Ignite Creation Date:
2025-12-24 @ 3:36 PM
Ignite Modification Date:
2026-01-02 @ 4:09 AM
Study NCT ID:
NCT00856492
Status:
COMPLETED
Last Update Posted:
2017-06-27
First Post:
2009-03-04
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
S0800, Nab-Paclitaxel, Doxorubicin, Cyclophosphamide, and Pegfilgrastim With or Without Bevacizumab in Treating Women With Inflammatory or Locally Advanced 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'}], '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': 'D000068258', 'term': 'Bevacizumab'}, {'id': 'C455861', 'term': 'pegfilgrastim'}, {'id': 'D003520', 'term': 'Cyclophosphamide'}, {'id': 'D004317', 'term': 'Doxorubicin'}, {'id': 'D013660', 'term': 'Taxes'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}, {'id': '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': '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': 'D004467', 'term': 'Economics'}, {'id': 'D004472', 'term': 'Health Care Economics and Organizations'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '206-667-4623', 'title': 'Breast Committee Statistician', 'organization': 'SWOG Statistical Center'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up to 25 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Arm I (Nab-Paclitaxel + Bevacizumab - AC+PEG-G))', 'description': 'Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on day 1 and bevacizumab IV over 30- to 90-minutes on day 1 of weeks 1-12. Patients then receive doxorubicin hydrochloride IV and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 2 of weeks 14, 16, 18, 20, 22, and 24.', 'otherNumAtRisk': 96, 'otherNumAffected': 92, 'seriousNumAtRisk': 96, 'seriousNumAffected': 22}, {'id': 'EG001', 'title': 'Arm II (Nab-Paclitaxel - AC+PEG-G)', 'description': 'Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on day 1 of weeks 1-12. Patients then receive doxorubicin hydrochloride IV and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 2 of weeks 14, 16, 18, 20, 22, and 24.', 'otherNumAtRisk': 60, 'otherNumAffected': 58, 'seriousNumAtRisk': 60, 'seriousNumAffected': 3}, {'id': 'EG002', 'title': 'Arm III (AC+PEG-G - Nab-Paclitaxel)', 'description': 'Patients receive doxorubicin hydrochloride IV and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 2 of weeks 1, 3, 5, 7, 9, and 11. Patients then receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on day 1 of weeks 14-25.', 'otherNumAtRisk': 51, 'otherNumAffected': 50, 'seriousNumAtRisk': 51, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numAffected': 73}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 43}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 48}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Sinus tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Ear pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 4}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Blurred vision', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 5}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 4}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dry eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 3}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Eye disorders-Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Watering eyes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 11}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Anal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bloating', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numAffected': 52}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 24}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 26}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numAffected': 46}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 31}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 27}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 15}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastroesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastrointestinal disorders-Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Mucositis oral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numAffected': 42}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 26}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 29}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numAffected': 73}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 49}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 41}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Oral pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Rectal hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Stomach pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numAffected': 35}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 32}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 28}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 8}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Edema limbs', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 9}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numAffected': 85}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 50}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 45}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 12}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Flu like symptoms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 23}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 10}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bronchial infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Infections and infestations-Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Lung infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nail infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Skin infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Tooth infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Upper respiratory infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 16}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 16}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 19}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'CD4 lymphocytes decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Investigations-Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Lymphocyte count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 8}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numAffected': 58}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 24}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 26}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 13}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Weight loss', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 13}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'White blood cell decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numAffected': 48}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 22}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 29}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Anorexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numAffected': 35}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 19}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 20}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 7}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hyperglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 19}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypertriglyceridemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypoalbuminemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 11}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypocalcemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 5}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypoglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 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{'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 11}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 13}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 7}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bone pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 13}], 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'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Skin infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Ejection fraction decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Investigations-Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Weight gain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'White blood cell decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hyperglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypokalemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hyponatremia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Neoplasms benign, malignant and unspecified - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Peripheral sensory neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Reversible posterior leukoencephalopathy syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Confusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Adult respiratory distress syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pneumonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Thromboembolic event', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Patients With Pathological Complete Response Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1 (Nab-Paclitaxel + Bevacizumab - AC+PEG-G))', 'description': 'Received intravenous (IV) administration of nabpaclitaxel 100 mg/m2 IV weekly for 12 weeks (nP x 12) with IV bevacizumab 10 mg/kg every 2 weeks (six doses), followed by IV doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2 with pegfilgrastim 6 mg subcutaneously every 2 weeks for six cycles (ddAC x 6).'}, {'id': 'OG001', 'title': 'Arm 2/3 (Nab-Paclitaxel/AC+PEG-G))', 'description': 'Received nP x 12 followed by ddAC x 6, or received ddAC x 6 first followed by nP x 12, without bevacizumab'}], 'classes': [{'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.019', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'pre-study pathology vs. post-chemo surgery pathology (approx. 39-42 weeks post-randomization)', 'description': 'Pathologic complete response (pCR), commonly defined as the absence of residual invasive cancer in both the breast and axillary lymph nodes, has emerged as a surrogate endpoint for disease-free and overall survival, as the achievement of a pCR is associated with a favorable long-term prognosis in all breast cancer subtypes.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Pre-specified analysis of Arm 1 vs. Arm 2/3 to compare effect of bevacizumab'}, {'type': 'SECONDARY', 'title': 'Overall Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1 (Nab-Paclitaxel + Bevacizumab - AC+PEG-G))', 'description': 'Received intravenous (IV) administration of nabpaclitaxel 100 mg/m2 IV weekly for 12 weeks (nP x 12) with IV bevacizumab 10 mg/kg every 2 weeks (six doses), followed by IV doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2 with pegfilgrastim 6 mg subcutaneously every 2 weeks for six cycles (ddAC x 6).'}, {'id': 'OG001', 'title': 'Arm 2/3 (Nab-Paclitaxel/AC+PEG-G))', 'description': 'Arm II received nP x 12 followed by ddAC x 6, and those randomized to Arm III received ddAC x 6 first followed by nP x 12, both without bevacizumab'}], 'classes': [{'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.64', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Disease assessed every 4 weeks while on treatment then every 6 months for one year then annually for four years from registration.', 'description': 'Time from registration to death due to any cause', 'unitOfMeasure': 'deaths', 'reportingStatus': 'POSTED', 'populationDescription': 'Pre-specified analysis of Arm 1 vs. Arm 2/3 to compare effect of bevacizumab'}, {'type': 'SECONDARY', 'title': 'Event-free Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1 (Nab-Paclitaxel + Bevacizumab - AC+PEG-G))', 'description': 'Received intravenous (IV) administration of nabpaclitaxel 100 mg/m2 IV weekly for 12 weeks (nP x 12) with IV bevacizumab 10 mg/kg every 2 weeks (six doses), followed by IV doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2 with pegfilgrastim 6 mg subcutaneously every 2 weeks for six cycles (ddAC x 6).'}, {'id': 'OG001', 'title': 'Arm 2/3 (Nab-Paclitaxel/AC+PEG-G))', 'description': 'Received nP x 12 followed by ddAC x 6, or received ddAC x 6 first followed by nP x 12, without bevacizumab'}], 'classes': [{'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.71', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Disease assessed every 4 weeks while on treatment then every 6 months for one year then annually for four years from registration or until recurrence', 'description': 'Time from registration to first instance of any of the following events: progression prior to surgery, recurrence post-surgery or death from any cause.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Pre-specified analysis of Arm 1 vs. Arm 2/3 to compare effect of bevacizumab'}, {'type': 'SECONDARY', 'title': 'Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I (Nab-Paclitaxel + Bevacizumab - AC+PEG-G))', 'description': 'Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on day 1 and bevacizumab IV over 30- to 90-minutes on day 1 of weeks 1-12. Patients then receive doxorubicin hydrochloride IV and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 2 of weeks 14, 16, 18, 20, 22, and 24.'}, {'id': 'OG001', 'title': 'Arm II (Nab-Paclitaxel - AC+PEG-G)', 'description': 'Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on day 1 of weeks 1-12. Patients then receive doxorubicin hydrochloride IV and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 2 of weeks 14, 16, 18, 20, 22, and 24.'}, {'id': 'OG002', 'title': 'Arm III (AC+PEG-G - Nab-Paclitaxel)', 'description': 'Patients receive doxorubicin hydrochloride IV and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 2 of weeks 1, 3, 5, 7, 9, and 11. Patients then receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on day 1 of weeks 14-25.'}], 'classes': [{'title': 'Abdominal pain', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Adult respiratory distress syndrome', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Alanine aminotransferase increased', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Anemia', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}]}, {'title': 'Anorectal infection', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Anxiety', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Aspartate aminotransferase increased', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Blood and lymphatic system disorders - Other', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Bone pain', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'CD4 lymphocytes decreased', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Catheter related infection', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Chest wall pain', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Confusion', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Conjunctivitis', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Dehydration', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Dental caries', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Depression', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Device related infection', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Diarrhea', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Dysphagia', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Dyspnea', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Ear pain', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Edema limbs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Ejection fraction decreased', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Enterocolitis', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Enterocolitis infectious', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Erythema multiforme', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Facial nerve disorder', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Facial pain', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Fatigue', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}, {'title': 'Febrile neutropenia', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'Gait disturbance', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Gastrointestinal disorders - Other, specify', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Generalized muscle weakness', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Headache', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Heart failure', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Hypercalcemia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Hyperglycemia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}, {'title': 'Hypertension', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Hypokalemia', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'Hyponatremia', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Hypophosphatemia', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Hypotension', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Insomnia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Leukocytosis', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Lung infection', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Lymphocyte count decreased', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Mucositis oral', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}, {'title': 'Myalgia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Nasal congestion', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Nausea', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}, {'title': 'Neutrophil count decreased', 'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}]}]}, {'title': 'Non-cardiac chest pain', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Oral pain', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Otitis externa', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Pain', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Pain in extremity', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Palmar-plantar erythrodysesthesia syndrome', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Periorbital infection', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Peripheral motor neuropathy', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Peripheral sensory neuropathy', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Platelet count decreased', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Pneumonitis', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Proctitis', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Proteinuria', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Rash maculo-papular', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Rectal pain', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Renal and urinary disorders - Other, specify', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Respiratory failure', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Sepsis', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Skin and subcutaneous tissue disorders - Other', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Skin infection', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Suicide attempt', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Syncope', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Thromboembolic event', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Tooth infection', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Urinary tract infection', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Vomiting', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Vulval infection', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Weight gain', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Weight loss', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'White blood cell decreased', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 28 weeks', 'description': 'Only adverse events that are possibly, probably or definitely related to study drug are reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants receiving at least some protocol treatment'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Arm 1 (Nab-Paclitaxel + Bevacizumab / AC+PEG-G))', 'description': 'Received intravenous (IV) administration of nabpaclitaxel 100 mg/m2 IV weekly for 12 weeks (nP x 12) with IV bevacizumab 10 mg/kg every 2 weeks (six doses), followed by IV doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2 with pegfilgrastim 6 mg subcutaneously every 2 weeks for six cycles (ddAC x 6).'}, {'id': 'FG001', 'title': 'Arm 2 (Nab-Paclitaxel / AC+PEG-G)', 'description': 'Received nP x 12 without bevacizumab followed by ddAC x 6'}, {'id': 'FG002', 'title': 'Arm 3 (AC+PEG-G / Nab-Paclitaxel)', 'description': 'ddAC x 6 followed by nP x 12 without bevacizumab'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '99'}, {'groupId': 'FG001', 'numSubjects': '63'}, {'groupId': 'FG002', 'numSubjects': '53'}]}, {'type': 'Toxicity Eval', 'comment': 'Fewer pts evaluable for toxicity vs arm totals b/c 2 pts on each arm did not receive any treatment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '96'}, {'groupId': 'FG001', 'numSubjects': '60'}, {'groupId': 'FG002', 'numSubjects': '51'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '98'}, {'groupId': 'FG001', 'numSubjects': '62'}, {'groupId': 'FG002', 'numSubjects': '51'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Ineligible or withdrew consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'BG000'}, {'value': '62', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}, {'value': '211', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Arm 1 (Nab-Paclitaxel + Bevacizumab / AC+PEG-G)', 'description': 'Received intravenous (IV) administration of nabpaclitaxel 100 mg/m2 IV weekly for 12 weeks (nP x 12) with IV bevacizumab 10 mg/kg every 2 weeks (six doses), followed by IV doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2 with pegfilgrastim 6 mg subcutaneously every 2 weeks for six cycles (ddAC x 6).'}, {'id': 'BG001', 'title': 'Arm 2 (Nab-Paclitaxel / AC+PEG-G))', 'description': 'Received nP x 12 followed by ddAC x 6 without bevacizumab'}, {'id': 'BG002', 'title': 'Arm 3 (AC+PEG-G / Nab-Paclitaxel)', 'description': 'Received ddAC x 6 first followed by nP x 12, without bevacizumab'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'BG000'}, {'value': '62', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}, {'value': '211', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '51.7', 'groupId': 'BG000', 'lowerLimit': '22', 'upperLimit': '71'}, {'value': '49.7', 'groupId': 'BG001', 'lowerLimit': '33', 'upperLimit': '75'}, {'value': '51.6', 'groupId': 'BG002', 'lowerLimit': '31', 'upperLimit': '66'}, {'value': '51.5', 'groupId': 'BG003', 'lowerLimit': '22', 'upperLimit': '75'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'BG000'}, {'value': '62', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}, {'value': '211', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '98', 'groupId': 'BG000'}, {'value': '62', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}, {'value': '211', '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': 'Race/Ethnicity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'BG000'}, {'value': '62', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}, {'value': '211', 'groupId': 'BG003'}]}], 'categories': [{'title': 'White', 'measurements': [{'value': '70', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}, {'value': '154', 'groupId': 'BG003'}]}, {'title': 'Black', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '38', 'groupId': 'BG003'}]}, {'title': 'Asian/Pacific Islander', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}]}, {'title': 'Other/unknown', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Inflammatory Breast Cancer (IBC) or Non-IBC Locally Advanced Breast Cancer (LABC)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'BG000'}, {'value': '62', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}, {'value': '211', 'groupId': 'BG003'}]}], 'categories': [{'title': 'IBC', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}]}, {'title': 'Non-IBC LABC', 'measurements': [{'value': '88', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}, {'value': '187', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Hormone receptor status', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'BG000'}, {'value': '62', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}, {'value': '211', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Positive: ER+ or PgR+', 'measurements': [{'value': '66', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}, {'value': '144', 'groupId': 'BG003'}]}, {'title': 'Negative: ER- and PR- (TNBC)', 'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}, {'value': '67', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Breast cancer stage', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'BG000'}, {'value': '62', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}, {'value': '210', 'groupId': 'BG003'}]}], 'categories': [{'title': 'IIB', 'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}, {'value': '87', 'groupId': 'BG003'}]}, {'title': 'IIIA', 'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '62', 'groupId': 'BG003'}]}, {'title': 'IIIB', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '53', 'groupId': 'BG003'}]}, {'title': 'IIIC', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Measure Description: As per AJCC 6th ed, 2002:\n\nhttps://cancerstaging.org/references-tools/deskreferences/Documents/AJCC6thEdCancerStagingManualPart2.pdf', 'unitOfMeasure': 'Participants', 'populationDescription': 'One subject missing Breast cancer stage information at baseline.'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 215}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-23', 'studyFirstSubmitDate': '2009-03-04', 'resultsFirstSubmitDate': '2016-11-15', 'studyFirstSubmitQcDate': '2009-03-04', 'lastUpdatePostDateStruct': {'date': '2017-06-27', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-05-23', 'studyFirstPostDateStruct': {'date': '2009-03-05', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-06-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Patients With Pathological Complete Response Rate', 'timeFrame': 'pre-study pathology vs. post-chemo surgery pathology (approx. 39-42 weeks post-randomization)', 'description': 'Pathologic complete response (pCR), commonly defined as the absence of residual invasive cancer in both the breast and axillary lymph nodes, has emerged as a surrogate endpoint for disease-free and overall survival, as the achievement of a pCR is associated with a favorable long-term prognosis in all breast cancer subtypes.'}], 'secondaryOutcomes': [{'measure': 'Overall Survival', 'timeFrame': 'Disease assessed every 4 weeks while on treatment then every 6 months for one year then annually for four years from registration.', 'description': 'Time from registration to death due to any cause'}, {'measure': 'Event-free Survival', 'timeFrame': 'Disease assessed every 4 weeks while on treatment then every 6 months for one year then annually for four years from registration or until recurrence', 'description': 'Time from registration to first instance of any of the following events: progression prior to surgery, recurrence post-surgery or death from any cause.'}, {'measure': 'Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug', 'timeFrame': 'Up to 28 weeks', 'description': 'Only adverse events that are possibly, probably or definitely related to study drug are reported.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['inflammatory breast cancer', 'stage II breast cancer', 'stage IIIA breast cancer', 'stage IIIB breast cancer', 'HER2-negative breast cancer', 'estrogen receptor-negative breast cancer', 'estrogen receptor-positive breast cancer', 'progesterone receptor-negative breast cancer', 'progesterone receptor-positive breast cancer', 'stage IIIC breast cancer'], 'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle formulation, doxorubicin, and cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Colony-stimulating factors, such as pegfilgrastim, may increase the number of immune cells found in bone marrow or peripheral blood and may help the immune system recover from the side effects of chemotherapy. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some find tumor cells and kill them or carry tumor-killing substances to them. Others interfere with the ability of tumor cells to grow and spread. Bevacizumab may also may stop the growth of tumor cells by blocking blood flow to the tumor. Giving these treatments before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. It is not yet known which treatment regimen is more effective in treating women with breast cancer.\n\nPURPOSE: This randomized phase II trial is studying paclitaxel albumin-stabilized nanoparticle formulation, doxorubicin, cyclophosphamide, and pegfilgrastim to compare how well they work when given with or without bevacizumab in treating women with inflammatory or locally advanced breast cancer.', 'detailedDescription': 'OBJECTIVES:\n\n* To compare the pathologic complete response rates in women with HER2/neu-negative inflammatory or locally advanced breast cancer treated with paclitaxel albumin-stabilized nanoparticle formulation, doxorubicin hydrochloride, cyclophosphamide, and pegfilgrastim with vs without bevacizumab.\n* To compare the overall survival of patients treated with these regimens.\n* To assess whether there is a correlation between bevacizumab and stratification factors (type of disease and hormone receptor status).\n* To compare the toxicities of these regimens.\n* To explore the molecular biomarkers related to the biology and outcome of inflammatory breast cancer.\n* To explore potential molecular biomarkers that predict response to therapy and drug sensitivity.\n* To evaluate biomarkers with respect to the sequence of paclitaxel albumin-stabilized nanoparticle formulation and doxorubicin hydrochloride/cyclophosphamide/pegfilgrastim administration in patients not receiving bevacizumab.\n* To explore residual cancer burden and correlate it with outcome.\n* To evaluate the time to treatment failure prior to surgery.\n* To evaluate disease-free survival from the time of surgery in patients undergoing definitive surgery.\n\nOUTLINE: This is a multicenter study. Patients are stratified according to type of disease (inflammatory vs locally advanced breast cancer) and hormone receptor status (positive \\[estrogen receptor (ER)+ and/or progesterone receptor (PgR)+\\] vs negative \\[ER- and PgR-\\]). Patients are randomized to 1 of 3 treatment arms.\n\n* Arm I: Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on day 1 and bevacizumab IV over 30- to 90-minutes on day 1 of weeks 1-12. Patients then receive doxorubicin hydrochloride IV and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 2 of weeks 14, 16, 18, 20, 22, and 24.\n* Arm II: Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on day 1 of weeks 1-12. Patients then receive doxorubicin hydrochloride IV and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 2 of weeks 14, 16, 18, 20, 22, and 24.\n* Arm III: Patients receive doxorubicin hydrochloride IV and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 2 of weeks 1, 3, 5, 7, 9, and 11. Patients then receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on day 1 of weeks 14-25.\n\nIn all arms, patients with stable or responding disease undergo surgery 3-6 weeks after completion of chemotherapy. Patients may then undergo radiotherapy 5 days a week for 6 weeks.\n\nSerum, whole blood, and tissue samples are collected periodically for biomarker analysis, circulating endothelial cell analysis, and pharmacogenomic studies, respectively.\n\nAfter completion of study treatment, patients are followed every 6 months for 1 year and then annually for 4 years.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "DISEASE CHARACTERISTICS:\n\n* Histologically or pathologically confirmed breast cancer meeting one of the following criteria:\n\n * Locally advanced disease (stage IIIB disease, stage IIB/IIIA, or stage IIIC disease)\n * Inflammatory disease meeting the following two clinicopathologic criteria:\n\n * Diffuse erythema AND edema (peau d'orange) of the breast involving the majority of the skin of the breast, i.e., more than 50%\n * A biopsy demonstrating cancer either within the dermal lymphatics OR in the breast parenchyma itself\n* HER2/neu-negative tumor as demonstrated by 0 or 1+ (weak or no staining) by DAKO, IHC, or equivalent test OR no gene amplification by FISH\\*\n\n * 2+ by DAKO or IHC allowed provided FISH\\* negative\n* NOTE: \\*A negative FISH test ratio is \\< 1.8 or FISH HER2 gene copy \\< 4.0; if only a positive or negative result is available from the FISH test, a negative result is acceptable for study entry\n* Hormone receptor status known\n\nPATIENT CHARACTERISTICS:\n\n* Menopausal status not specified\n* Zubrod performance status 0-2\n* Granulocyte count \\> 1,500/mm\\^3\n* ANC ≥ 1,500/mm\\^3\n* Platelet count \\> 100,000/mm\\^3\n* Hemoglobin 9.0 g/dL\n* Serum creatinine ≤ 1.5 times upper limit of normal (ULN)\n* Bilirubin ≤ 1.5 mg/dL\n* ALT and AST ≤ 3 times ULN\n* Alkaline phosphatase ≤ 2.5 ULN (unless bone metastasis is present in the absence of liver metastasis)\n* Urine protein:creatinine ratio ≤ 0.5 OR urine protein \\< 1,000 mg on 24-hour urine collection\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective contraception\n* Able to take oral medications (e.g., no uncontrolled nausea, vomiting, or diarrhea, lack of physical integrity of the upper gastrointestinal tract, or malabsorption syndrome)\n* QTc \\< 500 msec by EKG\n* LVEF normal by MUGA or ECHO (for patients with hypertension or for patients \\> 60 years of age)\n* NYHA class II cardiac function by baseline ECHO/MUGA (for patients who have received central thoracic radiotherapy that included the heart in the radiotherapy port, or for patients who have a history of class II heart failure but are asymptomatic on treatment are eligible)\n* No history of stroke (cerebrovascular accident), transient ischemic attack, or cardiac event within the past 12 months, including any of the following:\n\n * Myocardial infarction (including severe/unstable angina)\n * Coronary/peripheral artery bypass graft\n * Symptomatic congestive heart failure\n * Pulmonary embolism\n* No poorly controlled hypertension, defined as recurrent or persistent (≥ 24 hours) elevated blood pressure (i.e., systolic blood pressure ≥ 140 mm Hg and/or diastolic blood pressure ≥ 90 mm Hg)\n* No other malignancy within the past 5 years except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer\n* Peripheral neuropathy \\< grade 2\n\nPRIOR CONCURRENT THERAPY:\n\n* No prior tyrosine kinase inhibitors\n* More than 5 years since prior chemotherapy, radiotherapy, or biologic therapy (e.g., trastuzumab or bevacizumab) for invasive breast cancer\n* At least 7 days since prior hormonal therapy\n* At least 7 days since prior and no concurrent strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, atazanavir, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, voriconazole) or grapefruit juice\n* No concurrent CYP3A4 inducers (e.g., dexamethasone, phenytoin, carbamazepine, rifampin, rifabutin, rifapentin, phenobarbital, St. John's wort)\n* No other concurrent therapy for the treatment of breast cancer except for bisphosphonates\n* No concurrent brachytherapy"}, 'identificationModule': {'nctId': 'NCT00856492', 'briefTitle': 'S0800, Nab-Paclitaxel, Doxorubicin, Cyclophosphamide, and Pegfilgrastim With or Without Bevacizumab in Treating Women With Inflammatory or Locally Advanced Breast Cancer', 'organization': {'class': 'NETWORK', 'fullName': 'SWOG Cancer Research Network'}, 'officialTitle': 'A Randomized Phase II Trial of Weekly Nanoparticle Albumin Bound Paclitaxel (Nab-Paclitaxel) (NSC-736631) With or Without Bevacizumab, Either Preceded by or Followed by Q 2 Week Doxorubicin (A)and Cyclophosphamide (C) Plus Pegfilgrastim (PEG-G) as Neoadjuvant Therapy For Inflammatory and Locally Advanced HER-2/NEU Negative Breast Cancer', 'orgStudyIdInfo': {'id': 'CDR0000636131'}, 'secondaryIdInfos': [{'id': 'S0800', 'type': 'OTHER', 'domain': 'SWOG'}, {'id': 'U10CA032102', 'link': 'https://reporter.nih.gov/quickSearch/U10CA032102', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm 1', 'description': 'Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on day 1 and bevacizumab IV over 30- to 90-minutes on day 1 of weeks 1-12. Patients then receive doxorubicin hydrochloride IV and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 2 of weeks 14, 16, 18, 20, 22, and 24.', 'interventionNames': ['Biological: bevacizumab', 'Biological: pegfilgrastim', 'Drug: cyclophosphamide', 'Drug: doxorubicin hydrochloride', 'Drug: paclitaxel albumin-stabilized nanoparticle formulation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arm 2', 'description': 'Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on day 1 of weeks 1-12, and then receive doxorubicin hydrochloride IV and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 2 of weeks 14, 16, 18, 20, 22, and 24.', 'interventionNames': ['Biological: pegfilgrastim', 'Drug: cyclophosphamide', 'Drug: doxorubicin hydrochloride', 'Drug: paclitaxel albumin-stabilized nanoparticle formulation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arm 3', 'description': 'Patients receive doxorubicin hydrochloride IV and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 2 of weeks 1, 3, 5, 7, 9, and 11, and then receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on day 1 of weeks 14-25.', 'interventionNames': ['Biological: pegfilgrastim', 'Drug: cyclophosphamide', 'Drug: doxorubicin hydrochloride', 'Drug: paclitaxel albumin-stabilized nanoparticle formulation']}], 'interventions': [{'name': 'bevacizumab', 'type': 'BIOLOGICAL', 'description': 'Given IV', 'armGroupLabels': ['Arm 1']}, {'name': 'pegfilgrastim', 'type': 'BIOLOGICAL', 'description': 'Given subcutaneously', 'armGroupLabels': ['Arm 1', 'Arm 2', 'Arm 3']}, {'name': 'cyclophosphamide', 'type': 'DRUG', 'description': 'Given IV', 'armGroupLabels': ['Arm 1', 'Arm 2', 'Arm 3']}, {'name': 'doxorubicin hydrochloride', 'type': 'DRUG', 'description': 'Given IV', 'armGroupLabels': ['Arm 1', 'Arm 2', 'Arm 3']}, {'name': 'paclitaxel albumin-stabilized nanoparticle formulation', 'type': 'DRUG', 'description': 'Given IV', 'armGroupLabels': ['Arm 1', 'Arm 2', 'Arm 3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '36608', 'city': 'Mobile', 'state': 'Alabama', 'country': 'United States', 'facility': 'Providence Cancer Center at Providence Hospital', 'geoPoint': {'lat': 30.69436, 'lon': -88.04305}}, {'zip': '72205', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Arkansas Cancer Research Center at University of Arkansas for Medical Sciences', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '94704', 'city': 'Berkeley', 'state': 'California', 'country': 'United States', 'facility': 'Alta Bates Summit Comprehensive Cancer Center', 'geoPoint': {'lat': 37.87159, 'lon': -122.27275}}, {'zip': '91505', 'city': 'Burbank', 'state': 'California', 'country': 'United States', 'facility': 'Roy and Patricia Disney Family Cancer Center at Providence Saint Joseph Medical Center', 'geoPoint': {'lat': 34.18084, 'lon': -118.30897}}, {'zip': '94010', 'city': 'Burlingame', 'state': 'California', 'country': 'United States', 'facility': 'Peninsula Medical Center', 'geoPoint': {'lat': 37.5841, 'lon': -122.36608}}, {'zip': '94546', 'city': 'Castro Valley', 'state': 'California', 'country': 'United States', 'facility': 'East Bay Radiation Oncology Center', 'geoPoint': {'lat': 37.6941, 'lon': -122.08635}}, {'zip': '94546', 'city': 'Castro Valley', 'state': 'California', 'country': 'United States', 'facility': 'Valley Medical Oncology Consultants - 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