Ignite Creation Date:
2025-12-24 @ 3:54 PM
Ignite Modification Date:
2026-01-04 @ 5:53 PM
Study NCT ID:
NCT00513292
Status:
COMPLETED
Last Update Posted:
2019-01-23
First Post:
2007-08-06
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Combination Chemotherapy and Paclitaxel Plus Trastuzumab in Treating Women With Palpable Breast Cancer That Can Be Removed by Surgery
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': 'D003520', 'term': 'Cyclophosphamide'}, {'id': 'D015251', 'term': 'Epirubicin'}, {'id': 'D017239', 'term': 'Paclitaxel'}, {'id': 'D013660', 'term': 'Taxes'}, {'id': 'D000068878', 'term': 'Trastuzumab'}, {'id': 'C000598430', 'term': 'PF-05280014'}], 'ancestors': [{'id': 'D010752', 'term': 'Phosphoramide Mustards'}, {'id': 'D009588', 'term': 'Nitrogen Mustard Compounds'}, {'id': 'D009150', 'term': 'Mustard Compounds'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D063088', 'term': 'Phosphoramides'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D004317', 'term': 'Doxorubicin'}, {'id': 'D003630', 'term': 'Daunorubicin'}, {'id': 'D018943', 'term': 'Anthracyclines'}, {'id': 'D009279', 'term': 'Naphthacenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D000617', 'term': 'Aminoglycosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D043823', 'term': 'Taxoids'}, {'id': 'D043822', 'term': 'Cyclodecanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D004467', 'term': 'Economics'}, {'id': 'D004472', 'term': 'Health Care Economics and Organizations'}, {'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'abuzdar@mdanderson.org', 'phone': '713-792-2817', 'title': 'Aman U. Buzdar, MD', 'organization': 'University of Texas MD Anderson Cancer Center, Houston, TX, USA'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Arm A', 'description': 'Patients receive FEC comprising fluorouracil IV, epirubicin hydrochloride IV, and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses. Beginning 21 days after completion of FEC, patients receive paclitaxel IV once weekly and trastuzumab (Herceptin) IV once weekly for 12 weeks. Within 6 weeks after completion of paclitaxel and trastuzumab, patients undergo surgery. Beginning 3-4 weeks after surgery, patients receive trastuzumab IV once every 3 weeks for up to 52 weeks. epirubicin hydrochloride: Given IV, cyclophosphamide: Given IV, paclitaxel: Given IV, trastuzumab: Given IV, therapeutic conventional surgery: Undergo surgery, laboratory biomarker analysis: Correlative studies', 'otherNumAtRisk': 138, 'otherNumAffected': 136, 'seriousNumAtRisk': 138, 'seriousNumAffected': 19}, {'id': 'EG001', 'title': 'Arm B', 'description': 'Patients receive paclitaxel IV once weekly and trastuzumab IV once weekly for 12 weeks. Beginning 7 days after the completion of paclitaxel and trastuzumab, patients receive FEC comprising fluorouracil IV, epirubicin IV, and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses. Patients also receive trastuzumab IV once weekly for an additional 12 weeks. Within 6 weeks after completion of FEC and trastuzumab, patients undergo surgery. Beginning 3-4 weeks after surgery, patients receive trastuzumab as in arm I. epirubicin hydrochloride: Given IV, cyclophosphamide: Given IV, paclitaxel: Given IV, trastuzumab: Given IV, therapeutic conventional surgery: Undergo surgery, laboratory biomarker analysis: Correlative studies', 'otherNumAtRisk': 142, 'otherNumAffected': 141, 'seriousNumAtRisk': 142, 'seriousNumAffected': 26}], 'otherEvents': [{'term': 'Blood disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numEvents': 6, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 142, 'numEvents': 7, 'numAffected': 5}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9'}, {'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 142, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9'}, {'term': 'Hemoglobin decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numEvents': 279, 'numAffected': 53}, {'groupId': 'EG001', 'numAtRisk': 142, 'numEvents': 269, 'numAffected': 50}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9'}, {'term': 'Hemolysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 142, 'numEvents': 8, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9'}, {'term': 'Lymph node pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 142, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9'}, {'term': 'Lymphatic disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 142, 'numEvents': 5, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9'}, {'term': 'Thrombotic microangiopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 142, 'numEvents': 8, 'numAffected': 5}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9'}, {'term': 'Arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 142, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9'}, {'term': 'Cardiac disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 142, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9'}, {'term': 'Left ventricular dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 142, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9'}, {'term': 'Left ventricular failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numEvents': 14, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 142, 'numEvents': 25, 'numAffected': 18}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9'}, {'term': 'Myocardial ischemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 142, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numEvents': 7, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 142, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9'}, {'term': 'Pericardial effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 142, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9'}, {'term': 'Premature ventricular contractions', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 142, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9'}, {'term': 'Sinus arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 142, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9'}, {'term': 'Sinus bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 142, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9'}, {'term': 'Sinus tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numEvents': 12, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 142, 'numEvents': 14, 'numAffected': 8}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9'}, {'term': 'Supraventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 142, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9'}, {'term': 'Ventricular arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 142, 'numEvents': 14, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9'}, {'term': 'Ventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 142, 'numEvents': 9, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9'}, {'term': 'Ear disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 142, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9'}, {'term': 'Ear pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 142, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9'}, {'term': 'External ear inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 142, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9'}, {'term': 'External ear pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 142, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9'}, {'term': 'Hearing loss', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 142, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9'}, {'term': 'Middle ear inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 142, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9'}, {'term': 'Tinnitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 142, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9'}, {'term': 'Hypothyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 142, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9'}, {'term': 'Conjunctival disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 142, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9'}, {'term': 'Dry eye syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 142, 'numEvents': 5, 'numAffected': 3}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9'}, {'term': 'Extraocular muscle paresis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 142, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9'}, {'term': 'Eye disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numEvents': 5, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 142, 'numEvents': 17, 'numAffected': 9}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9'}, {'term': 'Eye pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 142, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9'}, {'term': 'Eyelid function disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 142, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9'}, {'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numEvents': 14, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 142, 'numEvents': 37, 'numAffected': 16}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9'}, {'term': 'Watering eyes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 142, 'numEvents': 9, 'numAffected': 3}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 142, 'numEvents': 9, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numEvents': 12, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 142, 'numEvents': 24, 'numAffected': 16}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9'}, {'term': 'Anal hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 142, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9'}, {'term': 'Anal mucositis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 142, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9'}, {'term': 'Colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 142, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numEvents': 142, 'numAffected': 57}, {'groupId': 'EG001', 'numAtRisk': 142, 'numEvents': 113, 'numAffected': 51}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numEvents': 172, 'numAffected': 72}, {'groupId': 'EG001', 'numAtRisk': 142, 'numEvents': 210, 'numAffected': 79}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 142, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numEvents': 48, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 142, 'numEvents': 52, 'numAffected': 24}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9'}, {'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 142, 'numEvents': 9, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9'}, {'term': 'Ear, nose and throat examination abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numEvents': 86, 'numAffected': 46}, {'groupId': 'EG001', 'numAtRisk': 142, 'numEvents': 78, 'numAffected': 41}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9'}, {'term': 'Endoscopy large bowel abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 142, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9'}, {'term': 'Enteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 142, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9'}, {'term': 'Esophageal mucositis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 142, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9'}, {'term': 'Esophagitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 142, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 142, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9'}, {'term': 'Gastric mucositis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 142, 'numEvents': 1, 'numAffected': 1}], 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'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9'}, {'term': 'Hemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numEvents': 6, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 142, 'numEvents': 9, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9'}, {'term': 'Ileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 142, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9'}, {'term': 'Mucositis oral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numEvents': 31, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 142, 'numEvents': 31, 'numAffected': 17}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9'}, {'term': 'Nausea', 'stats': 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'numAtRisk': 138, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 142, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9'}, {'term': 'Chest wall pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 142, 'numEvents': 4, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9'}, {'term': 'Joint pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 142, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9'}, {'term': 'Muscle weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 142, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9'}, {'term': 'Muscle weakness lower limb', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 142, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9'}, {'term': 'Musculoskeletal disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 142, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 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'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 142, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9'}, {'term': 'Encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 142, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 142, 'numEvents': 10, 'numAffected': 9}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9'}, {'term': 'Neurological disorder NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numEvents': 9, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 142, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9'}, {'term': 'Peripheral motor neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 142, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9'}, {'term': 'Peripheral sensory neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 142, 'numEvents': 10, 'numAffected': 8}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 142, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9'}, {'term': 'Taste alteration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numEvents': 4, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 142, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9'}, {'term': 'Tremor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 142, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9'}, {'term': 'Agitation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 142, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 142, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9'}, {'term': 'Confusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 142, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 142, 'numEvents': 8, 'numAffected': 7}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 142, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9'}, {'term': 'Breast pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 142, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9'}, {'term': 'Irregular menstruation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 142, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9'}, {'term': 'Adult respiratory distress syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 142, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9'}, {'term': 'Bronchopulmonary hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 142, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9'}, {'term': 'Bronchospasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 142, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 142, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9'}, {'term': 'Dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 142, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9'}, {'term': 'Hemorrhage nasal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 142, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9'}, {'term': 'Pharyngolaryngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 142, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9'}, {'term': 'Pneumonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 142, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9'}, {'term': 'Respiratory disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 142, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9'}, {'term': 'Voice alteration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 142, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numEvents': 13, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 142, 'numEvents': 14, 'numAffected': 11}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9'}, {'term': 'Hand-and-foot syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 142, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9'}, {'term': 'Nail disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 142, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9'}, {'term': 'Pain of skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 142, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9'}, {'term': 'Rash acneiform', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 142, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9'}, {'term': 'Rash desquamating', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 142, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9'}, {'term': 'Skin disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 142, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9'}, {'term': 'Skin hyperpigmentation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 142, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9'}, {'term': 'Skin ulceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 142, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9'}, {'term': 'Sweating', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 142, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9'}, {'term': 'Hematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 142, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9'}, {'term': 'Hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 142, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9'}, {'term': 'Hot flashes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 142, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 142, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 142, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9'}, {'term': 'Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 142, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'pCR Within the Breast, Defined as no Evidence of Invasive Tumor Remaining in the Breast at Surgery Following Completion of Chemotherapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '138', 'groupId': 'OG000'}, {'value': '142', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FEC-75 Then Paclitaxel/Trastuzumab', 'description': 'Patients receive Fluorouracil, epirubicin, and cyclophosphamide (FEC) comprising fluorouracil IV, epirubicin hydrochloride IV, and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses. Beginning 21 days after completion of FEC, patients receive paclitaxel IV once weekly and trastuzumab (Herceptin) IV once weekly for 12 weeks. Within 6 weeks after completion of paclitaxel and trastuzumab, patients undergo surgery. Beginning 3-4 weeks after surgery, patients receive trastuzumab IV once every 3 weeks for up to 52 weeks. epirubicin hydrochloride: Given IV, cyclophosphamide: Given IV, paclitaxel: Given IV, trastuzumab: Given IV, therapeutic conventional surgery: Undergo surgery, laboratory biomarker analysis: Correlative studies'}, {'id': 'OG001', 'title': 'Paclitaxel/Trastuzumab Then Trastuzumab/FEC-75', 'description': 'Patients receive paclitaxel IV once weekly and trastuzumab IV once weekly for 12 weeks. Beginning 7 days after the completion of paclitaxel and trastuzumab, patients receive FEC comprising fluorouracil IV, epirubicin IV, and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses. Patients also receive trastuzumab IV once weekly for an additional 12 weeks. Within 6 weeks after completion of FEC and trastuzumab, patients undergo surgery. Beginning 3-4 weeks after surgery, patients receive trastuzumab as in arm I. epirubicin hydrochloride: Given IV, cyclophosphamide: Given IV, paclitaxel: Given IV, trastuzumab: Given IV, therapeutic conventional surgery: Undergo surgery, laboratory biomarker analysis: Correlative studies'}], 'classes': [{'categories': [{'measurements': [{'value': '56.5', 'groupId': 'OG000', 'lowerLimit': '47.8', 'upperLimit': '64.9'}, {'value': '54.2', 'groupId': 'OG001', 'lowerLimit': '45.7', 'upperLimit': '62.6'}]}]}], 'analyses': [{'pValue': '.7', 'groupIds': ['OG000', 'OG001'], 'paramType': 'difference in percentages between arms', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.3', 'ciLowerLimit': '-9.3', 'ciUpperLimit': '13.9', 'groupDescription': 'The difference in pCR rates between treatment arms for pCR within the Breast, Defined as no Evidence of Invasive Tumor Remaining in the Breast at Surgery Following Completion of Chemotherapy', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 5 years', 'description': 'Pathological complete response (pCR) rates will be based on institutional pathology reports. In the final analysis for publication, rates will be based on blinded central review of these institutional pathology reports. The Chi-squared test will be conducted at the two-sided 0.05 level. A 95% confidence interval will be computed for the difference in pCR rates.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients who started study treatment are included in the analysis of the primary endpoint.'}, {'type': 'SECONDARY', 'title': 'Combined pCR Rate in the Breast and Axillary Lymph Nodes Defined as no Evidence of Invasive Tumor Remaining in Either the Breast or Axillary Nodes at Surgery Following Completion of Chemotherapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FEC-75 Then Paclitaxel/Trastuzumab', 'description': 'Patients receive Fluorouracil, epirubicin, and cyclophosphamide (FEC) comprising fluorouracil IV, epirubicin hydrochloride IV, and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses. Beginning 21 days after completion of FEC, patients receive paclitaxel IV once weekly and trastuzumab (Herceptin) IV once weekly for 12 weeks. Within 6 weeks after completion of paclitaxel and trastuzumab, patients undergo surgery. Beginning 3-4 weeks after surgery, patients receive trastuzumab IV once every 3 weeks for up to 52 weeks. epirubicin hydrochloride: Given IV, cyclophosphamide: Given IV, paclitaxel: Given IV, trastuzumab: Given IV, therapeutic conventional surgery: Undergo surgery, laboratory biomarker analysis: Correlative studies'}, {'id': 'OG001', 'title': 'Paclitaxel/Trastuzumab Then Trastuzumab/FEC-75', 'description': 'Patients receive paclitaxel IV once weekly and trastuzumab IV once weekly for 12 weeks. Beginning 7 days after the completion of paclitaxel and trastuzumab, patients receive FEC comprising fluorouracil IV, epirubicin IV, and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses. Patients also receive trastuzumab IV once weekly for an additional 12 weeks. Within 6 weeks after completion of FEC and trastuzumab, patients undergo surgery. Beginning 3-4 weeks after surgery, patients receive trastuzumab as in arm I. epirubicin hydrochloride: Given IV, cyclophosphamide: Given IV, paclitaxel: Given IV, trastuzumab: Given IV, therapeutic conventional surgery: Undergo surgery, laboratory biomarker analysis: Correlative studies'}], 'classes': [{'categories': [{'measurements': [{'value': '48.3', 'groupId': 'OG000', 'lowerLimit': '37.6', 'upperLimit': '59.2'}, {'value': '46.7', 'groupId': 'OG001', 'lowerLimit': '36.4', 'upperLimit': '56.9'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 5 years', 'description': 'pCR Rate in the Breast and Axillary Lymph Nodes Defined as no Evidence of Invasive Tumor Remaining in Either the Breast or Axillary Nodes at Surgery Following Completion of Chemotherapy (among those with Metastasis to movable ipsilateral axillary lymph node(s) (cN1-3) disease).', 'unitOfMeasure': 'Percentage (95% confidence Interval)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients who had clinical N1-3 disease prior to the start of treatment are included in the analysis of the pCR rate in the breast and axillary lymph nodes.'}, {'type': 'SECONDARY', 'title': 'Asymptomatic Decreases From Baseline in Left Ventricular Ejection Fraction (LVEF) at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FEC-75 Then Paclitaxel/Trastuzumab', 'description': 'Patients receive Fluorouracil, epirubicin, and cyclophosphamide (FEC) comprising fluorouracil IV, epirubicin hydrochloride IV, and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses. Beginning 21 days after completion of FEC, patients receive paclitaxel IV once weekly and trastuzumab (Herceptin) IV once weekly for 12 weeks. Within 6 weeks after completion of paclitaxel and trastuzumab, patients undergo surgery. Beginning 3-4 weeks after surgery, patients receive trastuzumab IV once every 3 weeks for up to 52 weeks. epirubicin hydrochloride: Given IV, cyclophosphamide: Given IV, paclitaxel: Given IV, trastuzumab: Given IV, therapeutic conventional surgery: Undergo surgery, laboratory biomarker analysis: Correlative studies'}, {'id': 'OG001', 'title': 'Paclitaxel/Trastuzumab Then Trastuzumab/FEC-75', 'description': 'Patients receive paclitaxel IV once weekly and trastuzumab IV once weekly for 12 weeks. Beginning 7 days after the completion of paclitaxel and trastuzumab, patients receive FEC comprising fluorouracil IV, epirubicin IV, and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses. Patients also receive trastuzumab IV once weekly for an additional 12 weeks. Within 6 weeks after completion of FEC and trastuzumab, patients undergo surgery. Beginning 3-4 weeks after surgery, patients receive trastuzumab as in arm I. epirubicin hydrochloride: Given IV, cyclophosphamide: Given IV, paclitaxel: Given IV, trastuzumab: Given IV, therapeutic conventional surgery: Undergo surgery, laboratory biomarker analysis: Correlative studies'}], 'classes': [{'title': 'no decrease or decrease < 10%, still above LLN', 'categories': [{'measurements': [{'value': '92.3', 'groupId': 'OG000'}, {'value': '82.5', 'groupId': 'OG001'}]}]}, {'title': 'decrease < 10%, below lower limit of normal (LLN)', 'categories': [{'measurements': [{'value': '0.8', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'decrease 10-15%, still above lower limit of normal', 'categories': [{'measurements': [{'value': '6.2', 'groupId': 'OG000'}, {'value': '11.7', 'groupId': 'OG001'}]}]}, {'title': 'decrease 10-15%, below lower limit of normal (LLN)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'decrease > 15%, still above lower limit of norm', 'categories': [{'measurements': [{'value': '0.8', 'groupId': 'OG000'}, {'value': '2.9', 'groupId': 'OG001'}]}]}, {'title': 'decrease > 15%, below lower limit of normal', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2.9', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, at 12 week', 'description': 'The summary of asymptomatic decrease in LVEF.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients who had a MUGA or ECHO performed at week 12 are included in the summary of asymptomatic changed in LVEF at week 12.'}, {'type': 'SECONDARY', 'title': 'Asymptomatic Decreases From Baseline in LVEF at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '126', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FEC-75 Then Paclitaxel/Trastuzumab', 'description': 'Patients receive Fluorouracil, epirubicin, and cyclophosphamide (FEC) comprising fluorouracil IV, epirubicin hydrochloride IV, and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses. Beginning 21 days after completion of FEC, patients receive paclitaxel IV once weekly and trastuzumab (Herceptin) IV once weekly for 12 weeks. Within 6 weeks after completion of paclitaxel and trastuzumab, patients undergo surgery. Beginning 3-4 weeks after surgery, patients receive trastuzumab IV once every 3 weeks for up to 52 weeks. epirubicin hydrochloride: Given IV, cyclophosphamide: Given IV, paclitaxel: Given IV, trastuzumab: Given IV, therapeutic conventional surgery: Undergo surgery, laboratory biomarker analysis: Correlative studies'}, {'id': 'OG001', 'title': 'Paclitaxel/Trastuzumab Then Trastuzumab/FEC-75', 'description': 'Patients receive paclitaxel IV once weekly and trastuzumab IV once weekly for 12 weeks. Beginning 7 days after the completion of paclitaxel and trastuzumab, patients receive FEC comprising fluorouracil IV, epirubicin IV, and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses. Patients also receive trastuzumab IV once weekly for an additional 12 weeks. Within 6 weeks after completion of FEC and trastuzumab, patients undergo surgery. Beginning 3-4 weeks after surgery, patients receive trastuzumab as in arm I. epirubicin hydrochloride: Given IV, cyclophosphamide: Given IV, paclitaxel: Given IV, trastuzumab: Given IV, therapeutic conventional surgery: Undergo surgery, laboratory biomarker analysis: Correlative studies'}], 'classes': [{'title': 'no decrease or decrease < 10%, still above LLN', 'categories': [{'measurements': [{'value': '83.3', 'groupId': 'OG000'}, {'value': '73.1', 'groupId': 'OG001'}]}]}, {'title': 'decrease < 10%, below lower limit of normal (LLN)', 'categories': [{'measurements': [{'value': '0.8', 'groupId': 'OG000'}, {'value': '3.1', 'groupId': 'OG001'}]}]}, {'title': 'decrease 10-15%, still above lower limit of normal', 'categories': [{'measurements': [{'value': '7.9', 'groupId': 'OG000'}, {'value': '15.4', 'groupId': 'OG001'}]}]}, {'title': 'decrease 10-15%, below lower limit of normal (LLN)', 'categories': [{'measurements': [{'value': '2.4', 'groupId': 'OG000'}, {'value': '0.8', 'groupId': 'OG001'}]}]}, {'title': 'decrease > 15%, still above lower limit of normal', 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000'}, {'value': '6.9', 'groupId': 'OG001'}]}]}, {'title': 'decrease > 15%, below lower limit of normal (LLN)', 'categories': [{'measurements': [{'value': '4.0', 'groupId': 'OG000'}, {'value': '0.8', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, at 24 week', 'description': 'The summary of asymptomatic changed in LVEF.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients who had a MUGA or ECHO performed at week 24 are included in the summary of asymptomatic changed in LVEF at week 24.'}, {'type': 'SECONDARY', 'title': 'LVEFs From Regularly Scheduled Multi Gated Acquisition Scan (MUGA)/Echo Scans as Reported at 12 Week', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FEC-75 Then Paclitaxel/Trastuzumab', 'description': 'Patients receive Fluorouracil, epirubicin, and cyclophosphamide (FEC) comprising fluorouracil IV, epirubicin hydrochloride IV, and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses. Beginning 21 days after completion of FEC, patients receive paclitaxel IV once weekly and trastuzumab (Herceptin) IV once weekly for 12 weeks. Within 6 weeks after completion of paclitaxel and trastuzumab, patients undergo surgery. Beginning 3-4 weeks after surgery, patients receive trastuzumab IV once every 3 weeks for up to 52 weeks. epirubicin hydrochloride: Given IV, cyclophosphamide: Given IV, paclitaxel: Given IV, trastuzumab: Given IV, therapeutic conventional surgery: Undergo surgery, laboratory biomarker analysis: Correlative studies'}, {'id': 'OG001', 'title': 'Paclitaxel/Trastuzumab Then Trastuzumab/FEC-75', 'description': 'Patients receive paclitaxel IV once weekly and trastuzumab IV once weekly for 12 weeks. Beginning 7 days after the completion of paclitaxel and trastuzumab, patients receive FEC comprising fluorouracil IV, epirubicin IV, and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses. Patients also receive trastuzumab IV once weekly for an additional 12 weeks. Within 6 weeks after completion of FEC and trastuzumab, patients undergo surgery. Beginning 3-4 weeks after surgery, patients receive trastuzumab as in arm I. epirubicin hydrochloride: Given IV, cyclophosphamide: Given IV, paclitaxel: Given IV, trastuzumab: Given IV, therapeutic conventional surgery: Undergo surgery, laboratory biomarker analysis: Correlative studies'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000', 'lowerLimit': '-5', 'upperLimit': '2'}, {'value': '-3', 'groupId': 'OG001', 'lowerLimit': '-7', 'upperLimit': '0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'At 12 week', 'description': 'All patients who had a MUGA or ECHO performed at week 12 are included in the summary of asymptomatic changed in LVEF at week 12. Difference from pretreatment LVEF (%) at 12 weeks \\[median change from baseline Inter Quartile Range (IQR)\\].', 'unitOfMeasure': 'percent', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in LVEFs (From Regularly Scheduled Multi Gated Acquisition Scan (MUGA)/Echo Scans) From Baseline and at 24 Week', 'denoms': [{'units': 'Participants', 'counts': [{'value': '126', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FEC-75 Then Paclitaxel/Trastuzumab', 'description': 'Patients receive Fluorouracil, epirubicin, and cyclophosphamide (FEC) comprising fluorouracil IV, epirubicin hydrochloride IV, and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses. Beginning 21 days after completion of FEC, patients receive paclitaxel IV once weekly and trastuzumab (Herceptin) IV once weekly for 12 weeks. Within 6 weeks after completion of paclitaxel and trastuzumab, patients undergo surgery. Beginning 3-4 weeks after surgery, patients receive trastuzumab IV once every 3 weeks for up to 52 weeks. epirubicin hydrochloride: Given IV, cyclophosphamide: Given IV, paclitaxel: Given IV, trastuzumab: Given IV, therapeutic conventional surgery: Undergo surgery, laboratory biomarker analysis: Correlative studies'}, {'id': 'OG001', 'title': 'Paclitaxel/Trastuzumab Then Trastuzumab/FEC-75', 'description': 'Patients receive paclitaxel IV once weekly and trastuzumab IV once weekly for 12 weeks. Beginning 7 days after the completion of paclitaxel and trastuzumab, patients receive FEC comprising fluorouracil IV, epirubicin IV, and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses. Patients also receive trastuzumab IV once weekly for an additional 12 weeks. Within 6 weeks after completion of FEC and trastuzumab, patients undergo surgery. Beginning 3-4 weeks after surgery, patients receive trastuzumab as in arm I. epirubicin hydrochloride: Given IV, cyclophosphamide: Given IV, paclitaxel: Given IV, trastuzumab: Given IV, therapeutic conventional surgery: Undergo surgery, laboratory biomarker analysis: Correlative studies'}], 'classes': [{'categories': [{'measurements': [{'value': '-3', 'groupId': 'OG000', 'lowerLimit': '-7', 'upperLimit': '0'}, {'value': '-4', 'groupId': 'OG001', 'lowerLimit': '-9', 'upperLimit': '0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, at 24 week', 'description': 'Difference from pretreatment LVEF (%) at 24 weeks \\[median change from baseline Inter Quartile Range (IQR)\\].', 'unitOfMeasure': 'percent', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients who had a MUGA or ECHO performed at week 24 are included in the summary of asymptomatic changed in LVEF at week 24.'}, {'type': 'SECONDARY', 'title': 'Breast Conservation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}, {'value': '138', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FEC-75 Then Paclitaxel/Trastuzumab', 'description': 'Patients receive Fluorouracil, epirubicin, and cyclophosphamide (FEC) comprising fluorouracil IV, epirubicin hydrochloride IV, and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses. Beginning 21 days after completion of FEC, patients receive paclitaxel IV once weekly and trastuzumab (Herceptin) IV once weekly for 12 weeks. Within 6 weeks after completion of paclitaxel and trastuzumab, patients undergo surgery. Beginning 3-4 weeks after surgery, patients receive trastuzumab IV once every 3 weeks for up to 52 weeks. epirubicin hydrochloride: Given IV, cyclophosphamide: Given IV, paclitaxel: Given IV, trastuzumab: Given IV, therapeutic conventional surgery: Undergo surgery, laboratory biomarker analysis: Correlative studies'}, {'id': 'OG001', 'title': 'Paclitaxel/Trastuzumab Then Trastuzumab/FEC-75', 'description': 'Patients receive paclitaxel IV once weekly and trastuzumab IV once weekly for 12 weeks. Beginning 7 days after the completion of paclitaxel and trastuzumab, patients receive FEC comprising fluorouracil IV, epirubicin IV, and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses. Patients also receive trastuzumab IV once weekly for an additional 12 weeks. Within 6 weeks after completion of FEC and trastuzumab, patients undergo surgery. Beginning 3-4 weeks after surgery, patients receive trastuzumab as in arm I. epirubicin hydrochloride: Given IV, cyclophosphamide: Given IV, paclitaxel: Given IV, trastuzumab: Given IV, therapeutic conventional surgery: Undergo surgery, laboratory biomarker analysis: Correlative studies'}], 'classes': [{'categories': [{'measurements': [{'value': '37.7', 'groupId': 'OG000'}, {'value': '39.1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From time surgery to up to 5 years', 'description': 'Surgery was categorized as breast conserving surgery ("Partial Mastectomy") or non-conserving surgery ("Total Mastectomy" or "Modified Radical Mastectomy). Reported below is the percentage of patients receiving "Partial Mastectomy". This was calculated by dividing the number of patients receiving "Partial Mastectomy" by the total number of patients undergoing surgery multiplied by 100 (to obtain the percentage).', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients that underwent breast surgery were included in this analysis.'}, {'type': 'SECONDARY', 'title': 'Disease-free Survival (DFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '138', 'groupId': 'OG000'}, {'value': '142', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FEC-75 Then Paclitaxel/Trastuzumab', 'description': 'Patients receive Fluorouracil, epirubicin, and cyclophosphamide (FEC) comprising fluorouracil IV, epirubicin hydrochloride IV, and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses. Beginning 21 days after completion of FEC, patients receive paclitaxel IV once weekly and trastuzumab (Herceptin) IV once weekly for 12 weeks. Within 6 weeks after completion of paclitaxel and trastuzumab, patients undergo surgery. Beginning 3-4 weeks after surgery, patients receive trastuzumab IV once every 3 weeks for up to 52 weeks. epirubicin hydrochloride: Given IV, cyclophosphamide: Given IV, paclitaxel: Given IV, trastuzumab: Given IV, therapeutic conventional surgery: Undergo surgery, laboratory biomarker analysis: Correlative studies'}, {'id': 'OG001', 'title': 'Paclitaxel/Trastuzumab Then Trastuzumab/FEC-75', 'description': 'Patients receive paclitaxel IV once weekly and trastuzumab IV once weekly for 12 weeks. Beginning 7 days after the completion of paclitaxel and trastuzumab, patients receive FEC comprising fluorouracil IV, epirubicin IV, and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses. Patients also receive trastuzumab IV once weekly for an additional 12 weeks. Within 6 weeks after completion of FEC and trastuzumab, patients undergo surgery. Beginning 3-4 weeks after surgery, patients receive trastuzumab as in arm I. epirubicin hydrochloride: Given IV, cyclophosphamide: Given IV, paclitaxel: Given IV, trastuzumab: Given IV, therapeutic conventional surgery: Undergo surgery, laboratory biomarker analysis: Correlative studies'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Too few events occurred to report a median and 95% Confidence Interval.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Too few events occurred to report a median and 95% Confidence Interval.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From time to registration to time of event, assessed up to 5 years', 'description': 'DFS defined as inoperable progressive disease, gross residual disease following definitive surgery, local, regional or distant recurrence, contralateral breast cancer, other second primary cancers, and death prior to recurrence or second primary cancer. DFS of Arm I and Arm II patients will be estimated using the Kaplan-Meier method.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients that began protocol therapy are included in this analysis'}, {'type': 'SECONDARY', 'title': 'Overall Survival (OS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '138', 'groupId': 'OG000'}, {'value': '142', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FEC-75 Then Paclitaxel/Trastuzumab', 'description': 'Patients receive Fluorouracil, epirubicin, and cyclophosphamide (FEC) comprising fluorouracil IV, epirubicin hydrochloride IV, and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses. Beginning 21 days after completion of FEC, patients receive paclitaxel IV once weekly and trastuzumab (Herceptin) IV once weekly for 12 weeks. Within 6 weeks after completion of paclitaxel and trastuzumab, patients undergo surgery. Beginning 3-4 weeks after surgery, patients receive trastuzumab IV once every 3 weeks for up to 52 weeks. epirubicin hydrochloride: Given IV, cyclophosphamide: Given IV, paclitaxel: Given IV, trastuzumab: Given IV, therapeutic conventional surgery: Undergo surgery, laboratory biomarker analysis: Correlative studies'}, {'id': 'OG001', 'title': 'Paclitaxel/Trastuzumab Then Trastuzumab/FEC-75', 'description': 'Patients receive paclitaxel IV once weekly and trastuzumab IV once weekly for 12 weeks. Beginning 7 days after the completion of paclitaxel and trastuzumab, patients receive FEC comprising fluorouracil IV, epirubicin IV, and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses. Patients also receive trastuzumab IV once weekly for an additional 12 weeks. Within 6 weeks after completion of FEC and trastuzumab, patients undergo surgery. Beginning 3-4 weeks after surgery, patients receive trastuzumab as in arm I. epirubicin hydrochloride: Given IV, cyclophosphamide: Given IV, paclitaxel: Given IV, trastuzumab: Given IV, therapeutic conventional surgery: Undergo surgery, laboratory biomarker analysis: Correlative studies'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Too few events occurred to report a median and 95% Confidence Interval.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Too few events occurred to report a median and 95% Confidence Interval.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From time to registration to death, assessed up to 5 years', 'description': 'OS of Arm I and Arm II patients will be estimated using the Kaplan-Meier method.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients that began protocol therapy were included in this analysis.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'FEC-75 Then Paclitaxel/Trastuzumab', 'description': 'Patients receive FEC comprising fluorouracil IV, epirubicin hydrochloride IV, and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses. Beginning 21 days after completion of FEC, patients receive paclitaxel IV once weekly and trastuzumab (Herceptin) IV once weekly for 12 weeks. Within 6 weeks after completion of paclitaxel and trastuzumab, patients undergo surgery. Beginning 3-4 weeks after surgery, patients receive trastuzumab IV once every 3 weeks for up to 52 weeks. epirubicin hydrochloride: Given IV, cyclophosphamide: Given IV, paclitaxel: Given IV, trastuzumab: Given IV, therapeutic conventional surgery: Undergo surgery, laboratory biomarker analysis: Correlative studies'}, {'id': 'FG001', 'title': 'Paclitaxel/Trastuzumab Then Trastuzumab/FEC-75', 'description': 'Patients receive paclitaxel IV once weekly and trastuzumab IV once weekly for 12 weeks. Beginning 7 days after the completion of paclitaxel and trastuzumab, patients receive FEC comprising fluorouracil IV, epirubicin IV, and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses. Patients also receive trastuzumab IV once weekly for an additional 12 weeks. Within 6 weeks after completion of FEC and trastuzumab, patients undergo surgery. Beginning 3-4 weeks after surgery, patients receive trastuzumab as in arm I. epirubicin hydrochloride: Given IV, cyclophosphamide: Given IV, paclitaxel: Given IV, trastuzumab: Given IV, therapeutic conventional surgery: Undergo surgery, laboratory biomarker analysis: Correlative studies'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '138'}, {'groupId': 'FG001', 'numSubjects': '142'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '138'}, {'groupId': 'FG001', 'numSubjects': '142'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Total Enrolled: 282, 2 patients withdrew consent before starting treatment, 280 patients started the treatment and are eligible for primary analysis.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '138', 'groupId': 'BG000'}, {'value': '142', 'groupId': 'BG001'}, {'value': '280', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'FEC-75 Then Paclitaxel/Trastuzumab', 'description': 'Patients receive FEC comprising fluorouracil IV, epirubicin hydrochloride IV, and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses. Beginning 21 days after completion of FEC, patients receive paclitaxel IV once weekly and trastuzumab (Herceptin) IV once weekly for 12 weeks. Within 6 weeks after completion of paclitaxel and trastuzumab, patients undergo surgery. Beginning 3-4 weeks after surgery, patients receive trastuzumab IV once every 3 weeks for up to 52 weeks. epirubicin hydrochloride: Given IV, cyclophosphamide: Given IV, paclitaxel: Given IV, trastuzumab: Given IV, therapeutic conventional surgery: Undergo surgery, laboratory biomarker analysis: Correlative studies'}, {'id': 'BG001', 'title': 'Paclitaxel/Trastuzumab Then Trastuzumab/FEC-75', 'description': 'Patients receive paclitaxel IV once weekly and trastuzumab IV once weekly for 12 weeks. Beginning 7 days after the completion of paclitaxel and trastuzumab, patients receive FEC comprising fluorouracil IV, epirubicin IV, and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses. Patients also receive trastuzumab IV once weekly for an additional 12 weeks. Within 6 weeks after completion of FEC and trastuzumab, patients undergo surgery. Beginning 3-4 weeks after surgery, patients receive trastuzumab as in arm I. epirubicin hydrochloride: Given IV, cyclophosphamide: Given IV, paclitaxel: Given IV, trastuzumab: Given IV, therapeutic conventional surgery: Undergo surgery, laboratory biomarker analysis: Correlative studies'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '51', 'groupId': 'BG000', 'lowerLimit': '32', 'upperLimit': '76'}, {'value': '48', 'groupId': 'BG001', 'lowerLimit': '28', 'upperLimit': '73'}, {'value': '50', 'groupId': 'BG002', 'lowerLimit': '28', 'upperLimit': '76'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '138', 'groupId': 'BG000'}, {'value': '142', 'groupId': 'BG001'}, {'value': '280', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '138', 'groupId': 'BG000'}, {'value': '142', 'groupId': 'BG001'}, {'value': '280', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Total enrolled: 282, 2 withdrew consent before start of treatment'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 280}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2013-02-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-03', 'studyFirstSubmitDate': '2007-08-06', 'resultsFirstSubmitDate': '2015-07-14', 'studyFirstSubmitQcDate': '2007-08-06', 'lastUpdatePostDateStruct': {'date': '2019-01-23', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2015-08-26', 'studyFirstPostDateStruct': {'date': '2007-08-08', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-09-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'pCR Within the Breast, Defined as no Evidence of Invasive Tumor Remaining in the Breast at Surgery Following Completion of Chemotherapy', 'timeFrame': 'Up to 5 years', 'description': 'Pathological complete response (pCR) rates will be based on institutional pathology reports. In the final analysis for publication, rates will be based on blinded central review of these institutional pathology reports. The Chi-squared test will be conducted at the two-sided 0.05 level. A 95% confidence interval will be computed for the difference in pCR rates.'}], 'secondaryOutcomes': [{'measure': 'Combined pCR Rate in the Breast and Axillary Lymph Nodes Defined as no Evidence of Invasive Tumor Remaining in Either the Breast or Axillary Nodes at Surgery Following Completion of Chemotherapy', 'timeFrame': 'Up to 5 years', 'description': 'pCR Rate in the Breast and Axillary Lymph Nodes Defined as no Evidence of Invasive Tumor Remaining in Either the Breast or Axillary Nodes at Surgery Following Completion of Chemotherapy (among those with Metastasis to movable ipsilateral axillary lymph node(s) (cN1-3) disease).'}, {'measure': 'Asymptomatic Decreases From Baseline in Left Ventricular Ejection Fraction (LVEF) at Week 12', 'timeFrame': 'Baseline, at 12 week', 'description': 'The summary of asymptomatic decrease in LVEF.'}, {'measure': 'Asymptomatic Decreases From Baseline in LVEF at Week 24', 'timeFrame': 'Baseline, at 24 week', 'description': 'The summary of asymptomatic changed in LVEF.'}, {'measure': 'LVEFs From Regularly Scheduled Multi Gated Acquisition Scan (MUGA)/Echo Scans as Reported at 12 Week', 'timeFrame': 'At 12 week', 'description': 'All patients who had a MUGA or ECHO performed at week 12 are included in the summary of asymptomatic changed in LVEF at week 12. Difference from pretreatment LVEF (%) at 12 weeks \\[median change from baseline Inter Quartile Range (IQR)\\].'}, {'measure': 'Change in LVEFs (From Regularly Scheduled Multi Gated Acquisition Scan (MUGA)/Echo Scans) From Baseline and at 24 Week', 'timeFrame': 'Baseline, at 24 week', 'description': 'Difference from pretreatment LVEF (%) at 24 weeks \\[median change from baseline Inter Quartile Range (IQR)\\].'}, {'measure': 'Breast Conservation', 'timeFrame': 'From time surgery to up to 5 years', 'description': 'Surgery was categorized as breast conserving surgery ("Partial Mastectomy") or non-conserving surgery ("Total Mastectomy" or "Modified Radical Mastectomy). Reported below is the percentage of patients receiving "Partial Mastectomy". This was calculated by dividing the number of patients receiving "Partial Mastectomy" by the total number of patients undergoing surgery multiplied by 100 (to obtain the percentage).'}, {'measure': 'Disease-free Survival (DFS)', 'timeFrame': 'From time to registration to time of event, assessed up to 5 years', 'description': 'DFS defined as inoperable progressive disease, gross residual disease following definitive surgery, local, regional or distant recurrence, contralateral breast cancer, other second primary cancers, and death prior to recurrence or second primary cancer. DFS of Arm I and Arm II patients will be estimated using the Kaplan-Meier method.'}, {'measure': 'Overall Survival (OS)', 'timeFrame': 'From time to registration to death, assessed up to 5 years', 'description': 'OS of Arm I and Arm II patients will be estimated using the Kaplan-Meier method.'}]}, 'conditionsModule': {'conditions': ['HER2/Neu Positive', 'Stage IA Breast Cancer', 'Stage IB Breast Cancer', 'Stage II Breast Cancer', 'Stage IIIA Breast Cancer']}, 'referencesModule': {'references': [{'pmid': '30193295', 'type': 'DERIVED', 'citation': 'Buzdar AU, Suman VJ, Meric-Bernstam F, Leitch AM, Ellis MJ, Boughey JC, Unzeitig GW, Royce ME, Hunt KK. Disease-Free and Overall Survival Among Patients With Operable HER2-Positive Breast Cancer Treated With Sequential vs Concurrent Chemotherapy: The ACOSOG Z1041 (Alliance) Randomized Clinical Trial. JAMA Oncol. 2019 Jan 1;5(1):45-50. doi: 10.1001/jamaoncol.2018.3691.'}, {'pmid': '28453704', 'type': 'DERIVED', 'citation': 'Lesurf R, Griffith OL, Griffith M, Hundal J, Trani L, Watson MA, Aft R, Ellis MJ, Ota D, Suman VJ, Meric-Bernstam F, Leitch AM, Boughey JC, Unzeitig G, Buzdar AU, Hunt KK, Mardis ER. Genomic characterization of HER2-positive breast cancer and response to neoadjuvant trastuzumab and chemotherapy-results from the ACOSOG Z1041 (Alliance) trial. Ann Oncol. 2017 May 1;28(5):1070-1077. doi: 10.1093/annonc/mdx048.'}, {'pmid': '24239210', 'type': 'DERIVED', 'citation': 'Buzdar AU, Suman VJ, Meric-Bernstam F, Leitch AM, Ellis MJ, Boughey JC, Unzeitig G, Royce M, McCall LM, Ewer MS, Hunt KK; American College of Surgeons Oncology Group investigators. Fluorouracil, epirubicin, and cyclophosphamide (FEC-75) followed by paclitaxel plus trastuzumab versus paclitaxel plus trastuzumab followed by FEC-75 plus trastuzumab as neoadjuvant treatment for patients with HER2-positive breast cancer (Z1041): a randomised, controlled, phase 3 trial. Lancet Oncol. 2013 Dec;14(13):1317-25. doi: 10.1016/S1470-2045(13)70502-3. Epub 2013 Nov 13.'}]}, 'descriptionModule': {'briefSummary': 'This randomized phase III trial is studying giving fluorouracil together with epirubicin and cyclophosphamide followed by paclitaxel and trastuzumab to see how well it works compared with giving paclitaxel together with trastuzumab followed by fluorouracil, epirubicin, cyclophosphamide, and trastuzumab in treating women with palpable breast cancer that can be removed by surgery. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. It is not yet known whether it is more effective to give combination chemotherapy before or after treatment with paclitaxel plus trastuzumab.', 'detailedDescription': 'PRIMARY OBJECTIVES:\n\nI. The primary objective of this study is to compare the pathologic complete response rate (pCR) within the breast of a sequential regimen of concurrent weekly paclitaxel and trastuzumab, followed by continued weekly trastuzumab administered concurrently with FEC-75 (Arm 2), to the pCR rate of a sequential regimen of FEC-75 alone followed by concurrent weekly paclitaxel and trastuzumab (Arm 1).\n\nSECONDARY OBJECTIVES:\n\nI. To estimate the cardiotoxicity of a sequential regimen of concurrent weekly paclitaxel and trastuzumab, followed by continued weekly trastuzumab administered concurrently with FEC-75, followed postoperatively by q 3 week trastuzumab for a total duration of trastuzumab therapy through 52 weeks from the first dose (Arm 2), and compare the cardiotoxicity to that of a sequential regimen of FEC-75 alone followed by concurrent weekly paclitaxel and trastuzumab, followed by q 3 week trastuzumab for a total duration of trastuzumab therapy through 52 weeks from the first dose (Arm 1).\n\nII. To compare the combined pCR rate in the breast and ipsilateral axilla obtained with the two regimens evaluated in this study.\n\nIII. To compare the clinical response rates (cRR) of the two regimens evaluated in this study.\n\nIV. To compare the non-cardiac toxicity of the two regimens evaluated in this study.\n\nV. To compare breast conservation rates achieved with the two regimens evaluated in this study.\n\nVI. To evaluate disease-free survival and overall survival at 5 years post-randomization.\n\nVII. To correlate pCR rate with potential molecular markers of response.\n\nOUTLINE: Patients are stratified by clinical tumor size (breast tumor size \\< 2 cm and nodal metastases \\< 2 cm vs breast tumor size \\< 2 cm and nodal metastases ≥ 2 cm vs breast tumor size 2-4 cm \\[any nodal status\\] vs breast tumor size ≥ 4 cm \\[any nodal status\\]), age (\\< 50 vs ≥ 50) and hormone receptor status (estrogen receptor \\[ER\\]- and progesterone receptor \\[PgR\\]-negative vs ER- and/or PgR-positive). Patients are randomized to 1 of 2 treatment arms.\n\nARM I: Patients receive FEC comprising fluoroucacil intravenously (IV), epirubicin hydrochloride IV, and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses. Beginning 21 days after completion of FEC, patients receive paclitaxel IV once weekly and trastuzumab (Herceptin) IV once weekly for 12 weeks. Within 6 weeks after completion of paclitaxel and trastuzumab, patients undergo surgery. Beginning 3-4 weeks after surgery, patients receive trastuzumab IV once every 3 weeks for up to 52 weeks.\n\nARM II: Patients receive paclitaxel IV once weekly and trastuzumab IV once weekly for 12 weeks. Beginning 7 days after completion of paclitaxel and trastuzumab, patients receive FEC comprising fluoroucacil IV, epirubicin IV, and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses. Patients also receive trastuzumab IV once weekly for an additional 12 weeks. Within 6 weeks after completion of FEC and trastuzumab, patients undergo surgery. Beginning 3-4 weeks after surgery, patients receive trastuzumab as in arm I.\n\nAfter completion of study therapy, patients are followed every 3 months for 1 year and then every 6 months for 4 years.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Diagnosis of invasive adenocarcinoma by core needle biopsy\n\n * Fine needle aspiration allowed provided primary tumor size \\< 2 cm and lymph node metastases are present\n * Excisional biopsy of the primary tumor allowed provided biopsy-positive lymph nodes are present\n* Primary tumor ≥ 2 cm and/or ≥ 1 biopsy-positive lymph node\n* HER2-positive disease\n\n * Confirmation by fluorescent in situ hybridization (FISH) requires gene amplification\n * Confirmation by immunohistochemistry (IHC) requires a strongly positive (3+) staining intensity score\n* Ductal carcinoma in situ (DCIS) or synchronous DCIS of the contralateral breast regardless of prior therapy allowed\n\n * Synchronous invasive breast cancer not allowed\n* Ipsilateral DCIS treated by local excision with or without hormonal therapy allowed\n\n * Those treated with radiation therapy are not allowed\n* No definitive clinical or radiologic evidence of metastatic disease\n* No history of invasive breast cancer\n* Hormone receptor status known\n* Menopausal status not specified\n* ECOG performance status of 0 -1\n* Absolute neutrophil count ≥ 1,200/mm³\n* Platelet count ≥ 100,000/mm³\n* Total bilirubin normal unless the patient has a grade 1 bilirubin elevation (normal to 1.5 times upper limit of normal \\[ULN\\]) resulting from Gilbert disease or similar syndrome due to slow conjugation of bilirubin\n* Alkaline phosphatase ≤ 2.5 times ULN\n* AST ≤ 1.5 times ULN\n* Creatinine normal\n* Left ventricular ejection fraction (LVEF) ≥ 55 by multi gated acquisition scan (MUGA) or echocardiogram (ECHO) within the past 3 months\n* Patients with either skeletal pain or alkaline phosphatase that is \\> ULN but ≤ 2.5 times ULN allowed if bone scans fail to demonstrate metastatic disease\n\n * Suspicious findings on bone scan must be confirmed as benign by x-ray, MRI, or biopsy\n* Prior non-breast malignancies allowed if disease-free for 5 years since completion of initial treatment regimen and deemed by their physician to be at low risk for recurrence\n\n * Patients who had the following cancers are eligible if diagnosed and treated within the past 5 years:\n\n * Carcinoma in situ of the cervix\n * Colon carcinoma in situ\n * Melanoma in situ\n * Basal cell and squamous cell carcinoma of the skin\n* No cardiac disease that would preclude the use of epirubicin hydrochloride or trastuzumab (Herceptin®) including any of the following:\n\n * Active cardiac disease\n * Angina pectoris that requires the use of antianginal medication\n * Cardiac arrhythmia requiring medication\n * Severe conduction abnormality\n * Clinically significant valvular disease\n * Cardiomegaly on chest x-ray\n * Ventricular hypertrophy on EKG\n * Patient's with poorly controlled hypertension ( i.e., diastolic greater than 100 mm/Hg)\n\n * Patients with hypertension that is well controlled on medication are eligible\n * History of cardiac disease\n * Myocardial infarction documented as a clinical diagnosis or by EKG or any other tests\n * Documented congestive heart failure\n * Documented cardiomyopathy\n* No sensory or motor neuropathy ≥ grade 2, as defined by the NCI's CTCAE v3.0\n* Women of reproductive potential must agree to use an effective non-hormonal method of contraception during therapy\n* Women of child bearing potential must have a negative urine or serum pregnancy test within 2 weeks of registration\n* Not pregnant or nursing\n* No psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the patient from meeting the study requirements\n* No non-malignant systemic disease (e.g., cardiovascular, renal, hepatic) that would preclude treatment with either of the treatment regimens\n* No prior surgical axillary staging procedure\n\n * Prior non-excisional biopsy of an axillary node allowed\n* No prior treatment for this breast cancer\n\n * Hormonal therapy allowed if had been given for up to a total of 28 days anytime after diagnosis and before study entry\n * Hormonal therapy must stop at or before study entry and be re-started, if indicated, following surgery\n* No prior therapy with anthracyclines or taxanes for any malignancy\n* No other investigational agents within the past 30 days\n* No concurrent sex hormonal therapy (e.g., birth control pills, ovarian hormonal replacement therapy)\n* No concurrent therapy with any hormonal agent such as raloxifene, tamoxifen, or other selective estrogen receptor modulator (SERM), either for osteoporosis or breast cancer prevention"}, 'identificationModule': {'nctId': 'NCT00513292', 'briefTitle': 'Combination Chemotherapy and Paclitaxel Plus Trastuzumab in Treating Women With Palpable Breast Cancer That Can Be Removed by Surgery', 'organization': {'class': 'NIH', 'fullName': 'National Cancer Institute (NCI)'}, 'officialTitle': 'A Randomized Phase III Trial Comparing a Neoadjuvant Regimen of FEC-75 Followed by Paclitaxel Plus Trastuzumab With a Neoadjuvant Regimen of Paclitaxel Plus Trastuzumab Followed by FEC-75 Plus Trastuzumab in Patients With HER-2 Positive Operable Breast Cancer', 'orgStudyIdInfo': {'id': 'NCI-2009-00341'}, 'secondaryIdInfos': [{'id': 'NCI-2009-00341', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': 'CDR0000559039'}, {'id': 'ACOSOG-Z1041'}, {'id': 'Z1041', 'type': 'OTHER', 'domain': 'American College of Surgeons Oncology Group'}, {'id': 'ACOSOG-Z1041', 'type': 'OTHER', 'domain': 'CTEP'}, {'id': 'U10CA012027', 'link': 'https://reporter.nih.gov/quickSearch/U10CA012027', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'FEC-75 then Paclitaxel/trastuzumab', 'description': 'Patients receive FEC comprising fluoroucacil IV, epirubicin hydrochloride IV, and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses. Beginning 21 days after completion of FEC, patients receive paclitaxel IV once weekly and trastuzumab (Herceptin) IV once weekly for 12 weeks. Within 6 weeks after completion of paclitaxel and trastuzumab, patients undergo surgery. Beginning 3-4 weeks after surgery, patients receive trastuzumab IV once every 3 weeks for up to 52 weeks.', 'interventionNames': ['Drug: Cyclophosphamide', 'Drug: Epirubicin Hydrochloride', 'Other: Laboratory Biomarker Analysis', 'Drug: Paclitaxel', 'Procedure: Therapeutic Conventional Surgery', 'Biological: Trastuzumab']}, {'type': 'EXPERIMENTAL', 'label': 'Paclitaxel/trastuzumab then trastuzumab/FEC-75', 'description': 'Patients receive paclitaxel IV once weekly and trastuzumab IV once weekly for 12 weeks. Beginning 7 days after the completion of paclitaxel and trastuzumab, patients receive FEC comprising fluoroucacil IV, epirubicin IV, and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses. Patients also receive trastuzumab IV once weekly for an additional 12 weeks. Within 6 weeks after completion of FEC and trastuzumab, patients undergo surgery. Beginning 3-4 weeks after surgery, patients receive trastuzumab as in arm I.', 'interventionNames': ['Drug: Cyclophosphamide', 'Drug: Epirubicin Hydrochloride', 'Other: Laboratory Biomarker Analysis', 'Drug: Paclitaxel', 'Procedure: Therapeutic Conventional Surgery', 'Biological: Trastuzumab']}], 'interventions': [{'name': 'Cyclophosphamide', 'type': 'DRUG', 'otherNames': ['(-)-Cyclophosphamide', '2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroethyl)amino]tetrahydro-, 2-oxide, monohydrate', 'Carloxan', 'Ciclofosfamida', 'Ciclofosfamide', 'Cicloxal', 'Clafen', 'Claphene', 'CP monohydrate', 'CTX', 'CYCLO-cell', 'Cycloblastin', 'Cycloblastine', 'Cyclophospham', 'Cyclophosphamid monohydrate', 'Cyclophosphamidum', 'Cyclophosphan', 'Cyclophosphane', 'Cyclophosphanum', 'Cyclostin', 'Cyclostine', 'Cytophosphan', 'Cytophosphane', 'Cytoxan', 'Fosfaseron', 'Genoxal', 'Genuxal', 'Ledoxina', 'Mitoxan', 'Neosar', 'Revimmune', 'Syklofosfamid', 'WR- 138719'], 'description': 'Given IV', 'armGroupLabels': ['FEC-75 then Paclitaxel/trastuzumab', 'Paclitaxel/trastuzumab then trastuzumab/FEC-75']}, {'name': 'Epirubicin Hydrochloride', 'type': 'DRUG', 'otherNames': ['Ellence', 'IMI-28', 'Pharmorubicin PFS'], 'description': 'Given IV', 'armGroupLabels': ['FEC-75 then Paclitaxel/trastuzumab', 'Paclitaxel/trastuzumab then trastuzumab/FEC-75']}, {'name': 'Laboratory Biomarker Analysis', 'type': 'OTHER', 'description': 'Correlative studies', 'armGroupLabels': ['FEC-75 then Paclitaxel/trastuzumab', 'Paclitaxel/trastuzumab then trastuzumab/FEC-75']}, {'name': 'Paclitaxel', 'type': 'DRUG', 'otherNames': ['Anzatax', 'Asotax', 'Bristaxol', 'Praxel', 'Taxol', 'Taxol Konzentrat'], 'description': 'Given IV', 'armGroupLabels': ['FEC-75 then Paclitaxel/trastuzumab', 'Paclitaxel/trastuzumab then trastuzumab/FEC-75']}, {'name': 'Therapeutic Conventional Surgery', 'type': 'PROCEDURE', 'description': 'Undergo surgery', 'armGroupLabels': ['FEC-75 then Paclitaxel/trastuzumab', 'Paclitaxel/trastuzumab then trastuzumab/FEC-75']}, {'name': 'Trastuzumab', 'type': 'BIOLOGICAL', 'otherNames': ['ABP 980', 'Anti-c-ERB-2', 'Anti-c-erbB2 Monoclonal Antibody', 'Anti-ERB-2', 'Anti-erbB-2', 'Anti-erbB2 Monoclonal Antibody', 'Anti-HER2/c-erbB2 Monoclonal Antibody', 'Anti-p185-HER2', 'c-erb-2 Monoclonal Antibody', 'HER2 Monoclonal Antibody', 'Herceptin', 'Herceptin Biosimilar PF-05280014', 'Herceptin Trastuzumab Biosimilar PF-05280014', 'MoAb HER2', 'Monoclonal Antibody c-erb-2', 'Monoclonal Antibody HER2', 'PF-05280014', 'rhuMAb HER2', 'Trastuzumab Biosimilar ABP 980', 'Trastuzumab Biosimilar PF-05280014'], 'description': 'Given IV', 'armGroupLabels': ['FEC-75 then Paclitaxel/trastuzumab', 'Paclitaxel/trastuzumab then trastuzumab/FEC-75']}]}, 'contactsLocationsModule': {'locations': [{'zip': '36688', 'city': 'Mobile', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of South Alabama Mitchell Cancer Institute', 'geoPoint': {'lat': 30.69436, 'lon': -88.04305}}, {'zip': '94546', 'city': 'Castro Valley', 'state': 'California', 'country': 'United States', 'facility': 'Eden Hospital Medical Center', 'geoPoint': {'lat': 37.6941, 'lon': -122.08635}}, {'zip': '94904', 'city': 'Greenbrae', 'state': 'California', 'country': 'United States', 'facility': 'Marin Cancer Care Inc', 'geoPoint': {'lat': 37.94854, 'lon': -122.5247}}, {'zip': '94545', 'city': 'Hayward', 'state': 'California', 'country': 'United States', 'facility': 'Saint Rose Hospital', 'geoPoint': {'lat': 37.66882, 'lon': -122.0808}}, {'zip': '94588', 'city': 'Pleasanton', 'state': 'California', 'country': 'United States', 'facility': 'Valley Care Health System - Pleasanton', 'geoPoint': {'lat': 37.66243, 'lon': -121.87468}}, {'zip': '94588', 'city': 'Pleasanton', 'state': 'California', 'country': 'United States', 'facility': 'Valley Medical Oncology Consultants', 'geoPoint': {'lat': 37.66243, 'lon': -121.87468}}, {'zip': '33756', 'city': 'Clearwater', 'state': 'Florida', 'country': 'United States', 'facility': 'Morton Plant Hospital', 'geoPoint': {'lat': 27.96585, 'lon': -82.8001}}, {'zip': '33316', 'city': 'Fort Lauderdale', 'state': 'Florida', 'country': 'United States', 'facility': 'Broward Health Medical Center', 'geoPoint': {'lat': 26.12231, 'lon': -80.14338}}, {'zip': '33805', 'city': 'Lakeland', 'state': 'Florida', 'country': 'United States', 'facility': 'Lakeland Regional Cancer Center', 'geoPoint': {'lat': 28.03947, 'lon': -81.9498}}, {'zip': '30501', 'city': 'Gainesville', 'state': 'Georgia', 'country': 'United States', 'facility': 'Northeast Georgia Medical Center', 'geoPoint': {'lat': 34.29788, 'lon': -83.82407}}, {'zip': '60631', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Presence Resurrection Medical Center', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '46107', 'city': 'Beech Grove', 'state': 'Indiana', 'country': 'United States', 'facility': 'Saint Francis Hospital and Health Centers', 'geoPoint': {'lat': 39.72199, 'lon': -86.08998}}, {'zip': '46237', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Franciscan Saint Francis Health-Indianapolis', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '47374', 'city': 'Richmond', 'state': 'Indiana', 'country': 'United States', 'facility': 'Reid Hospital and Health Care Services', 'geoPoint': {'lat': 39.82894, 'lon': -84.89024}}, {'zip': '51101', 'city': 'Sioux City', 'state': 'Iowa', 'country': 'United States', 'facility': 'Siouxland Regional Cancer Center', 'geoPoint': {'lat': 42.49999, 'lon': -96.40031}}, {'zip': '51104', 'city': 'Sioux City', 'state': 'Iowa', 'country': 'United States', 'facility': 'Mercy Medical Center-Sioux City', 'geoPoint': {'lat': 42.49999, 'lon': -96.40031}}, {'zip': '51104', 'city': 'Sioux City', 'state': 'Iowa', 'country': 'United States', 'facility': "Saint Luke's Regional Medical Center", 'geoPoint': {'lat': 42.49999, 'lon': -96.40031}}, {'zip': '66720', 'city': 'Chanute', 'state': 'Kansas', 'country': 'United States', 'facility': 'Cancer Center of Kansas - Chanute', 'geoPoint': {'lat': 37.67921, 'lon': -95.4572}}, {'zip': '67801', 'city': 'Dodge City', 'state': 'Kansas', 'country': 'United States', 'facility': 'Cancer Center of Kansas - Dodge City', 'geoPoint': {'lat': 37.7528, 'lon': -100.01708}}, {'zip': '67042', 'city': 'El Dorado', 'state': 'Kansas', 'country': 'United States', 'facility': 'Cancer Center of Kansas - El Dorado', 'geoPoint': {'lat': 37.81724, 'lon': -96.86225}}, {'zip': '66701', 'city': 'Fort Scott', 'state': 'Kansas', 'country': 'United States', 'facility': 'Cancer Center of Kansas - Fort Scott', 'geoPoint': {'lat': 37.83976, 'lon': -94.7083}}, {'zip': '67301', 'city': 'Independence', 'state': 'Kansas', 'country': 'United States', 'facility': 'Cancer Center of Kansas-Independence', 'geoPoint': {'lat': 37.22424, 'lon': -95.70831}}, {'zip': '67068', 'city': 'Kingman', 'state': 'Kansas', 'country': 'United States', 'facility': 'Cancer Center of Kansas-Kingman', 'geoPoint': {'lat': 37.64585, 'lon': -98.11367}}, {'zip': '66044', 'city': 'Lawrence', 'state': 'Kansas', 'country': 'United States', 'facility': 'Lawrence Memorial Hospital', 'geoPoint': {'lat': 38.97167, 'lon': -95.23525}}, {'zip': '67901', 'city': 'Liberal', 'state': 'Kansas', 'country': 'United States', 'facility': 'Cancer Center of Kansas-Liberal', 'geoPoint': {'lat': 37.04308, 'lon': -100.921}}, {'zip': '67114', 'city': 'Newton', 'state': 'Kansas', 'country': 'United States', 'facility': 'Cancer Center of Kansas - 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