Ignite Creation Date:
2025-12-24 @ 7:49 PM
Ignite Modification Date:
2025-12-29 @ 5:08 PM
Study NCT ID:
NCT00524303
Status:
COMPLETED
Last Update Posted:
2016-11-11
First Post:
2007-08-31
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Lapatinib +/- Trastuzumab In Addition To Standard Neoadjuvant Breast Cancer Therapy.
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': 'D000068878', 'term': 'Trastuzumab'}, {'id': 'D017239', 'term': 'Paclitaxel'}, {'id': 'D000077341', 'term': 'Lapatinib'}], 'ancestors': [{'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'}, {'id': 'D043823', 'term': 'Taxoids'}, {'id': 'D043822', 'term': 'Cyclodecanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D011799', 'term': 'Quinazolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '866-435-7343', 'title': 'GSK Response Center', 'organization': 'GlaxoSmithKline'}, 'certainAgreement': {'otherDetails': 'GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'description': 'In the Safety Population, serious and non-serious adverse events were collected from all randomized participants who received at least one dose of investigational product and was based on the actual treatment received if this differed from that to which the participant was randomized.', 'eventGroups': [{'id': 'EG000', 'title': 'Trastuzumab', 'description': 'Participants received trastuzumab alone (a loading dose of 4 milligrams \\[mg\\]/kilogram \\[kg\\] on Day 1, followed by a dose of 2 mg/kg on Day 1 of Week 2 and weekly thereafter). Participants were treated with trastuzumab in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-fluorouracil \\[5-FU\\] 500 mg/meters squared \\[m\\^2\\], epirubicin 75 mg/m\\^2, cyclophosphamide 500 mg/m\\^2 x 4 cycles on Day 1), then paclitaxel (80 mg/m\\^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with trastuzumab.', 'otherNumAtRisk': 32, 'otherNumAffected': 31, 'seriousNumAtRisk': 32, 'seriousNumAffected': 7}, {'id': 'EG001', 'title': 'Lapatinib', 'description': 'Participants received lapatinib alone (1250 mg orally \\[PO\\] once daily \\[QD\\]). Participants were treated with lapatinib in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-FU 500 mg/m\\^2, epirubicin 75 mg/m\\^2, cyclophosphamide 500 mg/m\\^2 x 4 cycles on Day 1), then paclitaxel (80 mg/m\\^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with lapatinib.', 'otherNumAtRisk': 34, 'otherNumAffected': 34, 'seriousNumAtRisk': 34, 'seriousNumAffected': 7}, {'id': 'EG002', 'title': 'Trastuzumab+Lapatinib', 'description': 'Participants received trastuzumab (given as in Arm 1) and lapatinib (750/1000 mg PO QD). Participants were treated with these medications in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-FU 500 mg/m\\^2, epirubicin 75 mg/m\\^2, cyclophosphamide 500 mg/m\\^2 x 4 cycles on Day 1), then paclitaxel (80 mg/m\\^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with trastuzumab+lapatinib.', 'otherNumAtRisk': 31, 'otherNumAffected': 31, 'seriousNumAtRisk': 31, 'seriousNumAffected': 8}], 'otherEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 26}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 26}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 29}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 31}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 24}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 24}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 28}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 26}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 24}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 18}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Neuropathy peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 19}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 14}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 15}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 12}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 10}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 9}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 11}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 9}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 6}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Nail disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 8}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 7}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Mucosal inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 8}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 7}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 7}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 9}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 7}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 5}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 6}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 5}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 6}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 5}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Haemoglobin decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Dry skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Breast pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 4}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Dysuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Hot flush', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Rhinorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 5}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Catheter site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 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Version 14.0'}, {'term': 'Hypocalcaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Procedural pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Proctalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Respiratory tract congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Rhinitis allergic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Skin exfoliation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Visual impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}], 'seriousEvents': [{'term': 'Febrile nuetropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Cellilitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Diverticulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Chest discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Dysponea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Liver function test abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Swelling face', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With Overall Pathological Complete Response (pCR) After 26 Weeks of Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Trastuzumab', 'description': 'Participants received trastuzumab alone (a loading dose of 4 milligrams \\[mg\\]/kilogram \\[kg\\] on Day 1, followed by a dose of 2 mg/kg on Day 1 of Week 2 and weekly thereafter). Participants were treated with trastuzumab in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-fluorouracil \\[5-FU\\] 500 mg/meters squared \\[m\\^2\\], epirubicin 75 mg/m\\^2, cyclophosphamide 500 mg/m\\^2 x 4 cycles on Day 1), then paclitaxel (80 mg/m\\^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with trastuzumab.'}, {'id': 'OG001', 'title': 'Lapatinib', 'description': 'Participants received lapatinib alone (1250 mg orally \\[PO\\] once daily \\[QD\\]). Participants were treated with lapatinib in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-FU 500 mg/m\\^2, epirubicin 75 mg/m\\^2, cyclophosphamide 500 mg/m\\^2 x 4 cycles on Day 1), then paclitaxel (80 mg/m\\^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with lapatinib.'}, {'id': 'OG002', 'title': 'Trastuzumab+Lapatinib', 'description': 'Participants received trastuzumab (given as in Arm 1) and lapatinib (750/1000 mg PO QD). Participants were treated with these medications in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-FU 500 mg/m\\^2, epirubicin 75 mg/m\\^2, cyclophosphamide 500 mg/m\\^2 x 4 cycles on Day 1), then paclitaxel (80 mg/m\\^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with trastuzumab+lapatinib.'}], 'classes': [{'categories': [{'measurements': [{'value': '54.0', 'groupId': 'OG000'}, {'value': '45.0', 'groupId': 'OG001'}, {'value': '74.0', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Percent difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-9', 'ciLowerLimit': '-38.1', 'ciUpperLimit': '17.9', 'estimateComment': 'Approximate 95% confidence interval for the difference in response rates between the trastuzumab arm and the lapatinib arm was calculated.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Percent difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '20', 'ciLowerLimit': '-8.0', 'ciUpperLimit': '49.4', 'estimateComment': 'Approximate 95% confidence interval for the difference in response rates between the transtuzumab arm and the transtuzumab + lapatinib arm was calculated.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Week 26', 'description': 'A pCR in the breast was defined as no pathologic evidence of invasive disease (residual ductal carcinoma in situ \\[DCIS\\] or lobular carcinoma in situ \\[LCIS\\] was allowed). A pCR in the axillary lymph node(s) was defined as no evidence of breast cancer cells in the lymph node (including subcapsular sinus). Overall pCR was defined as the sum of pCR in the breast and pCR in the lymph nodes. 26 weeks of therapy comprised the 2-week run-in phase, 12 weeks of treatment with FEC, and 12 weeks of treatment with Paclitaxel.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat-Evaluable (ITT-E) Population: ITT participants with evaluable tumor responses who had been \\>=75% compliant to 5-fluorouracil (5-FU) 500 mg/m\\^2, epirubicin 75 mg/m\\^2, cyclophosphamide 500 mg/m\\^2 (FEC75) and paclitaxel 80 mg/m\\^2 and had undergone surgery.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Clinical Complete Response (cCR) at 26 Weeks or at End of Treatment (EOT) or Early Withdrawal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Trastuzumab', 'description': 'Participants received trastuzumab alone (a loading dose of 4 milligrams \\[mg\\]/kilogram \\[kg\\] on Day 1, followed by a dose of 2 mg/kg on Day 1 of Week 2 and weekly thereafter). Participants were treated with trastuzumab in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-fluorouracil \\[5-FU\\] 500 mg/meters squared \\[m\\^2\\], epirubicin 75 mg/m\\^2, cyclophosphamide 500 mg/m\\^2 x 4 cycles on Day 1), then paclitaxel (80 mg/m\\^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with trastuzumab.'}, {'id': 'OG001', 'title': 'Lapatinib', 'description': 'Participants received lapatinib alone (1250 mg orally \\[PO\\] once daily \\[QD\\]). Participants were treated with lapatinib in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-FU 500 mg/m\\^2, epirubicin 75 mg/m\\^2, cyclophosphamide 500 mg/m\\^2 x 4 cycles on Day 1), then paclitaxel (80 mg/m\\^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with lapatinib.'}, {'id': 'OG002', 'title': 'Trastuzumab+Lapatinib', 'description': 'Participants received trastuzumab (given as in Arm 1) and lapatinib (750/1000 mg PO QD). Participants were treated with these medications in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-FU 500 mg/m\\^2, epirubicin 75 mg/m\\^2, cyclophosphamide 500 mg/m\\^2 x 4 cycles on Day 1), then paclitaxel (80 mg/m\\^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with trastuzumab+lapatinib.'}], 'classes': [{'categories': [{'measurements': [{'value': '61.0', 'groupId': 'OG000'}, {'value': '68.0', 'groupId': 'OG001'}, {'value': '61.0', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.627', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Percent Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '7', 'ciLowerLimit': '-17.8', 'ciUpperLimit': '32.5', 'estimateComment': 'Approximate 95% confidence interval for the difference in response rates between the transtuzumab arm and the lapatinib arm was calculated.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '1.000', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Percent Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0', 'ciLowerLimit': '-25.1', 'ciUpperLimit': '25.1', 'estimateComment': 'Approximate 95% confidence interval for the difference in response rates between the transtuzumab arm and the transtuzumab + lapatinib arm was calculated.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Week 26 or EOT or Early withdrawal', 'description': 'cCR was defined as the percentage of participants achieving either a Complete Response (CR) or a Partial Response (PR) using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. CR was defined as the disappearance of all target lesions, and PR was defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population: all randomized participants regardless of whether they had received any treatment.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants (Par.) With Disease-free Survival (DFS) at the End of 5 Years From Randomization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Trastuzumab', 'description': 'Participants received trastuzumab alone (a loading dose of 4 milligrams \\[mg\\]/kilogram \\[kg\\] on Day 1, followed by a dose of 2 mg/kg on Day 1 of Week 2 and weekly thereafter). Participants were treated with trastuzumab in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-fluorouracil \\[5-FU\\] 500 mg/meters squared \\[m\\^2\\], epirubicin 75 mg/m\\^2, cyclophosphamide 500 mg/m\\^2 x 4 cycles on Day 1), then paclitaxel (80 mg/m\\^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with trastuzumab.'}, {'id': 'OG001', 'title': 'Lapatinib', 'description': 'Participants received lapatinib alone (1250 mg orally \\[PO\\] once daily \\[QD\\]). Participants were treated with lapatinib in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-FU 500 mg/m\\^2, epirubicin 75 mg/m\\^2, cyclophosphamide 500 mg/m\\^2 x 4 cycles on Day 1), then paclitaxel (80 mg/m\\^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with lapatinib.'}, {'id': 'OG002', 'title': 'Trastuzumab+Lapatinib', 'description': 'Participants received trastuzumab (given as in Arm 1) and lapatinib (750/1000 mg PO QD). Participants were treated with these medications in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-FU 500 mg/m\\^2, epirubicin 75 mg/m\\^2, cyclophosphamide 500 mg/m\\^2 x 4 cycles on Day 1), then paclitaxel (80 mg/m\\^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with trastuzumab+lapatinib.'}], 'classes': [{'categories': [{'measurements': [{'value': '90', 'groupId': 'OG000', 'lowerLimit': '72', 'upperLimit': '97'}, {'value': '67', 'groupId': 'OG001', 'lowerLimit': '47', 'upperLimit': '80'}, {'value': '66', 'groupId': 'OG002', 'lowerLimit': '44', 'upperLimit': '82'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From first dose date until disease progression, assessed up to a maximum of 5 years', 'description': 'Percentage is the Kaplan Meier estimate of DFS. DFS is time from randomization until disease recurrence (contralateral breast cancer; second primary cancer; progression during neo-adjuvant treatment; or death from any cause). Par. who experienced progression during treatment and were withdrawn were considered to have a DFS event at withdrawal.', 'unitOfMeasure': 'Percentage', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population'}, {'type': 'SECONDARY', 'title': 'Number of Participants With the Indicated Electrocardiogram (ECG) Status at Baseline and at EOT or Early Withdrawal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Trastuzumab', 'description': 'Participants received trastuzumab alone (a loading dose of 4 milligrams \\[mg\\]/kilogram \\[kg\\] on Day 1, followed by a dose of 2 mg/kg on Day 1 of Week 2 and weekly thereafter). Participants were treated with trastuzumab in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-fluorouracil \\[5-FU\\] 500 mg/meters squared \\[m\\^2\\], epirubicin 75 mg/m\\^2, cyclophosphamide 500 mg/m\\^2 x 4 cycles on Day 1), then paclitaxel (80 mg/m\\^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with trastuzumab.'}, {'id': 'OG001', 'title': 'Lapatinib', 'description': 'Participants received lapatinib alone (1250 mg orally \\[PO\\] once daily \\[QD\\]). Participants were treated with lapatinib in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-FU 500 mg/m\\^2, epirubicin 75 mg/m\\^2, cyclophosphamide 500 mg/m\\^2 x 4 cycles on Day 1), then paclitaxel (80 mg/m\\^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with lapatinib.'}, {'id': 'OG002', 'title': 'Trastuzumab+Lapatinib', 'description': 'Participants received trastuzumab (given as in Arm 1) and lapatinib (750/1000 mg PO QD). Participants were treated with these medications in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-FU 500 mg/m\\^2, epirubicin 75 mg/m\\^2, cyclophosphamide 500 mg/m\\^2 x 4 cycles on Day 1), then paclitaxel (80 mg/m\\^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with trastuzumab+lapatinib.'}], 'classes': [{'title': 'Baseline, Normal, n= 28, 32, 30', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}]}]}, {'title': 'Baseline, Abnormal-NCS, n= 28, 32, 30', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}]}, {'title': 'Baseline, Abnormal-CS, n= 28, 32, 30', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'EOT/early withdrawal, Normal, n= 16, 21, 16', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}]}, {'title': 'EOT/early withdrawal, Abnormal-NCS, n= 16, 21, 16', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}, {'title': 'EOT/early withdrawal, Abnormal-CS, n= 16, 21, 16', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and EOT (up to Week 26) or Early withdrawal', 'description': '12-lead ECGs were performed, and participants were classified as having normal ECG, abnormal- not clinically significant (NCS) ECG, and abnormal-clinically significant (CS) ECG per investigator opinion and reported result.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': "Safety Population: all randomized participants (par) who received at least one dose of investigational product, based on actual treatment received if this differed from that to which par was randomized. Not all par were analyzed: some par were randomized to an arm they did not want or par were randomized in error (eligibility criteria weren't met)."}, {'type': 'SECONDARY', 'title': 'Cumulative Number of Participants With at Least One Decrease of More Than or Equal to 20% in Left Ventricular Ejection Fraction (LVEF) at the Indicated Time Points Compared to LVEF at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Trastuzumab', 'description': 'Participants received trastuzumab alone (a loading dose of 4 milligrams (mg)/kilogram (kg) on Day 1, followed by a dose of 2 mg/kg on Day 1 of Week 2 and weekly thereafter. Participants were treated with trastuzumab in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-fluorouracil \\[5-FU\\] 500 mg/meters squared \\[m\\^2\\], epirubicin 75 mg/m\\^2, cyclophosphamide 500 mg/m\\^2 x 4 cycles on Day 1), then paclitaxel 80 mg/m\\^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with trastuzumab.'}, {'id': 'OG001', 'title': 'Lapatinib', 'description': 'Participants received lapatinib alone (1250 mg orally \\[PO\\] once daily \\[QD\\]). Participants were treated with lapatinib in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-FU 500 mg/m\\^2, epirubicin 75 mg/m\\^2, cyclophosphamide 500 mg/m\\^2 x 4 cycles on Day 1), then paclitaxel 80 mg/m\\^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with lapatinib.'}, {'id': 'OG002', 'title': 'Trastuzumab+Lapatinib', 'description': 'Participants received trastuzumab (given as in Arm 1) and lapatinib (750/1000 mg PO QD). Participants were treated with these medications in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-FU 500 mg/m\\^2, epirubicin 75 mg/m\\^2, cyclophosphamide 500 mg/m\\^2 x 4 cycles on Day 1), then paclitaxel 80 mg/m\\^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with trastuzumab+lapatinib.'}], 'classes': [{'title': 'Week 3, n= 30, 31, 26', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Week 9, n= 30, 32, 27', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Week 15, n= 31, 34, 28', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Early withdrawal/EOT, n= 31, 34, 28', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': '3-month survival follow-up, n= 31, 34, 28', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': '6-month survival follow-up, n= 31, 34, 28', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 3, 9, and 15; EOT or early withdrawal; and 3- and 6-month survival follow-up after last chemotherapy course', 'description': 'LVEF is the measurement of how much blood is being pumped out of the left ventricle of the heart (the main pumping chamber) with each contraction and is used to determine cardiac function. LVEF was measured by performing echocardiogram (ECHO). If ECHO could not be performed or if the investigator believed that it was not conclusive to evaluate LVEF, then a multigated acquisition (MUGA) scan was performed.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': "Safety Population. Not all participants in the Safety Population were analyzed: some participants were randomized to an arm they did not want or participants were randomized in error (eligibility criteria weren't met)."}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Mean Intra-tumoral Expression of the Indicated Proteins at Baseline and Day 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Trastuzumab', 'description': 'Participants received trastuzumab alone (a loading dose of 4 milligrams \\[mg\\]/kilogram \\[kg\\] on Day 1, followed by a dose of 2 mg/kg on Day 1 of Week 2 and weekly thereafter). Participants were treated with trastuzumab in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-fluorouracil \\[5-FU\\] 500 mg/meters squared \\[m\\^2\\], epirubicin 75 mg/m\\^2, cyclophosphamide 500 mg/m\\^2 x 4 cycles on Day 1), then paclitaxel (80 mg/m\\^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with trastuzumab.'}, {'id': 'OG001', 'title': 'Lapatinib', 'description': 'Participants received lapatinib alone (1250 mg orally \\[PO\\] once daily \\[QD\\]). Participants were treated with lapatinib in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-FU 500 mg/m\\^2, epirubicin 75 mg/m\\^2, cyclophosphamide 500 mg/m\\^2 x 4 cycles on Day 1), then paclitaxel (80 mg/m\\^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with lapatinib.'}], 'classes': [{'title': 'Baseline, EGFR_Tyr1068; pCR=yes, n=0, 4', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'This protein was not significantly expressed at this time point in this treatment arm.', 'groupId': 'OG000'}, {'value': '-0.70', 'spread': '0.47', 'groupId': 'OG001'}]}]}, {'title': 'Baseline, Baseline, EGFR_Tyr1068; pCR=no, n=0, 11', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'This protein was not significantly expressed at this time point in this treatment arm.', 'groupId': 'OG000'}, {'value': '0.05', 'spread': '0.55', 'groupId': 'OG001'}]}]}, {'title': 'Post Baseline, EGFR_Tyr1068; pCR=yes, n=9, 0', 'categories': [{'measurements': [{'value': '0.65', 'spread': '1.02', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'This protein was not significantly expressed at this time point in this treatment arm.', 'groupId': 'OG001'}]}]}, {'title': 'Post Baseline, EGFR_Tyr1068; pCR=no, n=6, 0', 'categories': [{'measurements': [{'value': '-0.26', 'spread': '0.56', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'This protein was not significantly expressed at this time point in this treatment arm.', 'groupId': 'OG001'}]}]}, {'title': 'Day 14, pSTAT5; pCR=yes, n=11, 6', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'This protein was not significantly expressed at this time point in this treatment arm.', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'This protein was not significantly expressed at this time point in this treatment arm.', 'groupId': 'OG001'}]}]}, {'title': 'Day 14, pSTAT5; pCR=no, n=9, 11', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'This protein was not significantly expressed at this time point in this treatment arm.', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'This protein was not significantly expressed at this time point in this treatment arm.', 'groupId': 'OG001'}]}]}, {'title': 'Post Baseline, PI3K; pCR=yes, n=0, 5', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'This protein was not significantly expressed at this time point in this treatment arm.', 'groupId': 'OG000'}, {'value': '0.46', 'spread': '0.73', 'groupId': 'OG001'}]}]}, {'title': 'Post Baseline, PI3K; pCR=no, n=0, 10', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'This protein was not significantly expressed at this time point in this treatment arm.', 'groupId': 'OG000'}, {'value': '-0.53', 'spread': '0.67', 'groupId': 'OG001'}]}]}, {'title': 'Post Baseline, LC3B; pCR=yes, n=0, 5', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'This protein was not significantly expressed at this time point in this treatment arm.', 'groupId': 'OG000'}, {'value': '0.68', 'spread': '0.81', 'groupId': 'OG001'}]}]}, {'title': 'Post Baseline, LC3B; pCR=no, n=0, 10', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'This protein was not significantly expressed at this time point in this treatment arm.', 'groupId': 'OG000'}, {'value': '-0.43', 'spread': '0.75', 'groupId': 'OG001'}]}]}, {'title': 'Post Baseline, MMP9; pCR=yes, n=0, 5', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'This protein was not significantly expressed at this time point in this treatment arm.', 'groupId': 'OG000'}, {'value': '0.71', 'spread': '0.34', 'groupId': 'OG001'}]}]}, {'title': 'Post Baseline, MMP9; pCR=no, n=0, 5', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'This protein was not significantly expressed at this time point in this treatment arm.', 'groupId': 'OG000'}, {'value': '-0.48', 'spread': '0.48', 'groupId': 'OG001'}]}]}, {'title': 'Post Baseline, GSK3_a_b_Tyr279_216; pCR=yes, n=8,0', 'categories': [{'measurements': [{'value': '0.26', 'spread': '0.82', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'This protein was not significantly expressed at this time point in this treatment arm.', 'groupId': 'OG001'}]}]}, {'title': 'Post Baseline, GSK3_a_b_Tyr279_216; pCR=no, n=5,0', 'categories': [{'measurements': [{'value': '-0.86', 'spread': '0.67', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'This protein was not significantly expressed at this time point in this treatment arm.', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Tumor core biopsy taken at Baseline and Treatment Day 14', 'description': 'Expression (exp) of biomarker proteins (prot) were analyzed to determine if individual prot levels either in the Baseline or Day 14 breast tumor biopsy specimen correlated with breast pCR. A biomarker indicates a change in exp or state of a prot that correlates with the risk or disease progression, or with the susceptibility of the disease to a given treatment. Biomarkers are characteristic biological properties that can be detected and measured in parts of the body like blood or tissue. pCR=yes: participants (par.) had breast pCR. pCR=no: par. did not have breast pCR. Prot exp values are represented as normalized, scaled values; the unit of measurement is unit-less. Raw exp values were processed as follows: background subtraction of the raw exp value, then that value divided by beta-acting exp to normalize the exp value. A Standard Z score was calculated to scale the exp value.', 'unitOfMeasure': ': normalized relative expression level', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT-E Population. Only those participants with matched pairs of biopsy samples for analysis at Baseline and on Day 14 were analyzed.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Cancer Stem Cells and the Correlation to Response/Non-response to Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Trastuzumab', 'description': 'Participants received trastuzumab alone (a loading dose of 4 milligrams \\[mg\\]/kilogram \\[kg\\] on Day 1, followed by a dose of 2 mg/kg on Day 1 of Week 2 and weekly thereafter). Participants were treated with trastuzumab in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-fluorouracil \\[5-FU\\] 500 mg/meters squared \\[m\\^2\\], epirubicin 75 mg/m\\^2, cyclophosphamide 500 mg/m\\^2 x 4 cycles on Day 1), then paclitaxel (80 mg/m\\^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with trastuzumab.'}, {'id': 'OG001', 'title': 'Lapatinib', 'description': 'Participants received lapatinib alone (1250 mg orally \\[PO\\] once daily \\[QD\\]). Participants were treated with lapatinib in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-FU 500 mg/m\\^2, epirubicin 75 mg/m\\^2, cyclophosphamide 500 mg/m\\^2 x 4 cycles on Day 1), then paclitaxel (80 mg/m\\^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with lapatinib.'}, {'id': 'OG002', 'title': 'Trastuzumab+Lapatinib', 'description': 'Participants received trastuzumab (given as in Arm 1) and lapatinib (750/1000 mg PO QD). Participants were treated with these medications in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-FU 500 mg/m\\^2, epirubicin 75 mg/m\\^2, cyclophosphamide 500 mg/m\\^2 x 4 cycles on Day 1), then paclitaxel (80 mg/m\\^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with trastuzumab+lapatinib.'}], 'timeFrame': 'Tumor core biopsy taken at Baseline and Treatment Day 14', 'description': 'Stem cell data were of poor quality and thus could not be analyzed. Increases or decreases in cancer stem cells and how the changes correlated with response/non-response to treatment were to have been assessed.', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Transcriptional Profiling of Total RNA and the Correlation to Response/Non-response to Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Trastuzumab', 'description': 'Participants received trastuzumab alone (a loading dose of 4 milligrams \\[mg\\]/kilogram \\[kg\\] on Day 1, followed by a dose of 2 mg/kg on Day 1 of Week 2 and weekly thereafter). Participants were treated with trastuzumab in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-fluorouracil \\[5-FU\\] 500 mg/meters squared \\[m\\^2\\], epirubicin 75 mg/m\\^2, cyclophosphamide 500 mg/m\\^2 x 4 cycles on Day 1), then paclitaxel (80 mg/m\\^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with trastuzumab.'}, {'id': 'OG001', 'title': 'Lapatinib', 'description': 'Participants received lapatinib alone (1250 mg orally \\[PO\\] once daily \\[QD\\]). Participants were treated with lapatinib in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-FU 500 mg/m\\^2, epirubicin 75 mg/m\\^2, cyclophosphamide 500 mg/m\\^2 x 4 cycles on Day 1), then paclitaxel (80 mg/m\\^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with lapatinib.'}, {'id': 'OG002', 'title': 'Trastuzumab+Lapatinib', 'description': 'Participants received trastuzumab (given as in Arm 1) and lapatinib (750/1000 mg PO QD). Participants were treated with these medications in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-FU 500 mg/m\\^2, epirubicin 75 mg/m\\^2, cyclophosphamide 500 mg/m\\^2 x 4 cycles on Day 1), then paclitaxel (80 mg/m\\^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with trastuzumab+lapatinib.'}], 'timeFrame': 'Tumor core biopsy taken at Baseline and Treatment Day 14', 'description': 'Transcriptional data were of poor quality and thus could not be analyzed. Gene pathways that correlate with response/non-response to treatment were to have been evaluated. The unit of measure is unit less; however, the processed values would be considered normalized relative expression level.', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Trastuzumab', 'description': 'Participants received trastuzumab alone (a loading dose of 4 milligrams \\[mg\\]/kilogram \\[kg\\] on Day 1, followed by a dose of 2 mg/kg on Day 1 of Week 2 and weekly thereafter). Participants were treated with trastuzumab in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-fluorouracil \\[5-FU\\] 500 mg/meters squared \\[m\\^2\\], epirubicin 75 mg/m\\^2, cyclophosphamide 500 mg/m\\^2 x 4 cycles on Day 1), then paclitaxel (80 mg/m\\^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with trastuzumab.'}, {'id': 'FG001', 'title': 'Lapatinib', 'description': 'Participants received lapatinib alone (1250 mg orally \\[PO\\] once daily \\[QD\\]). Participants were treated with lapatinib in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-FU 500 mg/m\\^2, epirubicin 75 mg/m\\^2, cyclophosphamide 500 mg/m\\^2 x 4 cycles on Day 1), then paclitaxel (80 mg/m\\^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with lapatinib.'}, {'id': 'FG002', 'title': 'Trastuzumab+Lapatinib', 'description': 'Participants received trastuzumab (given as in Arm 1) and lapatinib (750/1000 mg PO QD). Participants were treated with these medications in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-FU 500 mg/m\\^2, epirubicin 75 mg/m\\^2, cyclophosphamide 500 mg/m\\^2 x 4 cycles on Day 1), then paclitaxel (80 mg/m\\^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with trastuzumab+lapatinib.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '33'}, {'groupId': 'FG001', 'numSubjects': '34'}, {'groupId': 'FG002', 'numSubjects': '33'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '24'}, {'groupId': 'FG002', 'numSubjects': '15'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '18'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '4'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'Did not Complete Study Dosing', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Worsening Peripheral Neuropathy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Disease Progression', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Disease Recurrence', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Sponsor Request', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Completed 5 years', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}, {'value': '100', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Trastuzumab', 'description': 'Participants received trastuzumab alone (a loading dose of 4 milligrams \\[mg\\]/kilogram \\[kg\\] on Day 1, followed by a dose of 2 mg/kg on Day 1 of Week 2 and weekly thereafter). Participants were treated with trastuzumab in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-fluorouracil \\[5-FU\\] 500 mg/meters squared \\[m\\^2\\], epirubicin 75 mg/m\\^2, cyclophosphamide 500 mg/m\\^2 x 4 cycles on Day 1), then paclitaxel (80 mg/m\\^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with trastuzumab.'}, {'id': 'BG001', 'title': 'Lapatinib', 'description': 'Participants received lapatinib alone (1250 mg orally \\[PO\\] once daily \\[QD\\]). Participants were treated with lapatinib in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-FU 500 mg/m\\^2, epirubicin 75 mg/m\\^2, cyclophosphamide 500 mg/m\\^2 x 4 cycles on Day 1), then paclitaxel (80 mg/m\\^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with lapatinib.'}, {'id': 'BG002', 'title': 'Trastuzumab+Lapatinib', 'description': 'Participants received trastuzumab (given as in Arm 1) and lapatinib (750/1000 mg PO QD). Participants were treated with these medications in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-FU 500 mg/m\\^2, epirubicin 75 mg/m\\^2, cyclophosphamide 500 mg/m\\^2 x 4 cycles on Day 1), then paclitaxel (80 mg/m\\^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with trastuzumab+lapatinib.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '51.1', 'spread': '10.90', 'groupId': 'BG000'}, {'value': '50.8', 'spread': '8.76', 'groupId': 'BG001'}, {'value': '49.2', 'spread': '10.47', 'groupId': 'BG002'}, {'value': '50.4', 'spread': '10.01', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}, {'value': '100', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'African American/African heritage', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}]}]}, {'title': 'American Indian or Alaska native', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}, {'title': 'Asian - Central/South Asian heritage', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}, {'title': 'Asian - East Asian heritage', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}, {'title': 'Asian - South East Asian heritage', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}]}, {'title': 'White - Arabic/North African heritage', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}, {'title': 'White - White/Caucasian/European heritage', 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}, {'value': '81', 'groupId': 'BG003'}]}]}, {'title': 'Mixed race', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'completionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-09-23', 'studyFirstSubmitDate': '2007-08-31', 'resultsFirstSubmitDate': '2011-07-14', 'studyFirstSubmitQcDate': '2007-08-31', 'lastUpdatePostDateStruct': {'date': '2016-11-11', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-07-14', 'studyFirstPostDateStruct': {'date': '2007-09-03', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-08-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Mean Intra-tumoral Expression of the Indicated Proteins at Baseline and Day 14', 'timeFrame': 'Tumor core biopsy taken at Baseline and Treatment Day 14', 'description': 'Expression (exp) of biomarker proteins (prot) were analyzed to determine if individual prot levels either in the Baseline or Day 14 breast tumor biopsy specimen correlated with breast pCR. A biomarker indicates a change in exp or state of a prot that correlates with the risk or disease progression, or with the susceptibility of the disease to a given treatment. Biomarkers are characteristic biological properties that can be detected and measured in parts of the body like blood or tissue. pCR=yes: participants (par.) had breast pCR. pCR=no: par. did not have breast pCR. Prot exp values are represented as normalized, scaled values; the unit of measurement is unit-less. Raw exp values were processed as follows: background subtraction of the raw exp value, then that value divided by beta-acting exp to normalize the exp value. A Standard Z score was calculated to scale the exp value.'}, {'measure': 'Cancer Stem Cells and the Correlation to Response/Non-response to Treatment', 'timeFrame': 'Tumor core biopsy taken at Baseline and Treatment Day 14', 'description': 'Stem cell data were of poor quality and thus could not be analyzed. Increases or decreases in cancer stem cells and how the changes correlated with response/non-response to treatment were to have been assessed.'}, {'measure': 'Transcriptional Profiling of Total RNA and the Correlation to Response/Non-response to Treatment', 'timeFrame': 'Tumor core biopsy taken at Baseline and Treatment Day 14', 'description': 'Transcriptional data were of poor quality and thus could not be analyzed. Gene pathways that correlate with response/non-response to treatment were to have been evaluated. The unit of measure is unit less; however, the processed values would be considered normalized relative expression level.'}], 'primaryOutcomes': [{'measure': 'Percentage of Participants With Overall Pathological Complete Response (pCR) After 26 Weeks of Therapy', 'timeFrame': 'Week 26', 'description': 'A pCR in the breast was defined as no pathologic evidence of invasive disease (residual ductal carcinoma in situ \\[DCIS\\] or lobular carcinoma in situ \\[LCIS\\] was allowed). A pCR in the axillary lymph node(s) was defined as no evidence of breast cancer cells in the lymph node (including subcapsular sinus). Overall pCR was defined as the sum of pCR in the breast and pCR in the lymph nodes. 26 weeks of therapy comprised the 2-week run-in phase, 12 weeks of treatment with FEC, and 12 weeks of treatment with Paclitaxel.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With Clinical Complete Response (cCR) at 26 Weeks or at End of Treatment (EOT) or Early Withdrawal', 'timeFrame': 'Week 26 or EOT or Early withdrawal', 'description': 'cCR was defined as the percentage of participants achieving either a Complete Response (CR) or a Partial Response (PR) using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. CR was defined as the disappearance of all target lesions, and PR was defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD.'}, {'measure': 'Percentage of Participants (Par.) With Disease-free Survival (DFS) at the End of 5 Years From Randomization', 'timeFrame': 'From first dose date until disease progression, assessed up to a maximum of 5 years', 'description': 'Percentage is the Kaplan Meier estimate of DFS. DFS is time from randomization until disease recurrence (contralateral breast cancer; second primary cancer; progression during neo-adjuvant treatment; or death from any cause). Par. who experienced progression during treatment and were withdrawn were considered to have a DFS event at withdrawal.'}, {'measure': 'Number of Participants With the Indicated Electrocardiogram (ECG) Status at Baseline and at EOT or Early Withdrawal', 'timeFrame': 'Baseline and EOT (up to Week 26) or Early withdrawal', 'description': '12-lead ECGs were performed, and participants were classified as having normal ECG, abnormal- not clinically significant (NCS) ECG, and abnormal-clinically significant (CS) ECG per investigator opinion and reported result.'}, {'measure': 'Cumulative Number of Participants With at Least One Decrease of More Than or Equal to 20% in Left Ventricular Ejection Fraction (LVEF) at the Indicated Time Points Compared to LVEF at Baseline', 'timeFrame': 'Weeks 3, 9, and 15; EOT or early withdrawal; and 3- and 6-month survival follow-up after last chemotherapy course', 'description': 'LVEF is the measurement of how much blood is being pumped out of the left ventricle of the heart (the main pumping chamber) with each contraction and is used to determine cardiac function. LVEF was measured by performing echocardiogram (ECHO). If ECHO could not be performed or if the investigator believed that it was not conclusive to evaluate LVEF, then a multigated acquisition (MUGA) scan was performed.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['ErbB2 Overexpressing', 'ErbB2 Positive', 'Lapatinib', 'Invasive Breast Cancer'], 'conditions': ['Neoplasms, Breast']}, 'referencesModule': {'references': [{'pmid': '29156708', 'type': 'DERIVED', 'citation': "O'Shea J, Cremona M, Morgan C, Milewska M, Holmes F, Espina V, Liotta L, O'Shaughnessy J, Toomey S, Madden SF, Carr A, Elster N, Hennessy BT, Eustace AJ. A preclinical evaluation of the MEK inhibitor refametinib in HER2-positive breast cancer cell lines including those with acquired resistance to trastuzumab or lapatinib. Oncotarget. 2017 Jul 22;8(49):85120-85135. doi: 10.18632/oncotarget.19461. eCollection 2017 Oct 17."}, {'pmid': '24304724', 'type': 'DERIVED', 'citation': "Holmes FA, Espina V, Liotta LA, Nagarwala YM, Danso M, McIntyre KJ, Osborne CR, Anderson T, Krekow L, Blum JL, Pippen J, Florance A, Mahoney J, O'Shaughnessy JA. Pathologic complete response after preoperative anti-HER2 therapy correlates with alterations in PTEN, FOXO, phosphorylated Stat5, and autophagy protein signaling. BMC Res Notes. 2013 Dec 5;6:507. doi: 10.1186/1756-0500-6-507."}]}, 'descriptionModule': {'briefSummary': 'This study will examine safety and efficacy of Lapatinib in combination with a standard neoadjuvant chemotherapy including 5FU, Epirubicin, Cyclophosphamide and Paclitaxel. Tumor tissue will be obtained at 3 timepoints (optional 4th) to evaluate tumor response to treatment.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Have signed an informed consent form (ICF) and a Patient Authorization Form (HIPAA).\n* Have histologically or cytologically confirmed ErbB2- (HER2/neu-) overexpressing invasive breast cancer (T2-4, N0-2).\n* ErbB2 overexpressing breast cancer, defined as one of the following definitions:\n* 3+ staining by immunohistochemistry (IHC),\n* a fluorescent in situ hybridization (FISH) result of more than six HER2 gene copies per nucleus\n* a FISH ratio of more than 2.2.\n* Have either measurable or evaluable disease.\n* Have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1 (Refer to Section 11.4).\n* Have LVEF within the institutional range of normal as measured by either echocardiogram (ECHO) or MUGA scans. The same modality must be used consistently throughout the study.\n* Be deemed able to tolerate 8 cycles of preoperative chemotherapy, including 4 cycles with an anthracycline (epirubicin).\n* Must be willing to undergo 2 mandatory core biopsies (4 passes each) after diagnosis to obtain tissue for biologic expression profiling. Any subject with clinically palpable residual disease may undergo an optional third biopsy to allow identification of presumed pathways of resistance to therapy. This information might be useful in providing the subject with options for other targeted therapies if definitive surgery confirms residual disease. Definitive local therapy with surgery and radiation therapy as indicated will be performed after completion of 12 weeks of paclitaxel-based chemotherapy.\n* Are able to swallow and retain oral medication (intact pill).\n* Are able to complete all screening assessments as outlined in the protocol.\n* Have adequate organ function as defined in Table 4:\n\nTable 1 Baseline Laboratory Values\n\nHematologic:\n\nANC (absolute neutrophil count) \\>1.5 x 109/L hemoglobin \\>9 g/dL platelets \\>75 x 109/L\n\nHepatic:\n\nalbumin \\>2.5 g/dL serum bilirubin \\<1.25 x ULN AST / ALT \\<3 x ULN if no documented liver metastases AST / ALT \\<3 x ULN with documented liver metastases\n\nRenal:\n\nserum creatinine \\<2.0 mg/dL\n\n* OR - calculated creatinine clearance \\>40 mL/min\n* Are subjects aged \\>18 years with any menopausal status:\n\nNon-child-bearing potential (i.e., women with functioning ovaries who have a current documented tubal ligation or hysterectomy, or women who are postmenopausal)\n\nChild-bearing potential (i.e., women with functioning ovaries and no documented impairment of oviductal or uterine function that would cause sterility.) This category includes women with oligomenorrhea (severe), women who are perimenopausal, and young women who have begun to menstruate. These subjects must have a negative serum pregnancy test at screening and agree to one of the following:\n\nComplete abstinence from intercourse from 2 weeks prior to administration of the first dose of study medication until 28 days after the final dose of study medication; or Consistent and correct use of one of the following acceptable methods of birth control: male partner who is sterile prior to the female subject's entry into the study and is the sole sexual partner for that female subject; any intrauterine device (IUD) with a documented failure rate of less than 1% per year; oral contraceptives (either combined or progestogen only) where not contraindicated for this subject population or per local practice.; or barrier methods, including diaphragm or condom with a spermicide.\n\nPlease note that breast cancer subjects on this trial cannot receive injectable levonorgestrel or injectable progestogen due to the potential for an adverse effect of anti-hormonal therapies on chemotherapy administered for breast cancer \\[Albain, 2002\\]. Progestogen may also affect the proliferative rate of endocrine-responsive tumors.\n\nExclusion Criteria:\n\n* Have received any prior chemotherapy.\n* Had prior therapy with an ErbB1 and/or ErbB2 inhibitor.\n* Are receiving concurrent anti-cancer therapy (chemotherapy, immunotherapy, and biologic therapy) while taking study medication.\n* Have malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel. Women with ulcerative colitis are also excluded.\n* Have a concurrent disease or condition that would make the woman inappropriate for study participation, or any serious medical disorder that would interfere with the woman's safety.\n* Have an active or uncontrolled infection.\n* Have dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent.\n* Have active cardiac disease, defined as one or more of the following:\n\nHistory of uncontrolled or symptomatic angina History of arrhythmias requiring medications, or clinically significant Myocardial infarction \\<6 months from study entry Uncontrolled or symptomatic congestive heart failure Ejection fraction below the institutional normal limit Any other cardiac condition, which in the opinion of the treating physician, would make this protocol unreasonably hazardous for the patient\n\n* Are pregnant or breastfeeding.\n* Have received concurrent treatment with an investigational agent or participate in another clinical trial.\n* Have received concurrent treatment with prohibited medications (refer to Section 5.8.2 for details on prohibited medications).\n* Have used an investigational drug within 30 days or 5 half-lives, whichever is longer, preceding the first dose of study medication.\n* Have a known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to any of the agents used in this study or their excipients.\n* Are receiving therapeutic anti-coagulation therapy (i.e. warfarin, heparin)."}, 'identificationModule': {'nctId': 'NCT00524303', 'briefTitle': 'Lapatinib +/- Trastuzumab In Addition To Standard Neoadjuvant Breast Cancer Therapy.', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': 'Phase II Randomized Trial of Neoadjuvant Trastuzumab and/or Lapatinib Plus Chemotherapy (Sequential FEC75 and Paclitaxel) in Women With ErbB2- (HER2/Neu-) Overexpressing Invasive Breast Cancer', 'orgStudyIdInfo': {'id': 'LPT109096'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Arm 1', 'description': 'Trastuzumab alone for 2 weeks then in combination with FEC75 for 4 (21 Day) cycles and Paclitaxel for 4 (21 day) cycles then continued trastuzumab until time of definitive surgery', 'interventionNames': ['Drug: Trastuzumab', 'Drug: Paclitaxel', 'Drug: FEC75']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 2', 'description': 'Lapatinib alone for 2 weeks then in combination with FEC75 for 4 (21 Day) cycles followed by Paclitaxel for 4 (21 day) cycles then continued lapatinib until time of definitive surgery', 'interventionNames': ['Drug: Paclitaxel', 'Drug: FEC75', 'Drug: Lapatinib']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 3', 'description': 'Trastuzumab + Lapatinib for 2 weeks then added FEC75 for 4 (21 Day) cycles followed by Paclitaxel for 4 (21 day) cycles then continued trastuzumab + lapatinib until time of definitive surgery', 'interventionNames': ['Drug: Trastuzumab', 'Drug: Paclitaxel', 'Drug: FEC75', 'Drug: Lapatinib']}], 'interventions': [{'name': 'Trastuzumab', 'type': 'DRUG', 'description': '4mg/kg IV loading dose followed by 2mg/kg IV weekly', 'armGroupLabels': ['Arm 1', 'Arm 3']}, {'name': 'Paclitaxel', 'type': 'DRUG', 'description': '80mg/m2 IV weekly for 4 (21 day) cycles', 'armGroupLabels': ['Arm 1', 'Arm 2', 'Arm 3']}, {'name': 'FEC75', 'type': 'DRUG', 'description': '5FU 500mg/m2 + Epirubicin 75 mg/m2 + cyclophosphamide 500 mg/m2 IV on day 1 of 4 (21 day) cycles', 'armGroupLabels': ['Arm 1', 'Arm 2', 'Arm 3']}, {'name': 'Lapatinib', 'type': 'DRUG', 'description': '1250 mg oral daily dose in arm 2, 750 mg oral daily dose for FEC cycles and then 1000 mg oral daily dose during the Paclitaxel cycles in arm 3', 'armGroupLabels': ['Arm 2', 'Arm 3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92708', 'city': 'Fountain Valley', 'state': 'California', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 33.70918, 'lon': -117.95367}}, {'zip': '90057', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '80220', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '34667', 'city': 'Hudson', 'state': 'Florida', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 28.36445, 'lon': -82.69343}}, {'zip': '33176', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33028', 'city': 'Pembroke Pines', 'state': 'Florida', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 26.00315, 'lon': -80.22394}}, {'zip': '46219', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '89052', 'city': 'Henderson', 'state': 'Nevada', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 36.0397, 'lon': -114.98194}}, {'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '78731', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '77702-1449', 'city': 'Beaumont', 'state': 'Texas', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 30.08605, 'lon': -94.10185}}, {'zip': '76022', 'city': 'Bedford', 'state': 'Texas', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 32.84402, 'lon': -97.14307}}, {'zip': '75231', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '75246', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '75320-2510', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '79915', 'city': 'El Paso', 'state': 'Texas', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 31.75872, 'lon': -106.48693}}, {'zip': '77024', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '75067', 'city': 'Lewisville', 'state': 'Texas', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 33.04623, 'lon': -96.99417}}, {'zip': '77479', 'city': 'Sugar Land', 'state': 'Texas', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 29.61968, 'lon': -95.63495}}, {'zip': '75702', 'city': 'Tyler', 'state': 'Texas', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 32.35126, 'lon': -95.30106}}, {'zip': '23502', 'city': 'Norfolk', 'state': 'Virginia', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 36.84681, 'lon': -76.28522}}, {'zip': '98117', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '98902', 'city': 'Yakima', 'state': 'Washington', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 46.60207, 'lon': -120.5059}}], 'overallOfficials': [{'name': 'GSK Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GlaxoSmithKline'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}