Ignite Creation Date:
2025-12-25 @ 1:25 AM
Ignite Modification Date:
2025-12-26 @ 6:07 AM
Study NCT ID:
NCT00295893
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-09-25
First Post:
2006-02-23
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Combination Chemotherapy With or Without Trastuzumab in Treating Patients With Stage II or Stage III Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D058922', 'term': 'Inflammatory Breast Neoplasms'}, {'id': 'D018567', 'term': 'Breast Neoplasms, Male'}, {'id': 'D018270', 'term': 'Carcinoma, Ductal, Breast'}, {'id': 'D018275', 'term': 'Carcinoma, Lobular'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D044584', 'term': 'Carcinoma, Ductal'}, {'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D018299', 'term': 'Neoplasms, Ductal, Lobular, and Medullary'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003520', 'term': 'Cyclophosphamide'}, {'id': 'D000077143', 'term': 'Docetaxel'}, {'id': 'D004317', 'term': 'Doxorubicin'}, {'id': 'D000068878', 'term': 'Trastuzumab'}, {'id': 'D016190', 'term': 'Carboplatin'}, {'id': 'D017239', 'term': 'Paclitaxel'}], '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': 'D043823', 'term': 'Taxoids'}, {'id': 'D043822', 'term': 'Cyclodecanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D003630', 'term': 'Daunorubicin'}, {'id': 'D018943', 'term': 'Anthracyclines'}, {'id': 'D009279', 'term': 'Naphthacenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D000617', 'term': 'Aminoglycosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}, {'id': 'D056831', 'term': 'Coordination Complexes'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'pfrankel@coh.org', 'phone': '626-218-5265', 'title': 'Paul Frankel, Ph.D.', 'organization': 'City of Hope'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events occurred over a period of 2 years and 7 months.', 'description': '"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.', 'eventGroups': [{'id': 'EG000', 'title': 'Docetaxel, Doxorubicin Hydrochloride, and Cyclophosphamide', 'description': 'Patients receive 50 mg/m2 doxorubicin hydrochloride IV, 500 mg/m2 cyclophosphamide IV, and 75 mg/m2 docetaxel IV on day 1. Treatment repeats every 21 days for 6 courses.', 'otherNumAtRisk': 37, 'deathsNumAtRisk': 37, 'otherNumAffected': 37, 'seriousNumAtRisk': 37, 'deathsNumAffected': 2, 'seriousNumAffected': 8}, {'id': 'EG001', 'title': 'Doxorubicin Hydrochloride and Cyclophosphamide Followed by Paclitaxel and Carboplatin', 'description': 'Patients receive 60 mg/m2 doxorubicin hydrochloride IV and 600 mg/m2 cyclophosphamide IV on day 1; treatment repeats every 2 weeks for 4 courses. Patients then receive AUC 2 carboplatin IV on day 1 and 100 mg/m2 paclitaxel IV on days 1, 8, and 15; treatment with carboplatin and paclitaxel repeats every 4 weeks for 3 courses.', 'otherNumAtRisk': 40, 'deathsNumAtRisk': 40, 'otherNumAffected': 40, 'seriousNumAtRisk': 40, 'deathsNumAffected': 4, 'seriousNumAffected': 5}, {'id': 'EG002', 'title': 'Doxorubicin Hydrochloride and Cyclophosphamide Followed by Paclitaxel, Carboplatin and Trastuzumab', 'description': 'Patients receive chemotherapy as in arm II. They also receive 2 mg/m2 trastuzumab (Herceptin®) IV weekly, beginning with the first doses of paclitaxel and carboplatin.', 'otherNumAtRisk': 44, 'deathsNumAtRisk': 44, 'otherNumAffected': 44, 'seriousNumAtRisk': 44, 'deathsNumAffected': 4, 'seriousNumAffected': 8}], 'otherEvents': [{'term': 'Blood disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra10.0'}, {'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra10.0'}, {'term': 'Hemoglobin decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 126, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 177, 'numAffected': 39}, {'groupId': 'EG002', 'numAtRisk': 44, 'numEvents': 197, 'numAffected': 43}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra10.0'}, {'term': 'Hemolysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra10.0'}, {'term': 'Lymph node pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra10.0'}, {'term': 'Lymphatic disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 44, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra9.0'}, {'term': 'Arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 44, 'numEvents': 5, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra9.0'}, {'term': 'Atrial tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 6, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 44, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra10.0'}, {'term': 'Cardiac disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra9.0'}, {'term': 'Left ventricular failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 44, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra9.0'}, {'term': 'Myocardial ischemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra10.0'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 44, 'numEvents': 11, 'numAffected': 9}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra10.0'}, {'term': 'Pericardial effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra10.0'}, {'term': 'Premature ventricular contractions', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra9.0'}, {'term': 'Restrictive cardiomyopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra10.0'}, {'term': 'Sinus arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra10.0'}, {'term': 'Sinus bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra9.0'}, {'term': 'Sinus tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 25, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 60, 'numAffected': 22}, {'groupId': 'EG002', 'numAtRisk': 44, 'numEvents': 45, 'numAffected': 22}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra10.0'}, {'term': 'Supraventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 44, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra9.0'}, {'term': 'Ventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra10.0'}, {'term': 'Ventricular trigeminy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra9.0'}, {'term': 'Ear disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra10.0'}, {'term': 'Ear pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra10.0'}, {'term': 'External ear pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 44, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra9.0'}, {'term': 'Hearing loss', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra10.0'}, {'term': 'Tinnitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 44, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra10.0'}, {'term': 'Cushingoid', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra10.0'}, {'term': 'Endocrine disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra10.0'}, {'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra9.0'}, {'term': 'Dry eye syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 44, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra10.0'}, {'term': 'Eye disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 44, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra10.0'}, {'term': 'Eye pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 44, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra10.0'}, {'term': 'Flashing vision', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra9.0'}, {'term': 'Photophobia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra10.0'}, {'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 11, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 44, 'numEvents': 19, 'numAffected': 10}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra10.0'}, {'term': 'Watering eyes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 8, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 8, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 44, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra10.0'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 44, 'numEvents': 14, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra10.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 12, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 11, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 44, 'numEvents': 22, 'numAffected': 14}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra10.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 30, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 60, 'numAffected': 23}, {'groupId': 'EG002', 'numAtRisk': 44, 'numEvents': 78, 'numAffected': 35}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra10.0'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 31, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 30, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 44, 'numEvents': 39, 'numAffected': 22}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra10.0'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 44, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 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'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra10.0'}, {'term': 'Serum potassium decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra10.0'}, {'term': 'Serum sodium decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 44, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra10.0'}, {'term': 'Treatment related secondary malignancy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra10.0'}, {'term': 'Cognitive disturbance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra10.0'}, {'term': 'Depressed level of consciousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra10.0'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra10.0'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra10.0'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra10.0'}, {'term': 'Psychosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra10.0'}, {'term': 'Urogenital disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra10.0'}, {'term': 'Dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 44, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra10.0'}, {'term': 'Rash desquamating', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra10.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Count of Patients With Pathologic Complete Response (pCR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '44', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Docetaxel, Doxorubicin Hydrochloride, and Cyclophosphamide', 'description': 'Patients receive 50 mg/m2 doxorubicin hydrochloride IV, 500 mg/m2 cyclophosphamide IV, and 75 mg/m2 docetaxel IV on day 1. Treatment repeats every 21 days for 6 courses.'}, {'id': 'OG001', 'title': 'Doxorubicin Hydrochloride and Cyclophosphamide Followed by Paclitaxel and Carboplatin', 'description': 'Patients receive 60 mg/m2 doxorubicin hydrochloride IV and 600 mg/m2 cyclophosphamide IV on day 1; treatment repeats every 2 weeks for 4 courses. Patients then receive AUC 2 carboplatin IV on day 1 and 100 mg/m2 paclitaxel IV on days 1, 8, and 15; treatment with carboplatin and paclitaxel repeats every 4 weeks for 3 courses.'}, {'id': 'OG002', 'title': 'Doxorubicin Hydrochloride and Cyclophosphamide Followed by Paclitaxel, Carboplatin and Trastuzumab', 'description': 'Patients receive chemotherapy as in arm II. They also receive 2 mg/m2 trastuzumab (Herceptin®) IV weekly, beginning with the first doses of paclitaxel and carboplatin.'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At the time of surgery within 4 weeks of the end of chemotherapy, up to 10 months', 'description': 'pCR was defined as no evidence of residual invasive cancer (or very few scattered tumor cells) in primary tumor and lymph nodes.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Count of Patients With Residual Cancer Burden (RCB) Scores of 0 or 1.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '44', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Docetaxel, Doxorubicin Hydrochloride, and Cyclophosphamide', 'description': 'Patients receive 50 mg/m2 doxorubicin hydrochloride IV, 500 mg/m2 cyclophosphamide IV, and 75 mg/m2 docetaxel IV on day 1. Treatment repeats every 21 days for 6 courses.'}, {'id': 'OG001', 'title': 'Doxorubicin Hydrochloride and Cyclophosphamide Followed by Paclitaxel and Carboplatin', 'description': 'Patients receive 60 mg/m2 doxorubicin hydrochloride IV and 600 mg/m2 cyclophosphamide IV on day 1; treatment repeats every 2 weeks for 4 courses. Patients then receive AUC 2 carboplatin IV on day 1 and 100 mg/m2 paclitaxel IV on days 1, 8, and 15; treatment with carboplatin and paclitaxel repeats every 4 weeks for 3 courses.'}, {'id': 'OG002', 'title': 'Doxorubicin Hydrochloride and Cyclophosphamide Followed by Paclitaxel, Carboplatin and Trastuzumab', 'description': 'Patients receive chemotherapy as in arm II. They also receive 2 mg/m2 trastuzumab (Herceptin®) IV weekly, beginning with the first doses of paclitaxel and carboplatin.'}], 'classes': [{'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At the time of surgery within 4 weeks of the end of chemotherapy, up to 10 months.', 'description': 'RCB score is determined using information on the size of the tumor and the extent of tumor cells in the breast and axillary lymph nodes after neoadjuvant therapy. The higher the RCB score, the more residual breast cancer there is in the breast and lymph nodes:\n\nRCB-0 = No residual breast cancer RCB-I = Small amount of residual breast cancer RCB-II = Moderate amount of residual breast cancer RCB-III = Extensive (a lot of) residual breast cancer', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Docetaxel, Doxorubicin Hydrochloride, and Cyclophosphamide', 'description': 'Patients receive 50mg/m2 doxorubicin hydrochloride IV, 500 mg/m2 cyclophosphamide IV, and 75 mg/m2 docetaxel IV on day 1. Treatment repeats every 21 days for 6 courses.'}, {'id': 'FG001', 'title': 'Doxorubicin Hydrochloride and Cyclophosphamide Followed by Paclitaxel and Carboplatin', 'description': 'Patients receive 60 mg/m2 doxorubicin hydrochloride IV and 600 mg/m2 cyclophosphamide IV on day 1; treatment repeats every 2 weeks for 4 courses. Patients then receive AUC 2 carboplatin IV on day 1 and 100 mg/m2 paclitaxel IV on days 1, 8, and 15; treatment with carboplatin and paclitaxel repeats every 4 weeks for 3 courses.'}, {'id': 'FG002', 'title': 'Doxorubicin Hydrochloride and Cyclophosphamide Followed by Paclitaxel, Carboplatin and Trastuzumab', 'description': 'Patients receive chemotherapy as in arm II. They also receive 2 mg/kg trastuzumab (Herceptin®) IV weekly, beginning with the first doses of paclitaxel and carboplatin.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '37'}, {'groupId': 'FG001', 'numSubjects': '40'}, {'groupId': 'FG002', 'numSubjects': '44'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '37'}, {'groupId': 'FG001', 'numSubjects': '40'}, {'groupId': 'FG002', 'numSubjects': '44'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}, {'value': '121', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Docetaxel, Doxorubicin Hydrochloride, and Cyclophosphamide', 'description': 'Patients receive 50 mg/m2 doxorubicin hydrochloride IV, 500 mg/m2 cyclophosphamide IV, and 75 mg/m2 docetaxel IV on day 1. Treatment repeats every 21 days for 6 courses.'}, {'id': 'BG001', 'title': 'Doxorubicin Hydrochloride and Cyclophosphamide Followed by Paclitaxel and Carboplatin', 'description': 'Patients receive 60 mg/m2 doxorubicin hydrochloride IV and 600 mg/m2 cyclophosphamide IV on day 1; treatment repeats every 2 weeks for 4 courses. Patients then receive AUC 2 carboplatin IV on day 1 and paclitaxel IV on days 1, 8, and 15; treatment with carboplatin and 100 mg/m2 paclitaxel repeats every 4 weeks for 3 courses.'}, {'id': 'BG002', 'title': 'Doxorubicin Hydrochloride and Cyclophosphamide Followed by Paclitaxel, Carboplatin and Trastuzumab', 'description': 'Patients receive chemotherapy as in arm II. They also receive 2 mg/kg trastuzumab (Herceptin®) IV weekly, beginning with the first doses of paclitaxel and carboplatin.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '50', 'groupId': 'BG000', 'lowerLimit': '33', 'upperLimit': '65'}, {'value': '49', 'groupId': 'BG001', 'lowerLimit': '31', 'upperLimit': '68'}, {'value': '52', 'groupId': 'BG002', 'lowerLimit': '30', 'upperLimit': '70'}, {'value': '50', 'groupId': 'BG003', 'lowerLimit': '30', 'upperLimit': '70'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}, {'value': '121', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'American Native', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}]}]}, {'title': 'African American', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}, {'value': '55', 'groupId': 'BG003'}]}]}, {'title': 'Hispanic', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '45', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}, {'value': '121', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2009-03-17', 'size': 843137, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-03-31T02:37', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 121}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2005-09-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-08-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-14', 'studyFirstSubmitDate': '2006-02-23', 'resultsFirstSubmitDate': '2022-03-31', 'studyFirstSubmitQcDate': '2006-02-23', 'lastUpdatePostDateStruct': {'date': '2025-09-25', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2023-03-10', 'studyFirstPostDateStruct': {'date': '2006-02-24', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2023-03-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2013-12-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Count of Patients With Pathologic Complete Response (pCR)', 'timeFrame': 'At the time of surgery within 4 weeks of the end of chemotherapy, up to 10 months', 'description': 'pCR was defined as no evidence of residual invasive cancer (or very few scattered tumor cells) in primary tumor and lymph nodes.'}, {'measure': 'Count of Patients With Residual Cancer Burden (RCB) Scores of 0 or 1.', 'timeFrame': 'At the time of surgery within 4 weeks of the end of chemotherapy, up to 10 months.', 'description': 'RCB score is determined using information on the size of the tumor and the extent of tumor cells in the breast and axillary lymph nodes after neoadjuvant therapy. The higher the RCB score, the more residual breast cancer there is in the breast and lymph nodes:\n\nRCB-0 = No residual breast cancer RCB-I = Small amount of residual breast cancer RCB-II = Moderate amount of residual breast cancer RCB-III = Extensive (a lot of) residual breast cancer'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['inflammatory breast cancer', 'stage II breast cancer', 'stage IIIA breast cancer', 'stage IIIB breast cancer', 'stage IIIC breast cancer', 'male breast cancer', 'Paget disease of the breast with invasive ductal carcinoma', 'invasive ductal breast carcinoma with predominant intraductal component', 'invasive ductal breast carcinoma', 'medullary ductal breast carcinoma with lymphocytic infiltrate', 'comedo ductal breast carcinoma', 'invasive lobular breast carcinoma with predominant in situ component', 'invasive lobular breast carcinoma', 'mucinous ductal breast carcinoma', 'papillary ductal breast carcinoma', 'tubular ductal breast carcinoma'], 'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'RATIONALE: 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. Giving more than one drug (combination chemotherapy) may kill more tumor cells. 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. Giving combination chemotherapy with or without trastuzumab before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. It is not yet known whether combination chemotherapy is more effective with or without trastuzumab in treating breast cancer.\n\nPURPOSE: This randomized phase II trial is comparing two different regimens of combination chemotherapy given together with or without trastuzumab to see how well they work in treating patients with stage II or stage III breast cancer.', 'detailedDescription': 'OBJECTIVES:\n\nPrimary\n\n* Compare 2 neoadjuvant chemotherapy regimens (docetaxel, doxorubicin hydrochloride, and cyclophosphamide \\[TAC\\] vs doxorubicin and cyclophosphamide followed by paclitaxel and carboplatin \\[ACAC\\]), in terms of toxicities and effectiveness as defined by the pathological complete remission rate, in patients with non HER2/neu overexpressing stage II or III breast cancer.\n* Evaluate the probability of achieving a pathological complete remission when adding trastuzumab (Herceptin®) to ACAC in the subset of patients with HER2/neu overexpressing stage II or III breast cancer.\n\nSecondary\n\n* Identify prognostic and predictive markers of outcome, recurrence, and targets of therapy.\n\nOUTLINE: This is a randomized study. Patients with non HER2/neu overexpressing tumors are randomized to 1 of 2 treatment arms. Patients with HER2/neu overexpressing tumors are assigned to arm III.\n\n* Arm I: Patients receive doxorubicin hydrochloride IV, cyclophosphamide IV, and docetaxel IV on day 1. Treatment repeats every 21 days for 6 courses.\n* Arm II: Patients receive doxorubicin hydrochloride IV and cyclophosphamide IV on day 1; treatment repeats every 2 weeks for 4 courses. Patients then receive carboplatin IV on day 1 and paclitaxel IV on days 1, 8, and 15; treatment with carboplatin and paclitaxel repeats every 4 weeks for 3 courses.\n* Arm III: Patients receive chemotherapy as in arm II. They also receive trastuzumab (Herceptin®) IV weekly, beginning with the first doses of paclitaxel and carboplatin.\n\nWithin 4 weeks after completion of chemotherapy with or without trastuzumab (Herceptin®), all patients undergo surgery.\n\nPROJECTED ACCRUAL: A total of 105 patients will be accrued for this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '120 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "DISEASE CHARACTERISTICS:\n\n* Histologically proven infiltrating ductal or lobular breast carcinoma\n\n * Stage II or III disease\n * Inflammatory breast cancer allowed\n* Hormone-receptor status not specified\n\nPATIENT CHARACTERISTICS:\n\n* ECOG performance status \\< 2\n* Male or female\n* Menopausal status not specified (for female patients)\n* Absolute neutrophil count ≥ 1,500/mm\\^3\n* Platelet count ≥ 100,000/mm\\^3\n* Bilirubin normal (except for patient's with Gilbert's disease)\n* Creatinine ≤ 1.2 mg/dL\n* Creatinine clearance ≥ 70 mL/min\n* Ejection fraction ≥ 50% on MUGA\n* No neuropathy ≥ grade 1\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective nonhormonal contraception\n* No prior malignant disease within the past 5 years, excluding:\n\n * Squamous cell or basal cell skin carcinoma\n * Stage I or in situ cervical carcinoma\n* No noninvasive (in situ) breast carcinoma within the past 5 years\n\nPRIOR CONCURRENT THERAPY:\n\n* At least 5 years since prior antiestrogen treatment for any indication other than breast cancer prevention (tamoxifen, raloxifene, or an aromatase inhibitor)\n* No prior radiotherapy to the chest wall"}, 'identificationModule': {'nctId': 'NCT00295893', 'briefTitle': 'Combination Chemotherapy With or Without Trastuzumab in Treating Patients With Stage II or Stage III Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'City of Hope Medical Center'}, 'officialTitle': 'Randomized Phase II Study of Docetaxel, Adriamycin, and Cytoxan (TAC) Versus Adriamycin/Cytoxan, Followed by Abraxane/Carboplatin (ACAC) +/- Trastuzumab as Neoadjuvant Therapy for Patients With Stage II-III Breast Cancer', 'orgStudyIdInfo': {'id': '05015'}, 'secondaryIdInfos': [{'id': 'P30CA033572', 'link': 'https://reporter.nih.gov/quickSearch/P30CA033572', 'type': 'NIH'}, {'id': 'CDR0000455631', 'type': 'REGISTRY', 'domain': 'PDQ'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Docetaxel, Doxorubicin Hydrochloride, and Cyclophosphamide', 'description': 'Patients receive doxorubicin hydrochloride IV, cyclophosphamide IV, and docetaxel IV on day 1. Treatment repeats every 21 days for 6 courses.', 'interventionNames': ['Drug: cyclophosphamide', 'Drug: docetaxel', 'Drug: doxorubicin hydrochloride']}, {'type': 'EXPERIMENTAL', 'label': 'Doxorubicin Hydrochloride and Cyclophosphamide Followed by Paclitaxel and Carboplatin', 'description': 'Patients receive doxorubicin hydrochloride IV and cyclophosphamide IV on day 1; treatment repeats every 2 weeks for 4 courses. Patients then receive carboplatin IV on day 1 and paclitaxel IV on days 1, 8, and 15; treatment with carboplatin and paclitaxel repeats every 4 weeks for 3 courses.', 'interventionNames': ['Drug: cyclophosphamide', 'Drug: doxorubicin hydrochloride', 'Drug: Carboplatin', 'Drug: Paclitaxel']}, {'type': 'EXPERIMENTAL', 'label': 'Doxorubicin Hydrochloride and Cyclophosphamide Followed by Paclitaxel, Carboplatin and trastuzumab', 'description': 'Patients receive chemotherapy as in arm II. They also receive trastuzumab (Herceptin®) IV weekly, beginning with the first doses of paclitaxel and carboplatin.', 'interventionNames': ['Drug: cyclophosphamide', 'Drug: doxorubicin hydrochloride', 'Biological: Trastuzumab', 'Drug: Carboplatin', 'Drug: Paclitaxel']}], 'interventions': [{'name': 'cyclophosphamide', 'type': 'DRUG', 'description': 'Given IV', 'armGroupLabels': ['Docetaxel, Doxorubicin Hydrochloride, and Cyclophosphamide', 'Doxorubicin Hydrochloride and Cyclophosphamide Followed by Paclitaxel and Carboplatin', 'Doxorubicin Hydrochloride and Cyclophosphamide Followed by Paclitaxel, Carboplatin and trastuzumab']}, {'name': 'docetaxel', 'type': 'DRUG', 'description': 'Given IV', 'armGroupLabels': ['Docetaxel, Doxorubicin Hydrochloride, and Cyclophosphamide']}, {'name': 'doxorubicin hydrochloride', 'type': 'DRUG', 'description': 'Given IV', 'armGroupLabels': ['Docetaxel, Doxorubicin Hydrochloride, and Cyclophosphamide', 'Doxorubicin Hydrochloride and Cyclophosphamide Followed by Paclitaxel and Carboplatin', 'Doxorubicin Hydrochloride and Cyclophosphamide Followed by Paclitaxel, Carboplatin and trastuzumab']}, {'name': 'Trastuzumab', 'type': 'BIOLOGICAL', 'description': 'Given IV', 'armGroupLabels': ['Doxorubicin Hydrochloride and Cyclophosphamide Followed by Paclitaxel, Carboplatin and trastuzumab']}, {'name': 'Carboplatin', 'type': 'DRUG', 'description': 'Given IV', 'armGroupLabels': ['Doxorubicin Hydrochloride and Cyclophosphamide Followed by Paclitaxel and Carboplatin', 'Doxorubicin Hydrochloride and Cyclophosphamide Followed by Paclitaxel, Carboplatin and trastuzumab']}, {'name': 'Paclitaxel', 'type': 'DRUG', 'description': 'Given IV', 'armGroupLabels': ['Doxorubicin Hydrochloride and Cyclophosphamide Followed by Paclitaxel and Carboplatin', 'Doxorubicin Hydrochloride and Cyclophosphamide Followed by Paclitaxel, Carboplatin and trastuzumab']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91010-3000', 'city': 'Duarte', 'state': 'California', 'country': 'United States', 'facility': 'City of Hope Medical Center', 'geoPoint': {'lat': 34.13945, 'lon': -117.97729}}], 'overallOfficials': [{'name': 'Joanne Mortimer, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'City of Hope Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'City of Hope Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}