Ignite Creation Date:
2025-12-25 @ 4:42 AM
Ignite Modification Date:
2025-12-26 @ 3:43 AM
Study NCT ID:
NCT04740918
Status:
TERMINATED
Last Update Posted:
2025-08-08
First Post:
2021-02-03
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Study of Trastuzumab Emtansine in Combination With Atezolizumab or Placebo as a Treatment for Participants With Human Epidermal Growth Factor 2 (HER2)-Positive and Programmed Death-ligand 1 (PD-L1)-Positive Locally Advanced (LABC) or Metastatic Breast Cancer (MBC)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Egypt', 'Germany', 'Greece', 'Hungary', 'Slovenia'], 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2025-06-29', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000080044', 'term': 'Ado-Trastuzumab Emtansine'}, {'id': 'C000594389', 'term': 'atezolizumab'}], 'ancestors': [{'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 prematurely terminate the study due to a lower-than-expected enrollment rate.'}}, 'adverseEventsModule': {'timeFrame': 'Up to 28 months', 'description': 'Safety evaluable population included all participants who received at least one full or partial dose of study drug. One participant randomized to Trastuzumab Emtansine + Placebo moved to Trastuzumab Emtansine + Atezolizumab 1200 mg. Hence, has been represented in the later arm for safety analysis.', 'eventGroups': [{'id': 'EG000', 'title': 'Trastuzumab Emtansine 3.6 mg + Placebo', 'description': 'Participants received trastuzumab emtansine, 3.6 mg, Q3W as an IV infusion in combination with atezolizumab matching placebo, Q3W as an IV infusion on Day 1 of each 21-day cycle until radiographic disease progression, intolerable toxicity, withdrawal of consent, death or study termination by the sponsor.', 'otherNumAtRisk': 49, 'deathsNumAtRisk': 49, 'otherNumAffected': 46, 'seriousNumAtRisk': 49, 'deathsNumAffected': 3, 'seriousNumAffected': 9}, {'id': 'EG001', 'title': 'Trastuzumab Emtansine 3.6 mg + Atezolizumab 1200 mg', 'description': 'Participants received trastuzumab emtansine, 3.6 mg, Q3W as an IV infusion in combination with atezolizumab, 1200 mg, Q3W as an IV infusion on Day 1 of each 21-day cycle until radiographic disease progression, intolerable toxicity, withdrawal of consent, death or study termination by the sponsor.', 'otherNumAtRisk': 47, 'deathsNumAtRisk': 47, 'otherNumAffected': 46, 'seriousNumAtRisk': 47, 'deathsNumAffected': 6, 'seriousNumAffected': 14}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 19, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 36, 'numAffected': 20}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 6, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 3, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 8, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 6, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 21, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 20, 'numAffected': 12}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Hypothyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 9, 'numAffected': 7}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 6, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 14, 'numAffected': 11}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 15, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 18, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 30, 'numAffected': 16}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 16, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 17, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 7, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 9, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 15, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 16, 'numAffected': 11}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Influenza like illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 16, 'numAffected': 11}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 6, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Infusion related reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 25, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 52, 'numAffected': 23}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Amylase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 6, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 33, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 52, 'numAffected': 26}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Blood alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 9, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 19, 'numAffected': 11}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Blood bilirubin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 5, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 23, 'numAffected': 7}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Blood cholesterol increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 5, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Blood lactate dehydrogenase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 14, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 19, 'numAffected': 11}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Gamma-glutamyltransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 8, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 15, 'numAffected': 11}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Lipase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 8, 'numAffected': 6}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Lymphocyte count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 16, 'numAffected': 5}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 28, 'numAffected': 10}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 21, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 40, 'numAffected': 18}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'White blood cell count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 32, 'numAffected': 7}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 10, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Hyperphosphataemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Hypertriglyceridaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 5, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Hypoalbuminaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 15, 'numAffected': 7}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Hypocalcaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 9, 'numAffected': 5}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 40, 'numAffected': 14}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 15, 'numAffected': 6}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Hypophosphataemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 17, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 12, 'numAffected': 9}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Neuropathy peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 10, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 8, 'numAffected': 7}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}], 'seriousEvents': [{'term': 'Cardiac failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Gastrointestinal inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Biliary obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Hepatic function abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Peritonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Pneumonia viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Vascular device infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Humerus fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Infusion related reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 4, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Neuropathy peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Progression-Free Survival (PFS) as Determined by Investigator Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Trastuzumab Emtansine 3.6 mg + Placebo', 'description': 'Participants received trastuzumab emtansine, 3.6 mg, Q3W as an IV infusion in combination with atezolizumab matching placebo, Q3W as an IV infusion on Day 1 of each 21-day cycle until radiographic disease progression, intolerable toxicity, withdrawal of consent, death or study termination by the sponsor.'}, {'id': 'OG001', 'title': 'Trastuzumab Emtansine 3.6 mg + Atezolizumab 1200 mg', 'description': 'Participants received trastuzumab emtansine, 3.6 mg, Q3W as an IV infusion in combination with atezolizumab, 1200 mg, Q3W as an IV infusion on Day 1 of each 21-day cycle until radiographic disease progression, intolerable toxicity, withdrawal of consent, death or study termination by the sponsor.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.52', 'groupId': 'OG000', 'lowerLimit': '6.18', 'upperLimit': '10.94'}, {'value': '8.61', 'groupId': 'OG001', 'lowerLimit': '5.72', 'upperLimit': '16.92'}]}]}], 'analyses': [{'pValue': '0.2876', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.75', 'ciLowerLimit': '0.44', 'ciUpperLimit': '1.28', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Cox proportional hazards model, stratified by local hormonal status (estrogen receptors (ER) and/or progesterone receptor (PgR) positive vs. ER and PgR negative/unknown) and Disease status (visceral metastasis without brain metastasis vs. non-visceral metastasis only without brain metastasis \\[including locally advanced disease\\] vs. Brain metastasis) were used to estimate the Hazard Ratio (HR).'}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 28 months', 'description': 'PFS was defined as the time from randomization to the first occurrence of documented disease progression (PD), as determined by the investigator according to RECIST v1.1 or death from any cause whichever occurs first. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum in the study, including baseline, in addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeter (mm). Median PFS was calculated using the Kaplan-Meier (KM) methodology. Data for participants without PD or death from any cause as of the data cut-off date were censored at the time of the last tumor assessment.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all participants who were randomized in the study, whether they received any study medication.'}, {'type': 'PRIMARY', 'title': 'Overall Survival (OS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Trastuzumab Emtansine 3.6 mg + Placebo', 'description': 'Participants received trastuzumab emtansine, 3.6 mg, Q3W as an IV infusion in combination with atezolizumab matching placebo, Q3W as an IV infusion on Day 1 of each 21-day cycle until radiographic disease progression, intolerable toxicity, withdrawal of consent, death or study termination by the sponsor.'}, {'id': 'OG001', 'title': 'Trastuzumab Emtansine 3.6 mg + Atezolizumab 1200 mg', 'description': 'Participants received trastuzumab emtansine, 3.6 mg, Q3W as an IV infusion in combination with atezolizumab, 1200 mg, Q3W as an IV infusion on Day 1 of each 21-day cycle until radiographic disease progression, intolerable toxicity, withdrawal of consent, death or study termination by the sponsor.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'The median and 95% confidence interval (CI) was not estimable due to insufficient number of events.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'The median and upper limit of 95% CI was not estimable due to insufficient number of events.', 'groupId': 'OG001', 'lowerLimit': '21.29', 'upperLimit': 'NA'}]}]}], 'analyses': [{'pValue': '0.5151', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.59', 'ciLowerLimit': '0.39', 'ciUpperLimit': '6.43', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Cox proportional hazards model, stratified by local hormonal status (ER and/or PgR positive vs. ER and PgR negative/unknown) and Disease status (visceral metastasis without brain metastasis vs. non-visceral metastasis only without brain metastasis \\[including locally advanced disease\\] vs. Brain metastasis) were used to estimate the HR.'}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 28 months', 'description': 'OS was defined as the time from the first dose of study treatment to the time of death from any cause. Participants who are alive as of the data cut-off date of the analysis were censored at the last known date they were alive. Participants with no post-baseline information were censored at the date of randomization plus 1 day. Median OS was calculated using the KM methodology.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all participants who were randomized in the study, whether they received any study medication.'}, {'type': 'SECONDARY', 'title': 'Objective Response Rate (ORR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Trastuzumab Emtansine 3.6 mg + Placebo', 'description': 'Participants received trastuzumab emtansine, 3.6 mg, Q3W as an IV infusion in combination with atezolizumab matching placebo, Q3W as an IV infusion on Day 1 of each 21-day cycle until radiographic disease progression, intolerable toxicity, withdrawal of consent, death or study termination by the sponsor.'}, {'id': 'OG001', 'title': 'Trastuzumab Emtansine 3.6 mg + Atezolizumab 1200 mg', 'description': 'Participants received trastuzumab emtansine, 3.6 mg, Q3W as an IV infusion in combination with atezolizumab, 1200 mg, Q3W as an IV infusion on Day 1 of each 21-day cycle until radiographic disease progression, intolerable toxicity, withdrawal of consent, death or study termination by the sponsor.'}], 'classes': [{'categories': [{'measurements': [{'value': '49', 'groupId': 'OG000', 'lowerLimit': '34.64', 'upperLimit': '63.48'}, {'value': '53.3', 'groupId': 'OG001', 'lowerLimit': '38.04', 'upperLimit': '68.07'}]}]}], 'analyses': [{'pValue': '0.7240', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.16', 'ciLowerLimit': '0.50', 'ciUpperLimit': '2.70', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'A Cochran-Mantel-Haenszel chi-square test, stratified by local hormonal status (ER and/or PgR positive vs. ER and PgR negative/unknown) and Disease status (visceral metastasis without brain metastasis vs. non-visceral metastasis only without brain metastasis \\[including locally advanced disease\\] vs. Brain metastasis), was used to test for difference in response rates.'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 28 months', 'description': 'ORR was defined as the percentage of participants with complete response (CR) or partial response (PR) on two consecutive assessments, at least 28 days apart, as determined by the investigator using RECIST v.1.1. CR was defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) having a reduction in short axis to \\<10 mm. PR was defined as at least a 30% decrease in the sum of diameters (SOD) of target lesions, taking as reference the baseline SOD. Only participants with measurable disease at baseline were analyzed for this outcome measure. Participants without a post-baseline tumor assessment were considered non-responders. An estimate of the ORR and its 95% CI (Wilson score confidence interval) were calculated for each treatment arm.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Subset ITT with measurable disease included all participants in the ITT with a measurable disease at baseline. ITT population included all participants who were randomized to the study, whether or not they received any study medication.'}, {'type': 'SECONDARY', 'title': 'Duration of Response (DOR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Trastuzumab Emtansine 3.6 mg + Placebo', 'description': 'Participants received trastuzumab emtansine, 3.6 mg, Q3W as an IV infusion in combination with atezolizumab matching placebo, Q3W as an IV infusion on Day 1 of each 21-day cycle until radiographic disease progression, intolerable toxicity, withdrawal of consent, death or study termination by the sponsor.'}, {'id': 'OG001', 'title': 'Trastuzumab Emtansine 3.6 mg + Atezolizumab 1200 mg', 'description': 'Participants received trastuzumab emtansine, 3.6 mg, Q3W as an IV infusion in combination with atezolizumab, 1200 mg, Q3W as an IV infusion on Day 1 of each 21-day cycle until radiographic disease progression, intolerable toxicity, withdrawal of consent, death or study termination by the sponsor.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.21', 'comment': 'The upper limit of 95%CI was not estimable due to insufficient number of events.', 'groupId': 'OG000', 'lowerLimit': '5.72', 'upperLimit': 'NA'}, {'value': '15.57', 'comment': 'The upper limit of 95%CI was not estimable due to insufficient number of events.', 'groupId': 'OG001', 'lowerLimit': '7.06', 'upperLimit': 'NA'}]}]}], 'analyses': [{'pValue': '0.3531', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.65', 'ciLowerLimit': '0.26', 'ciUpperLimit': '1.61', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Cox proportional hazards model, stratified by local hormonal status (ER and/or PgR positive vs. ER and PgR negative/unknown) and Disease status (visceral metastasis without brain metastasis vs. non-visceral metastasis only without brain metastasis \\[including locally advanced disease\\] vs. Brain metastasis) were used to estimate the HR.'}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 28 months', 'description': 'DOR was calculated for participants who had a best OR of CR/PR. DOR was defined as time from first occurrence of a documented OR until the time of documented PD or death from any cause, whichever occurs first as determined by investigator assessment using RECIST v1.1. CR=the disappearance of all target lesions or any pathological lymph nodes (whether target or non-target) having a reduction in short axis to \\<10 mm. PR=at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD. PD=at least a 20% increase in the SOD of target lesions, taking as reference the smallest sum on the study including baseline (nadir). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Median DOR was calculated using the KM methodology.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Subset ITT with measurable disease included all participants in the ITT with a measurable disease at baseline. ITT population included all participants who were randomized to the study, whether or not they received any study medication. Overall number analyzed is the number of participants with OR, i.e, responders.'}, {'type': 'SECONDARY', 'title': 'PFS in Participants With Baseline Brain Metastases as Determined by Investigator Assessment Using RECIST v1.1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Trastuzumab Emtansine 3.6 mg + Placebo', 'description': 'Participants received trastuzumab emtansine, 3.6 mg, Q3W as an IV infusion in combination with atezolizumab matching placebo, Q3W as an IV infusion on Day 1 of each 21-day cycle until radiographic disease progression, intolerable toxicity, withdrawal of consent, death or study termination by the sponsor.'}, {'id': 'OG001', 'title': 'Trastuzumab Emtansine 3.6 mg + Atezolizumab 1200 mg', 'description': 'Participants received trastuzumab emtansine, 3.6 mg, Q3W as an IV infusion in combination with atezolizumab, 1200 mg, Q3W as an IV infusion on Day 1 of each 21-day cycle until radiographic disease progression, intolerable toxicity, withdrawal of consent, death or study termination by the sponsor.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.69', 'comment': 'The upper limit of 95% CI was not estimable due to insufficient number of events.', 'groupId': 'OG000', 'lowerLimit': '4.14', 'upperLimit': 'NA'}, {'value': '4.78', 'comment': 'The upper limit of 95% CI was not estimable due to insufficient number of events.', 'groupId': 'OG001', 'lowerLimit': '1.31', 'upperLimit': 'NA'}]}]}], 'analyses': [{'pValue': '0.7175', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.35', 'ciLowerLimit': '0.27', 'ciUpperLimit': '6.81', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Cox proportional hazards model, stratified by local hormonal status (ER and/or PgR positive vs. ER and PgR negative/unknown) and Disease status (visceral metastasis without brain metastasis vs. non-visceral metastasis only without brain metastasis \\[including locally advanced disease\\] vs. Brain metastasis) were used to estimate the HR.'}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 28 months', 'description': 'PFS was defined as the time from randomization to the first occurrence of documented PD, as determined by the investigator according to RECIST v1.1 or death from any cause whichever occurs first. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum in the study, including baseline, in addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Median PFS was calculated using the KM methodology.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT with brain metastasis population included all participants in ITT with brain metastasis at randomization.'}, {'type': 'SECONDARY', 'title': 'OS in Participants With Baseline Brain Metastases', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Trastuzumab Emtansine 3.6 mg + Placebo', 'description': 'Participants received trastuzumab emtansine, 3.6 mg, Q3W as an IV infusion in combination with atezolizumab matching placebo, Q3W as an IV infusion on Day 1 of each 21-day cycle until radiographic disease progression, intolerable toxicity, withdrawal of consent, death or study termination by the sponsor.'}, {'id': 'OG001', 'title': 'Trastuzumab Emtansine 3.6 mg + Atezolizumab 1200 mg', 'description': 'Participants received trastuzumab emtansine, 3.6 mg, Q3W as an IV infusion in combination with atezolizumab, 1200 mg, Q3W as an IV infusion on Day 1 of each 21-day cycle until radiographic disease progression, intolerable toxicity, withdrawal of consent, death or study termination by the sponsor.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'The median and 95%CI was not estimable due to insufficient number of events.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'The median and upper limit of 95%CI was not estimable due to insufficient number of events.', 'groupId': 'OG001', 'lowerLimit': '9.53', 'upperLimit': 'NA'}]}]}], 'analyses': [{'pValue': '0.3173', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Cox proportional hazards model, stratified by local hormonal status (ER and/or PgR positive vs. ER and PgR negative/unknown) and Disease status (visceral metastasis without brain metastasis vs. non-visceral metastasis only without brain metastasis \\[including locally advanced disease\\] vs. Brain metastasis) were used to estimate the HR.'}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 28 months', 'description': 'OS is defined as the time from the first dose of study treatment to the time of death from any cause. Median OS was calculated using the KM methodology.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT with brain metastasis population included all participants in ITT with brain metastasis at randomization.'}, {'type': 'SECONDARY', 'title': 'Central Nervous System (CNS) PFS as Determined by Investigator Using RECIST v1.1 in Participants With Baseline CNS Metastases', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Trastuzumab Emtansine 3.6 mg + Placebo', 'description': 'Participants received trastuzumab emtansine, 3.6 mg, Q3W as an IV infusion in combination with atezolizumab matching placebo, Q3W as an IV infusion on Day 1 of each 21-day cycle until radiographic disease progression, intolerable toxicity, withdrawal of consent, death or study termination by the sponsor.'}, {'id': 'OG001', 'title': 'Trastuzumab Emtansine 3.6 mg + Atezolizumab 1200 mg', 'description': 'Participants received trastuzumab emtansine, 3.6 mg, Q3W as an IV infusion in combination with atezolizumab, 1200 mg, Q3W as an IV infusion on Day 1 of each 21-day cycle until radiographic disease progression, intolerable toxicity, withdrawal of consent, death or study termination by the sponsor.'}], 'classes': [{'categories': [{'measurements': [{'value': '10.41', 'comment': 'The upper limit of 95% CI was not estimable due to insufficient number of events.', 'groupId': 'OG000', 'lowerLimit': '4.11', 'upperLimit': 'NA'}, {'value': '9.53', 'comment': 'The upper limit of 95% CI was not estimable due to insufficient number of events.', 'groupId': 'OG001', 'lowerLimit': '1.31', 'upperLimit': 'NA'}]}]}], 'analyses': [{'pValue': '0.8658', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.19', 'ciLowerLimit': '0.16', 'ciUpperLimit': '8.60', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Cox proportional hazards model, stratified by local hormonal status (ER and/or PgR positive vs. ER and PgR negative/unknown) and Disease status (visceral metastasis without brain metastasis vs. non-visceral metastasis only without brain metastasis \\[including locally advanced disease\\] vs. Brain metastasis) were used to estimate the HR.'}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 28 months', 'description': 'CNS PFS was defined as the time from randomization to the first occurrence of documented CNS PD, or first occurrence of symptomatic CNS disease as determined by the investigator according to RECIST v1.1 or death from any cause whichever occurs first. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum in the study, including baseline, in addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Median PFS was calculated using the KM methodology. Participants who experienced non-CNS PD at the time of analysis were censored at the date of this progression. Participants who experienced no PD and were alive at the time of analysis were censored at date of their last post-baseline tumor assessment or, if they had no post-baseline tumor assessment, on the date of randomization + 1 day.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT with CNS metastasis population included all participants in ITT with CNS metastasis at randomization.'}, {'type': 'SECONDARY', 'title': 'CNS PFS as Determined by Investigator Using RECIST v1.1 in Participants Without Baseline CNS Metastases', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Trastuzumab Emtansine 3.6 mg + Placebo', 'description': 'Participants received trastuzumab emtansine, 3.6 mg, Q3W as an IV infusion in combination with atezolizumab matching placebo, Q3W as an IV infusion on Day 1 of each 21-day cycle until radiographic disease progression, intolerable toxicity, withdrawal of consent, death or study termination by the sponsor.'}, {'id': 'OG001', 'title': 'Trastuzumab Emtansine 3.6 mg + Atezolizumab 1200 mg', 'description': 'Participants received trastuzumab emtansine, 3.6 mg, Q3W as an IV infusion in combination with atezolizumab, 1200 mg, Q3W as an IV infusion on Day 1 of each 21-day cycle until radiographic disease progression, intolerable toxicity, withdrawal of consent, death or study termination by the sponsor.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'The median and 95% CI were not estimable due to insufficient number of events.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'The median and upper limit of 95% CI were not estimable due to insufficient number of events.', 'groupId': 'OG001', 'lowerLimit': '21.29', 'upperLimit': 'NA'}]}]}], 'analyses': [{'pValue': '0.8407', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.16', 'ciLowerLimit': '0.27', 'ciUpperLimit': '4.99', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Cox proportional hazards model, stratified by local hormonal status (ER and/or PgR positive vs. ER and PgR negative/unknown) and Disease status (visceral metastasis without brain metastasis vs. non-visceral metastasis only without brain metastasis \\[including locally advanced disease\\] vs. Brain metastasis) were used to estimate the HR.'}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 28 months', 'description': 'CNS PFS was defined as the time from randomization to the first occurrence of documented CNS PD, or first occurrence of symptomatic CNS disease as determined by the investigator according to RECIST v1.1 or death from any cause whichever occurs first. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum in the study, including baseline, in addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Median PFS was calculated using the KM methodology. Participants who experienced non-CNS PD at the time of analysis were censored at the date of this progression. Participants who experienced no PD and were alive at the time of analysis were censored at date of their last post-baseline tumor assessment or, if they had no post-baseline tumor assessment, on the date of randomization + 1 day.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT without CNS metastases at baseline population included all participants in the ITT without CNS metastasis at baseline.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Trastuzumab Emtansine 3.6 mg + Placebo', 'description': 'Participants received trastuzumab emtansine, 3.6 mg, Q3W as an IV infusion in combination with atezolizumab matching placebo, Q3W as an IV infusion on Day 1 of each 21-day cycle until radiographic disease progression, intolerable toxicity, withdrawal of consent, death or study termination by the sponsor.'}, {'id': 'OG001', 'title': 'Trastuzumab Emtansine 3.6 mg + Atezolizumab 1200 mg', 'description': 'Participants received trastuzumab emtansine, 3.6 mg, Q3W as an IV infusion in combination with atezolizumab, 1200 mg, Q3W as an IV infusion on Day 1 of each 21-day cycle until radiographic disease progression, intolerable toxicity, withdrawal of consent, death or study termination by the sponsor.'}], 'classes': [{'categories': [{'measurements': [{'value': '93.9', 'groupId': 'OG000'}, {'value': '97.9', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 28 months', 'description': 'An AE was any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including abnormal laboratory values or abnormal clinical test results), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety evaluable population included all participants who received at least one full or partial dose of study drug. One participant randomized to Trastuzumab Emtansine + Placebo moved to Trastuzumab Emtansine + Atezolizumab 1200 mg. Hence, has been represented in the later arm for safety analysis.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'PFS as Determined by a Blinded Independent Central Review (BICR) Committee Using RECIST v1.1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Trastuzumab Emtansine 3.6 mg + Placebo', 'description': 'Participants received trastuzumab emtansine, 3.6 mg, Q3W as an IV infusion in combination with atezolizumab matching placebo, Q3W as an IV infusion on Day 1 of each 21-day cycle until radiographic disease progression, intolerable toxicity, withdrawal of consent, death or study termination by the sponsor.'}, {'id': 'OG001', 'title': 'Trastuzumab Emtansine 3.6 mg + Atezolizumab 1200 mg', 'description': 'Participants received trastuzumab emtansine, 3.6 mg, Q3W as an IV infusion in combination with atezolizumab, 1200 mg, Q3W as an IV infusion on Day 1 of each 21-day cycle until radiographic disease progression, intolerable toxicity, withdrawal of consent, death or study termination by the sponsor.'}], 'timeFrame': 'Up to 28 months', 'description': 'PFS was defined as the time from randomization to the first occurrence of documented PD, as determined by the BICR committee according to RECIST v1.1 or death from any cause whichever occurs first. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum in the study, including baseline, in addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.', 'reportingStatus': 'POSTED', 'populationDescription': "As prespecified in the latest protocol, following sponsor's decision to prematurely terminate the study, analysis of PFS as determined by a BICR committee was not conducted."}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Mean Absolute Scores in Physical Function (PF), Role Function (RF) and Global Health Status (GHS/QoL) Scores Measured Using European Organization for Research and Treatment of Cancer (EORTC QLQ-C30)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Trastuzumab Emtansine 3.6 mg + Placebo', 'description': 'Participants received trastuzumab emtansine, 3.6 mg, Q3W as an IV infusion in combination with atezolizumab matching placebo, Q3W as an IV infusion on Day 1 of each 21-day cycle until radiographic disease progression, intolerable toxicity, withdrawal of consent, death or study termination by the sponsor.'}, {'id': 'OG001', 'title': 'Trastuzumab Emtansine 3.6 mg + Atezolizumab 1200 mg', 'description': 'Participants received trastuzumab emtansine, 3.6 mg, Q3W as an IV infusion in combination with atezolizumab, 1200 mg, Q3W as an IV infusion on Day 1 of each 21-day cycle until radiographic disease progression, intolerable toxicity, withdrawal of consent, death or study termination by the sponsor.'}], 'timeFrame': 'Up to 28 months', 'description': "EORTC QLQ-C30 consists of 30 questions that assess five aspects of participant functioning (physical, emotional, role, cognitive, and social), three symptom scales (fatigue, nausea and vomiting, pain), GHS/QoL, and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). The PF scale has 5 questions about participant's PF and daily activities (strenuous activities, long walks, short walks, bed/chair rest \\& needing help with eating, dressing, washing themselves, or using the toilet). The RF scale has 2 questions about work/daily activities and hobbies/leisurely activities. The PF and RF are scored on a 4-point scale (1=Not at All to 4=Very Much). The GHS/QoL are scored on a 7-point scale (1=Very Poor to 7=Excellent). The obtained scores are linearly transformed to a score range of 0-100, where higher scores indicate a higher response level and better QoL, functioning/support.", 'reportingStatus': 'POSTED', 'populationDescription': "As prespecified in the latest protocol, following sponsor's decision to prematurely terminate the study, the analysis for EORTC QLQ-C30 was not conducted."}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change From-Baseline in PF, RF and GHS/QoL Scores Measured Using EORTC QLQ-C30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Trastuzumab Emtansine 3.6 mg + Placebo', 'description': 'Participants received trastuzumab emtansine, 3.6 mg, Q3W as an IV infusion in combination with atezolizumab matching placebo, Q3W as an IV infusion on Day 1 of each 21-day cycle until radiographic disease progression, intolerable toxicity, withdrawal of consent, death or study termination by the sponsor.'}, {'id': 'OG001', 'title': 'Trastuzumab Emtansine 3.6 mg + Atezolizumab 1200 mg', 'description': 'Participants received trastuzumab emtansine, 3.6 mg, Q3W as an IV infusion in combination with atezolizumab, 1200 mg, Q3W as an IV infusion on Day 1 of each 21-day cycle until radiographic disease progression, intolerable toxicity, withdrawal of consent, death or study termination by the sponsor.'}], 'timeFrame': 'Up to 28 months', 'description': "EORTC QLQ-C30 consists of 30 questions that assess five aspects of participant functioning (physical, emotional, role, cognitive, and social), three symptom scales (fatigue, nausea and vomiting, pain), GHS/QoL, and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). The PF scale has 5 questions about participant's PF and daily activities (strenuous activities, long walks, short walks, bed/chair rest \\& needing help with eating, dressing, washing themselves, or using the toilet). The RF scale has 2 questions about work/daily activities and hobbies/leisurely activities. The PF and RF are scored on a 4-point scale (1=Not at All to 4=Very Much). The GHS/QoL are scored on a 7-point scale (1=Very Poor to 7=Excellent). The obtained scores are linearly transformed to a score range of 0-100, where higher scores indicate a higher response level and better QoL, functioning/support.", 'reportingStatus': 'POSTED', 'populationDescription': "As prespecified in the latest protocol, following sponsor's decision to prematurely terminate the study, the analysis for EORTC QLQ-C30 was not conducted."}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percentage of Participants With Clinically Meaningful Deterioration in PF, RF and GHS/QoL Measured Using EORTC QLQ-C30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Trastuzumab Emtansine 3.6 mg + Placebo', 'description': 'Participants received trastuzumab emtansine, 3.6 mg, Q3W as an IV infusion in combination with atezolizumab matching placebo, Q3W as an IV infusion on Day 1 of each 21-day cycle until radiographic disease progression, intolerable toxicity, withdrawal of consent, death or study termination by the sponsor.'}, {'id': 'OG001', 'title': 'Trastuzumab Emtansine 3.6 mg + Atezolizumab 1200 mg', 'description': 'Participants received trastuzumab emtansine, 3.6 mg, Q3W as an IV infusion in combination with atezolizumab, 1200 mg, Q3W as an IV infusion on Day 1 of each 21-day cycle until radiographic disease progression, intolerable toxicity, withdrawal of consent, death or study termination by the sponsor.'}], 'timeFrame': 'Up to 28 months', 'description': "EORTC QLQ-C30 consists of 30 questions that assess five aspects of participant functioning (physical, emotional, role, cognitive, and social), three symptom scales (fatigue, nausea and vomiting, pain), GHS/QoL, and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). The PF scale has 5 questions about participant's PF and daily activities (strenuous activities, long walks, short walks, bed/chair rest \\& needing help with eating, dressing, washing themselves, or using the toilet). The RF scale has 2 questions about work/daily activities and hobbies/leisurely activities. The PF and RF are scored on a 4-point scale (1=Not at All to 4=Very Much). The GHS/QoL are scored on a 7-point scale (1=Very Poor to 7=Excellent). The obtained scores are linearly transformed to a score range of 0-100, where higher scores indicate a higher response level and better QoL, functioning/support.", 'reportingStatus': 'POSTED', 'populationDescription': "As prespecified in the latest protocol, following sponsor's decision to prematurely terminate the study, the analysis for EORTC QLQ-C30 was not conducted."}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Maximum Serum Concentration (Cmax) of Trastuzumab Emtansine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Trastuzumab Emtansine 3.6 mg + Placebo', 'description': 'Participants received trastuzumab emtansine, 3.6 mg, Q3W as an IV infusion in combination with atezolizumab matching placebo, Q3W as an IV infusion on Day 1 of each 21-day cycle until radiographic disease progression, intolerable toxicity, withdrawal of consent, death or study termination by the sponsor.'}, {'id': 'OG001', 'title': 'Trastuzumab Emtansine 3.6 mg + Atezolizumab 1200 mg', 'description': 'Participants received trastuzumab emtansine, 3.6 mg, Q3W as an IV infusion in combination with atezolizumab, 1200 mg, Q3W as an IV infusion on Day 1 of each 21-day cycle until radiographic disease progression, intolerable toxicity, withdrawal of consent, death or study termination by the sponsor.'}], 'timeFrame': 'Up to 28 months', 'description': "As prespecified in the latest protocol, following sponsor's decision to prematurely terminate the study, PK objectives and outcome measures were no longer applicable. Hence sample collection was stopped, and this outcome measure was not assessed or analyzed.", 'reportingStatus': 'POSTED', 'populationDescription': "As prespecified in the latest protocol, following sponsor's decision to prematurely terminate the study, PK objectives and outcome measures were no longer applicable. Hence sample collection was stopped, and this outcome measure was not assessed or analyzed."}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Cmax of Atezolizumab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Trastuzumab Emtansine 3.6 mg + Placebo', 'description': 'Participants received trastuzumab emtansine, 3.6 mg, Q3W as an IV infusion in combination with atezolizumab matching placebo, Q3W as an IV infusion on Day 1 of each 21-day cycle until radiographic disease progression, intolerable toxicity, withdrawal of consent, death or study termination by the sponsor.'}, {'id': 'OG001', 'title': 'Trastuzumab Emtansine 3.6 mg + Atezolizumab 1200 mg', 'description': 'Participants received trastuzumab emtansine, 3.6 mg, Q3W as an IV infusion in combination with atezolizumab, 1200 mg, Q3W as an IV infusion on Day 1 of each 21-day cycle until radiographic disease progression, intolerable toxicity, withdrawal of consent, death or study termination by the sponsor.'}], 'timeFrame': 'Up to 28 months', 'description': "As prespecified in the latest protocol, following sponsor's decision to prematurely terminate the study, PK objectives and outcome measures were no longer applicable. Hence sample collection was stopped, and this outcome measure was not assessed or analyzed.", 'reportingStatus': 'POSTED', 'populationDescription': "As prespecified in the latest protocol, following sponsor's decision to prematurely terminate the study, PK objectives and outcome measures were no longer applicable. Hence sample collection was stopped, and this outcome measure was not assessed or analyzed."}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percentage of Participants With Anti-Drug Antibodies (ADAs) to Trastuzumab Emtansine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Trastuzumab Emtansine 3.6 mg + Placebo', 'description': 'Participants received trastuzumab emtansine, 3.6 mg, Q3W as an IV infusion in combination with atezolizumab matching placebo, Q3W as an IV infusion on Day 1 of each 21-day cycle until radiographic disease progression, intolerable toxicity, withdrawal of consent, death or study termination by the sponsor.'}, {'id': 'OG001', 'title': 'Trastuzumab Emtansine 3.6 mg + Atezolizumab 1200 mg', 'description': 'Participants received trastuzumab emtansine, 3.6 mg, Q3W as an IV infusion in combination with atezolizumab, 1200 mg, Q3W as an IV infusion on Day 1 of each 21-day cycle until radiographic disease progression, intolerable toxicity, withdrawal of consent, death or study termination by the sponsor.'}], 'timeFrame': 'Up to 28 months', 'description': "As prespecified in the latest protocol, following sponsor's decision to prematurely terminate the study, immunogenicity objectives and outcome measures were no longer applicable.", 'reportingStatus': 'POSTED', 'populationDescription': "As prespecified in the latest protocol, following sponsor's decision to prematurely terminate the study, immunogenicity objectives and outcome measures were no longer applicable."}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percentage of Participants With ADAs to Atezolizumab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Trastuzumab Emtansine 3.6 mg + Placebo', 'description': 'Participants received trastuzumab emtansine, 3.6 mg, Q3W as an IV infusion in combination with atezolizumab matching placebo, Q3W as an IV infusion on Day 1 of each 21-day cycle until radiographic disease progression, intolerable toxicity, withdrawal of consent, death or study termination by the sponsor.'}, {'id': 'OG001', 'title': 'Trastuzumab Emtansine 3.6 mg + Atezolizumab 1200 mg', 'description': 'Participants received trastuzumab emtansine, 3.6 mg, Q3W as an IV infusion in combination with atezolizumab, 1200 mg, Q3W as an IV infusion on Day 1 of each 21-day cycle until radiographic disease progression, intolerable toxicity, withdrawal of consent, death or study termination by the sponsor.'}], 'timeFrame': 'Up to 28 months', 'description': "As prespecified in the latest protocol, following sponsor's decision to prematurely terminate the study, immunogenicity objectives and outcome measures were no longer applicable.", 'reportingStatus': 'POSTED', 'populationDescription': "As prespecified in the latest protocol, following sponsor's decision to prematurely terminate the study, immunogenicity objectives and outcome measures were no longer applicable."}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Trastuzumab Emtansine 3.6 mg + Placebo', 'description': 'Participants received trastuzumab emtansine, 3.6 milligrams (mg), every 3 weeks (Q3W) as an intravenous (IV) infusion in combination with atezolizumab matching placebo, Q3W as an IV infusion on Day 1 of each 21-day cycle until radiographic disease progression, intolerable toxicity, withdrawal of consent, death or study termination by the sponsor.'}, {'id': 'FG001', 'title': 'Trastuzumab Emtansine 3.6 mg + Atezolizumab 1200 mg', 'description': 'Participants received trastuzumab emtansine, 3.6 mg, Q3W as an IV infusion in combination with atezolizumab, 1200 mg, Q3W as an IV infusion on Day 1 of each 21-day cycle until radiographic disease progression, intolerable toxicity, withdrawal of consent, death or study termination by the sponsor.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '50'}, {'groupId': 'FG001', 'numSubjects': '46'}]}, {'type': 'Safety Population', 'comment': 'Safety evaluable population included all participants who received at least one full or partial dose of study drug. 1 participant randomized to Trastuzumab Emtansine + Placebo moved to Trastuzumab Emtansine + Atezolizumab 1200 mg. Hence, has been represented in the later arm for safety analysis.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '49'}, {'groupId': 'FG001', 'numSubjects': '47'}]}, {'type': 'ITT With Brain Metastases', 'comment': 'ITT with brain metastasis population included all participants in ITT with brain metastasis at randomization.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'ITT With CNS Metastases', 'comment': 'ITT with CNS metastasis population included all participants in ITT with CNS metastasis at randomization.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'ITT Without CNS Metastases', 'comment': 'ITT without CNS metastases population included all participants in the ITT without CNS metastasis at baseline.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '43'}, {'groupId': 'FG001', 'numSubjects': '42'}]}, {'type': 'ITT With Measurable Disease', 'comment': 'ITT with measurable disease population included all participants in the ITT without CNS metastasis at baseline.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '49'}, {'groupId': 'FG001', 'numSubjects': '45'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '50'}, {'groupId': 'FG001', 'numSubjects': '46'}]}], 'dropWithdraws': [{'type': 'Study Terminated by Sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '41'}, {'groupId': 'FG001', 'numSubjects': '32'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Progressive disease', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'A total of 96 participants with human epidermal growth factor receptor 2 (HER2)-positive and programmed death-ligand 1 (PD-L1)-positive locally advanced (LABC) or metastatic breast cancer (MBC) took part in the study across 52 investigative sites in 19 countries from 07 June 2021 to 19 June 2024.', 'preAssignmentDetails': 'Participants were randomized in 1:1 ratio to receive trastuzumab emtansine + placebo or trastuzumab emtansine + atezolizumab.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '96', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Trastuzumab Emtansine 3.6 mg + Placebo', 'description': 'Participants received trastuzumab emtansine, 3.6 mg, Q3W as an IV infusion in combination with atezolizumab matching placebo, Q3W as an IV infusion on Day 1 of each 21-day cycle until radiographic disease progression, intolerable toxicity, withdrawal of consent, death or study termination by the sponsor.'}, {'id': 'BG001', 'title': 'Trastuzumab Emtansine 3.6 mg + Atezolizumab 1200 mg', 'description': 'Participants received trastuzumab emtansine, 3.6 mg, Q3W as an IV infusion in combination with atezolizumab, 1200 mg, Q3W as an IV infusion on Day 1 of each 21-day cycle until radiographic disease progression, intolerable toxicity, withdrawal of consent, death or study termination by the sponsor.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '53.2', 'spread': '11.7', 'groupId': 'BG000'}, {'value': '50.9', 'spread': '10.0', 'groupId': 'BG001'}, {'value': '52.1', 'spread': '10.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '96', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '42', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '81', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Intent to Treat (ITT) population included all participants who were randomized in the study, whether or not they received any study medication.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-03-02', 'size': 4171164, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-06-12T16:13', 'hasProtocol': True}, {'date': '2023-03-28', 'size': 823113, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-06-12T16:13', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 96}}, 'statusModule': {'whyStopped': 'Due to low enrollment, the Sponsor decided to prematurely terminate the study', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2021-06-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2024-06-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-22', 'studyFirstSubmitDate': '2021-02-03', 'resultsFirstSubmitDate': '2025-06-12', 'studyFirstSubmitQcDate': '2021-02-03', 'lastUpdatePostDateStruct': {'date': '2025-08-08', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-07-22', 'studyFirstPostDateStruct': {'date': '2021-02-05', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-08-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'PFS as Determined by a Blinded Independent Central Review (BICR) Committee Using RECIST v1.1', 'timeFrame': 'Up to 28 months', 'description': 'PFS was defined as the time from randomization to the first occurrence of documented PD, as determined by the BICR committee according to RECIST v1.1 or death from any cause whichever occurs first. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum in the study, including baseline, in addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.'}, {'measure': 'Mean Absolute Scores in Physical Function (PF), Role Function (RF) and Global Health Status (GHS/QoL) Scores Measured Using European Organization for Research and Treatment of Cancer (EORTC QLQ-C30)', 'timeFrame': 'Up to 28 months', 'description': "EORTC QLQ-C30 consists of 30 questions that assess five aspects of participant functioning (physical, emotional, role, cognitive, and social), three symptom scales (fatigue, nausea and vomiting, pain), GHS/QoL, and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). The PF scale has 5 questions about participant's PF and daily activities (strenuous activities, long walks, short walks, bed/chair rest \\& needing help with eating, dressing, washing themselves, or using the toilet). The RF scale has 2 questions about work/daily activities and hobbies/leisurely activities. The PF and RF are scored on a 4-point scale (1=Not at All to 4=Very Much). The GHS/QoL are scored on a 7-point scale (1=Very Poor to 7=Excellent). The obtained scores are linearly transformed to a score range of 0-100, where higher scores indicate a higher response level and better QoL, functioning/support."}, {'measure': 'Change From-Baseline in PF, RF and GHS/QoL Scores Measured Using EORTC QLQ-C30', 'timeFrame': 'Up to 28 months', 'description': "EORTC QLQ-C30 consists of 30 questions that assess five aspects of participant functioning (physical, emotional, role, cognitive, and social), three symptom scales (fatigue, nausea and vomiting, pain), GHS/QoL, and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). The PF scale has 5 questions about participant's PF and daily activities (strenuous activities, long walks, short walks, bed/chair rest \\& needing help with eating, dressing, washing themselves, or using the toilet). The RF scale has 2 questions about work/daily activities and hobbies/leisurely activities. The PF and RF are scored on a 4-point scale (1=Not at All to 4=Very Much). The GHS/QoL are scored on a 7-point scale (1=Very Poor to 7=Excellent). The obtained scores are linearly transformed to a score range of 0-100, where higher scores indicate a higher response level and better QoL, functioning/support."}, {'measure': 'Percentage of Participants With Clinically Meaningful Deterioration in PF, RF and GHS/QoL Measured Using EORTC QLQ-C30', 'timeFrame': 'Up to 28 months', 'description': "EORTC QLQ-C30 consists of 30 questions that assess five aspects of participant functioning (physical, emotional, role, cognitive, and social), three symptom scales (fatigue, nausea and vomiting, pain), GHS/QoL, and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). The PF scale has 5 questions about participant's PF and daily activities (strenuous activities, long walks, short walks, bed/chair rest \\& needing help with eating, dressing, washing themselves, or using the toilet). The RF scale has 2 questions about work/daily activities and hobbies/leisurely activities. The PF and RF are scored on a 4-point scale (1=Not at All to 4=Very Much). The GHS/QoL are scored on a 7-point scale (1=Very Poor to 7=Excellent). The obtained scores are linearly transformed to a score range of 0-100, where higher scores indicate a higher response level and better QoL, functioning/support."}, {'measure': 'Maximum Serum Concentration (Cmax) of Trastuzumab Emtansine', 'timeFrame': 'Up to 28 months', 'description': "As prespecified in the latest protocol, following sponsor's decision to prematurely terminate the study, PK objectives and outcome measures were no longer applicable. Hence sample collection was stopped, and this outcome measure was not assessed or analyzed."}, {'measure': 'Cmax of Atezolizumab', 'timeFrame': 'Up to 28 months', 'description': "As prespecified in the latest protocol, following sponsor's decision to prematurely terminate the study, PK objectives and outcome measures were no longer applicable. Hence sample collection was stopped, and this outcome measure was not assessed or analyzed."}, {'measure': 'Percentage of Participants With Anti-Drug Antibodies (ADAs) to Trastuzumab Emtansine', 'timeFrame': 'Up to 28 months', 'description': "As prespecified in the latest protocol, following sponsor's decision to prematurely terminate the study, immunogenicity objectives and outcome measures were no longer applicable."}, {'measure': 'Percentage of Participants With ADAs to Atezolizumab', 'timeFrame': 'Up to 28 months', 'description': "As prespecified in the latest protocol, following sponsor's decision to prematurely terminate the study, immunogenicity objectives and outcome measures were no longer applicable."}], 'primaryOutcomes': [{'measure': 'Progression-Free Survival (PFS) as Determined by Investigator Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)', 'timeFrame': 'Up to 28 months', 'description': 'PFS was defined as the time from randomization to the first occurrence of documented disease progression (PD), as determined by the investigator according to RECIST v1.1 or death from any cause whichever occurs first. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum in the study, including baseline, in addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeter (mm). Median PFS was calculated using the Kaplan-Meier (KM) methodology. Data for participants without PD or death from any cause as of the data cut-off date were censored at the time of the last tumor assessment.'}, {'measure': 'Overall Survival (OS)', 'timeFrame': 'Up to 28 months', 'description': 'OS was defined as the time from the first dose of study treatment to the time of death from any cause. Participants who are alive as of the data cut-off date of the analysis were censored at the last known date they were alive. Participants with no post-baseline information were censored at the date of randomization plus 1 day. Median OS was calculated using the KM methodology.'}], 'secondaryOutcomes': [{'measure': 'Objective Response Rate (ORR)', 'timeFrame': 'Up to 28 months', 'description': 'ORR was defined as the percentage of participants with complete response (CR) or partial response (PR) on two consecutive assessments, at least 28 days apart, as determined by the investigator using RECIST v.1.1. CR was defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) having a reduction in short axis to \\<10 mm. PR was defined as at least a 30% decrease in the sum of diameters (SOD) of target lesions, taking as reference the baseline SOD. Only participants with measurable disease at baseline were analyzed for this outcome measure. Participants without a post-baseline tumor assessment were considered non-responders. An estimate of the ORR and its 95% CI (Wilson score confidence interval) were calculated for each treatment arm.'}, {'measure': 'Duration of Response (DOR)', 'timeFrame': 'Up to 28 months', 'description': 'DOR was calculated for participants who had a best OR of CR/PR. DOR was defined as time from first occurrence of a documented OR until the time of documented PD or death from any cause, whichever occurs first as determined by investigator assessment using RECIST v1.1. CR=the disappearance of all target lesions or any pathological lymph nodes (whether target or non-target) having a reduction in short axis to \\<10 mm. PR=at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD. PD=at least a 20% increase in the SOD of target lesions, taking as reference the smallest sum on the study including baseline (nadir). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Median DOR was calculated using the KM methodology.'}, {'measure': 'PFS in Participants With Baseline Brain Metastases as Determined by Investigator Assessment Using RECIST v1.1', 'timeFrame': 'Up to 28 months', 'description': 'PFS was defined as the time from randomization to the first occurrence of documented PD, as determined by the investigator according to RECIST v1.1 or death from any cause whichever occurs first. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum in the study, including baseline, in addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Median PFS was calculated using the KM methodology.'}, {'measure': 'OS in Participants With Baseline Brain Metastases', 'timeFrame': 'Up to 28 months', 'description': 'OS is defined as the time from the first dose of study treatment to the time of death from any cause. Median OS was calculated using the KM methodology.'}, {'measure': 'Central Nervous System (CNS) PFS as Determined by Investigator Using RECIST v1.1 in Participants With Baseline CNS Metastases', 'timeFrame': 'Up to 28 months', 'description': 'CNS PFS was defined as the time from randomization to the first occurrence of documented CNS PD, or first occurrence of symptomatic CNS disease as determined by the investigator according to RECIST v1.1 or death from any cause whichever occurs first. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum in the study, including baseline, in addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Median PFS was calculated using the KM methodology. Participants who experienced non-CNS PD at the time of analysis were censored at the date of this progression. Participants who experienced no PD and were alive at the time of analysis were censored at date of their last post-baseline tumor assessment or, if they had no post-baseline tumor assessment, on the date of randomization + 1 day.'}, {'measure': 'CNS PFS as Determined by Investigator Using RECIST v1.1 in Participants Without Baseline CNS Metastases', 'timeFrame': 'Up to 28 months', 'description': 'CNS PFS was defined as the time from randomization to the first occurrence of documented CNS PD, or first occurrence of symptomatic CNS disease as determined by the investigator according to RECIST v1.1 or death from any cause whichever occurs first. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum in the study, including baseline, in addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Median PFS was calculated using the KM methodology. Participants who experienced non-CNS PD at the time of analysis were censored at the date of this progression. Participants who experienced no PD and were alive at the time of analysis were censored at date of their last post-baseline tumor assessment or, if they had no post-baseline tumor assessment, on the date of randomization + 1 day.'}, {'measure': 'Percentage of Participants With Adverse Events (AEs)', 'timeFrame': 'Up to 28 months', 'description': 'An AE was any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including abnormal laboratory values or abnormal clinical test results), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Metastatic Breast Cancer']}, 'descriptionModule': {'briefSummary': 'This study will evaluate the efficacy, safety and patient-reported outcomes of trastuzumab emtansine plus atezolizumab compared with trastuzumab emtansine plus placebo in participants with HER2-positive and PD-L1-positive LABC or MBC.Participants must have progressed either during or after prior trastuzumab- (+/- pertuzumab) and taxane-based therapy for LABC/MBC; or during (or within 6 months after completing) trastuzumab- (+/-pertuzumab) and taxane-based therapy in the neoadjuvant and/or adjuvant setting.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* HER2+ and PD-L1+ locally advanced (LABC) or metastatic breast cancer (MBC)\n* Progression must have occurred during most recent treatment for LABC/MBC or during, or within 6 months after completing, neoadjuvant and/or adjuvant therapy\n* Prior treatment with trastuzumab (+/- pertuzumab) and taxane in the neoadjuvant and/or adjuvant, locally advanced, or metastatic setting\n* No more than two prior lines of therapy in the metastatic setting\n* Measurable disease per RESIST version 1.1\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1\n* Life expectancy \\>= 6 months\n* Adequate hematologic and end-organ function\n* For women of childbearing potential: agreement to remain abstinent or use contraception, and agreement to refrain from donating eggs\n* For men: agreement to remain abstinent or use contraceptive measures, and agreement to refrain from donating sperm\n\nExclusion Criteria:\n\n* Prior treatment with trastuzumab emtansine in metastatic setting\n* History of exposure to cumulative doses of anthracyclines\n* Symptomatic or actively progressing central nervous system (CNS) metastases; asymptomatic CNS lesions ≤ 2cm without clinical requirement for local intervention or asymptomatic patients with treated CNS lesions are eligible\n* Current Grade \\>= 3 peripheral neuropathy\n* Cardiopulmonary dysfunction\n* History of malignancy within 5 years prior to initiation of study treatment, with the exception of the cancer under investigation and malignancies with a negligible risk of metastasis or death\n* History of leptomeningeal disease\n* Active or history of autoimmune disease or immune deficiency\n* Active hepatitis B, hepatitis C and/or tuberculosis\n* Prior allogeneic stem cell or solid organ transplantation\n* Receipt of a live, attenuated vaccine within 4 weeks prior to initiation of study treatment, during treatment, or within 5 months following the last dose of study treatment\n* Pregnancy or lactation'}, 'identificationModule': {'nctId': 'NCT04740918', 'acronym': 'KATE3', 'briefTitle': 'A Study of Trastuzumab Emtansine in Combination With Atezolizumab or Placebo as a Treatment for Participants With Human Epidermal Growth Factor 2 (HER2)-Positive and Programmed Death-ligand 1 (PD-L1)-Positive Locally Advanced (LABC) or Metastatic Breast Cancer (MBC)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': 'A Randomized, Multicenter, Double-Blind, Placebo-Controlled Phase III Study of the Efficacy and Safety of Trastuzumab Emtansine in Combination With Atezolizumab or Placebo in Patients With HER2-Positive and PD-L1-Positive Locally Advanced or Metastatic Breast Cancer Who Have Received Prior Trastuzumab- (+/- Pertuzumab) and Taxane-Based Therapy (KATE3)', 'orgStudyIdInfo': {'id': 'MO42319'}, 'secondaryIdInfos': [{'id': '2020-002818-41', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Arm A: Trastuzumab Emtansine and Placebo', 'description': 'Placebo matched to atezolizumab followed by trastuzumab emtansine 3.6 milligrams per kilogram (mg/kg) intravenous (IV) infusion on Day 1 Cycle 1 and thereafter on Day 1 of each 21-day cycle until disease progression, unmanageable toxicity, or study termination by the sponsor.', 'interventionNames': ['Drug: Trastuzumab Emtansine', 'Other: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Arm B: Trastuzumab Emtansine and Atezolizumab', 'description': 'Atezolizumab 1200 mg IV infusion followed by trastuzumab emtansine 3.6 mg/kg IV infusion on Day 1 Cycle 1 and thereafter on Day 1 of each 21-day cycle until disease progression, unmanageable toxicity, or study termination by the Sponsor.', 'interventionNames': ['Drug: Trastuzumab Emtansine', 'Drug: Atezolizumab']}], 'interventions': [{'name': 'Trastuzumab Emtansine', 'type': 'DRUG', 'otherNames': ['Kadcyla, T-DM1, RO5304020'], 'description': 'Trastuzumab emtansine 3.6 mg/kg IV infusion', 'armGroupLabels': ['Arm A: Trastuzumab Emtansine and Placebo', 'Arm B: Trastuzumab Emtansine and Atezolizumab']}, {'name': 'Atezolizumab', 'type': 'DRUG', 'otherNames': ['Tecentriq, RO5541267, MPDL3280A'], 'description': 'Atezolizumab 1200 mg IV infusion', 'armGroupLabels': ['Arm B: Trastuzumab Emtansine and Atezolizumab']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Placebo matched to atezolizumab', 'armGroupLabels': ['Arm A: Trastuzumab Emtansine and Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92373', 'city': 'Redlands', 'state': 'California', 'country': 'United States', 'facility': 'Emad Ibrahim, Md, Inc', 'geoPoint': {'lat': 34.05557, 'lon': -117.18254}}, {'zip': '3000', 'city': 'Melbourne', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Peter MacCallum Cancer Center', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}, {'zip': '41253-190', 'city': 'Salvador', 'state': 'Estado de Bahia', 'country': 'Brazil', 'facility': 'Hospital Sao Rafael - HSR', 'geoPoint': {'lat': -12.97563, 'lon': -38.49096}}, {'zip': '50040-000', 'city': 'Recife', 'state': 'Pernambuco', 'country': 'Brazil', 'facility': 'Hospital do Cancer de Pernambuco - HCP', 'geoPoint': {'lat': -8.05389, 'lon': -34.88111}}, {'zip': '98700-000', 'city': 'Ijuí', 'state': 'Rio Grande do Sul', 'country': 'Brazil', 'facility': 'Oncosite - Centro de Pesquisa Clinica Em Oncologia Ltda', 'geoPoint': {'lat': -28.38778, 'lon': -53.91472}}, {'zip': '15090-000', 'city': 'São José do Rio Preto', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Hospital de Base de Sao Jose do Rio Preto', 'geoPoint': {'lat': -20.81972, 'lon': -49.37944}}, {'zip': '03102-002', 'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Núcleo de Pesquisa São Camilo', 'geoPoint': {'lat': -23.5475, 'lon': 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