'This multicenter study will assess the maximum tolerated dose (MTD) of capecitabine in combination with Kadcyla (trastuzumab emtansine) in participants with HER2-positive mBC or HER2-positive LA/mGC using a Phase 1 design, followed by a randomized, open-label Phase 2 part to explore the efficacy and safety of the combination of Kadcyla and capecitabine compared with Kadcyla alone in participants with mBC. The anticipated time on study treatment is until disease progression, intolerable toxicity, withdrawal of consent, or study end.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nMetastatic Breast Cancer\n\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2\n* Adequate blood cell count\n* Adequate liver, renal, and cardiac function\n* Life expectancy greater than or equal to (\\>/=) 12 weeks\n* Histologically or cytologically confirmed breast cancer\n* Confirmed HER2-positive disease, defined as immunohistochemistry (IHC) 3+ or in situ hybridization (ISH)-positive\n* mBC with at least one measurable lesion according to RECIST v1.1\n* Disease progression on at least one prior regimen containing trastuzumab and chemotherapy either separately or in combination; participants may be eligible to receive study therapy in first-line setting if trastuzumab and chemotherapy were given in the neoadjuvant/adjuvant setting\n* Participant must have recovered from previous treatments\n\nLocally Advanced/Metastatic Gastric Cancer\n\n* ECOG performance status of 0, 1, or 2\n* Adequate blood cell count\n* Adequate liver, renal, and cardiac function\n* Life expectancy \\>/= 12 weeks\n* Histologically or cytologically confirmed LA/mGC\n* HER2-positive tumor (primary tumor or metastatic lesion), defined as either IHC 3+ or IHC 2+ and ISH-positive\n* Inoperable LA/mGC\n\nExclusion Criteria:\n\nMetastatic Breast Cancer\n\n* Prior treatments before first study treatment:\n\n 1. Investigational therapy within 28 days or 5 half-lives, whichever is longer\n 2. Hormonal therapy within 14 days\n 3. Trastuzumab within 21 days\n* Prior treatment with trastuzumab emtansine or prior enrollment in a trastuzumab emtansine-containing study, regardless of whether the patient received trastuzumab emtansine\n* Prior treatment with capecitabine\n* History of severe or unexpected reactions to fluoropyrimidine or known hypersensitivity to fluorouracil\n* Related capecitabine contraindications\n\n 1. Treatment with sorivudine or chemically-related analogues\n 2. Rare hereditary problems of galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption\n 3. Complete absence of dihydropyrimidine dehydrogenase (DPD) activity\n* History of intolerance or hypersensitivity to trastuzumab or murine proteins or any product component\n* History of exposure to high cumulative doses of anthracyclines\n* Brain metastases that are symptomatic or require radiation, surgery, or steroid therapy to control symptoms within 28 days before study drug\n* Current peripheral neuropathy of Grade \\>/=3\n* History of other malignancy within the last 5 years, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, Stage I uterine cancer, or other cancers with a similar outcome\n* Current unstable ventricular arrhythmia requiring treatment\n* History of symptomatic congestive heart failure (CHF)\n* History of myocardial infarction or unstable angina within 6 months prior to study drug\n* History of left ventricular ejection fraction (LVEF) less than (\\<) 40% or symptomatic CHF with previous trastuzumab treatment\n* Severe dyspnea at rest due to complications of advanced malignancy or currently requiring continuous oxygen therapy\n* Clinically significant malabsorption syndrome or inability to take oral medication\n* Current severe, uncontrolled systemic disease (such as clinically significant cardiovascular, pulmonary, or metabolic disease)\n* Major surgical procedure or significant traumatic injury within 28 days before enrollment or anticipation of the need for major surgery during study treatment\n* Current known active infection with human immunodeficiency virus (HIV) or hepatitis B or C\n* Lapatinib within 14 days before study drug\n\nLocally Advanced/Metastatic Gastric Cancer\n\n* Same as above, with addition of previous chemotherapy for advanced/metastatic disease (prior adjuvant/neoadjuvant therapy is allowed if at least 6 months has elapsed between completion of adjuvant/neoadjuvant therapy and enrollment into the study)'}, 'identificationModule': {'nctId': 'NCT01702558', 'acronym': 'TRAXHER2', 'briefTitle': 'A Combination Study of Kadcyla (Trastuzumab Emtansine) and Capecitabine in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Metastatic Breast Cancer (mBC) or HER2-Positive Locally Advanced/Metastatic Gastric Cancer (LA/mGC)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': 'Phase I Study of the Combination of Trastuzumab Emtansine (T-DM1) and Capecitabine in HER2-Positive Metastatic Breast Cancer and HER2-Positive Locally Advanced/Metastatic Gastric Cancer Patients, Followed by a Randomized, Open-Label Phase II Study of Trastuzumab Emtansine and Capecitabine Versus Trastuzumab Emtansine Alone in HER2-Positive Metastatic Breast Cancer', 'orgStudyIdInfo': {'id': 'MO28230'}, 'secondaryIdInfos': [{'id': '2012-001547-46', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Phase 1 (mBC) Cohort 1: T-DM1 + Capecitabine', 'description': 'In Phase 1, Cohort 1 participants (with mBC) will receive trastuzumab emtansine (T-DM1) at a dose of 3.6 milligrams per kilogram (mg/kg) via intravenous (IV) infusion (on Day 1 \\[on Day 2 for Cycle 1\\] of each 21-day cycle) along with capecitabine at de-escalating dose levels (starting from 750 milligrams per meter squared \\[mg/m\\^2\\]) via tablet orally twice daily on Days 1-14 of each 21-day cycle until unacceptable toxicity, withdrawal of consent, disease progression (PD), death, or study end.', 'interventionNames': ['Drug: Capecitabine', 'Drug: Trastuzumab emtansine (T-DM1)']}, {'type': 'EXPERIMENTAL', 'label': 'Phase 1 (LA/mGC) Cohort 2: T-DM1 + Capecitabine', 'description': 'In Phase 1, Cohort 2 participants (with LA/mGC) will receive trastuzumab emtansine at a dose of 2.4 mg/kg via IV infusion on Day 1 (on Day 2 of first week) of every week along with capecitabine at MTD (determined in Cohort 1) via tablet orally twice daily on Days 1-14 followed by a 7-day rest period, in each 21-day cycle until unacceptable toxicity, withdrawal of consent, PD, death, or study end.', 'interventionNames': ['Drug: Trastuzumab emtansine (T-DM1)', 'Drug: Capecitabine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Phase 2 (mBC): T-DM1 + Capecitabine', 'description': 'In Phase 2, participants (with mBC) who will be randomized to this group, will receive trastuzumab emtansine at a dose of 3.6 mg/kg via IV infusion on Day 1 of each 21-day cycle along with capecitabine at MTD via tablet orally twice daily on Days 1-14 of each 21-day cycle until unacceptable toxicity, withdrawal of consent, PD, death, or study end.', 'interventionNames': ['Drug: Trastuzumab emtansine (T-DM1)', 'Drug: Capecitabine']}, {'type': 'EXPERIMENTAL', 'label': 'Phase 2 (mBC): T-DM1', 'description': 'In Phase 2, participants (with mBC) who will be randomized to this group, will receive trastuzumab emtansine at a dose of 3.6 mg/kg via IV infusion on Day 1 of each 21-day cycle until investigator-assessed PD, unacceptable toxicity, withdrawal of consent, death, or study end.', 'interventionNames': ['Drug: Trastuzumab emtansine (T-DM1)']}], 'interventions': [{'name': 'Capecitabine', 'type': 'DRUG', 'otherNames': ['Xeloda'], 'description': 'Capecitabine will be administered at de-escalating doses (starting from 750 mg/m\\^2) to determine the MTD.', 'armGroupLabels': ['Phase 1 (mBC) Cohort 1: T-DM1 + Capecitabine']}, {'name': 'Trastuzumab emtansine (T-DM1)', 'type': 'DRUG', 'otherNames': ['Kadcyla,', 'RO5304020'], 'description': 'Trastuzumab emtansine will be administered at a dose of 3.6 mg/kg via IV infusion every 3 weeks.', 'armGroupLabels': ['Phase 1 (mBC) Cohort 1: T-DM1 + Capecitabine', 'Phase 2 (mBC): T-DM1', 'Phase 2 (mBC): T-DM1 + Capecitabine']}, {'name': 'Trastuzumab emtansine (T-DM1)', 'type': 'DRUG', 'otherNames': ['Kadcyla,', 'RO5304020'], 'description': 'Trastuzumab emtansine will be administered at a dose of 2.4 mg/kg via IV infusion every week.', 'armGroupLabels': ['Phase 1 (LA/mGC) Cohort 2: T-DM1 + Capecitabine']}, {'name': 'Capecitabine', 'type': 'DRUG', 'otherNames': ['Xeloda'], 'description': 'Capecitabine will be administered at the MTD determined in Cohort 1.', 'armGroupLabels': ['Phase 1 (LA/mGC) Cohort 2: T-DM1 + Capecitabine', 'Phase 2 (mBC): T-DM1 + Capecitabine']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'C1025ABI', 'city': 'CABA', 'country': 'Argentina', 'facility': 'Fundacion Investigar'}, {'zip': 'F5300COE', 'city': 'La Rioja', 'country': 'Argentina', 'facility': 'Centro Oncologico Riojano Integral (CORI)', 'geoPoint': {'lat': -29.41328, 'lon': -66.85637}}, {'zip': '81520-060', 'city': 'Curitiba', 'state': 'Paraná', 'country': 'Brazil', 'facility': 'Hospital Erasto Gaertner', 'geoPoint': {'lat': -25.42778, 'lon': -49.27306}}, {'zip': '14025-270', 'city': 'Ribeirão Preto', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Instituto Oncologico de Ribeirao Preto - INORP', 'geoPoint': {'lat': -21.1775, 'lon': -47.81028}}, {'zip': '15090-000', 'city': 'São José do Rio Preto', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Faculdade de Medicina de Sao Jose do Rio Preto - FAMERP*X*', 'geoPoint': {'lat': -20.81972, 'lon': -49.37944}}, {'zip': '01246-000', 'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Instituto do Cancer do Estado de Sao Paulo - ICESP', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'zip': 'V5Z 4E6', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'British Columbia Cancer Agency (Bcca) - Vancouver Cancer Centre', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'zip': '49055', 'city': 'Angers', 'country': 'France', 'facility': 'ICO Paul Papin; Oncologie Medicale.', 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}, {'zip': '69373', 'city': 'Lyon', 'country': 'France', 'facility': 'Centre Leon Berard; Departement Oncologie Medicale', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '13273', 'city': 'Marseille', 'country': 'France', 'facility': 'Institut Paoli Calmettes; Oncologie Medicale', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '75231', 'city': 'Paris', 'country': 'France', 'facility': 'Institut Curie; Oncologie Medicale', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '44805', 'city': 'Saint-Herblain', 'country': 'France', 'facility': 'Ico Rene Gauducheau; Oncologie', 'geoPoint': {'lat': 47.21154, 'lon': -1.651}}, {'zip': '10117', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Charité-Universitätsm. 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