Ignite Creation Date:
2025-12-25 @ 2:33 AM
Ignite Modification Date:
2025-12-31 @ 8:15 PM
Study NCT ID:
NCT00121134
Status:
COMPLETED
Last Update Posted:
2013-12-24
First Post:
2005-07-13
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Bevacizumab With or Without Cyclophosphamide and Methotrexate: A Pilot Study in Women With Operable Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068258', 'term': 'Bevacizumab'}, {'id': 'D003520', 'term': 'Cyclophosphamide'}, {'id': 'D008727', 'term': 'Methotrexate'}, {'id': 'D000069287', 'term': 'Capecitabine'}], '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': 'D000630', 'term': 'Aminopterin'}, {'id': 'D011622', 'term': 'Pterins'}, {'id': 'D011621', 'term': 'Pteridines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D005472', 'term': 'Fluorouracil'}, {'id': 'D014498', 'term': 'Uracil'}, {'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D003853', 'term': 'Deoxyribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'hal_burstein@dfci.harvard.edu', 'phone': '617-632-3800', 'title': 'Dr Harold J. Burstein', 'organization': 'DFCI'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Group A- Bevacizumab Alone', 'description': 'Bevacizumab 15 mg/kg every 3 wks for 1 year', 'otherNumAtRisk': 40, 'otherNumAffected': 40, 'seriousNumAtRisk': 40, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Group B-Bevacizumab+Cyclophosphamide+Methotrexate', 'description': 'Bevacizumab 15 mg/kg every 3 weeks for 1 year +Cyclophosphamide 50 mg orally daily for 6 months +methotrexate 2.5mg orally on day 1-2 each week for 6 months.', 'otherNumAtRisk': 41, 'otherNumAffected': 41, 'seriousNumAtRisk': 41, 'seriousNumAffected': 3}, {'id': 'EG002', 'title': 'Group C-Bevacizumab + Capcitabine(18 Wks)', 'description': 'capecitabine 2000 mg/m2/day 14 days on/7 days off for 18 weeks, and bevacizumab 15 mg/kg every 3 weeks for 1 year', 'otherNumAtRisk': 41, 'otherNumAffected': 41, 'seriousNumAtRisk': 41, 'seriousNumAffected': 1}, {'id': 'EG003', 'title': 'Group D-bevacizumab + Capecitibine (24wks)', 'description': 'capecitabine 2000 mg orally twice per day for 7 days on/7 days off for 24 weeks, and bevacizumab 15 mg/kg every 3 weeks for 1 year.', 'otherNumAtRisk': 40, 'otherNumAffected': 40, 'seriousNumAtRisk': 40, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'ALT, SGPT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 6, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 41, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 40, 'numEvents': 7, 'numAffected': 3}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCTCAE v.3'}, {'term': 'AST, SGOT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 17, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 41, 'numEvents': 42, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 12, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 40, 'numEvents': 9, 'numAffected': 3}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCTCAE v.3'}, {'term': 'Abdomen, pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 10, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 41, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 15, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCTCAE v.3'}, {'term': 'Alkaline phosphatase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 12, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 41, 'numEvents': 10, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 40, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCTCAE v.3'}, {'term': 'Allergic rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 17, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 40, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCTCAE v.3'}, {'term': 'Agitation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numEvents': 4, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 40, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCTCAE v.3'}, {'term': 'Allergic Reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 40, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCTCAE v.3'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 41, 'numEvents': 9, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 6, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 40, 'numEvents': 5, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCTCAE v.3'}, {'term': 'Anorexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 12, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 41, 'numEvents': 12, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 14, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 40, 'numEvents': 15, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCTCAE v.3'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 33, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 41, 'numEvents': 20, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 34, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 40, 'numEvents': 15, 'numAffected': 7}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCTCAE v.3'}, {'term': 'Arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numEvents': 7, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 40, 'numEvents': 9, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCTCAE v.3'}, {'term': 'back,pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 16, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 41, 'numEvents': 31, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 34, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 40, 'numEvents': 13, 'numAffected': 6}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCTCAE v.3'}, {'term': 'bicarbonate', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numEvents': 11, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCTCAE v.3'}, {'term': 'bilirubin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 40, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCTCAE v.3'}, {'term': 'bone, pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 7, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 41, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 12, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 40, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCTCAE v.3'}, {'term': 'breast,pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 12, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 41, 'numEvents': 22, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 14, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCTCAE v.3'}, {'term': 'bruising', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 12, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 41, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 11, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 40, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCTCAE v.3'}, {'term': 'buttock, pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 40, 'numEvents': 8, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCTCAE v.3'}, {'term': 'Chelitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCTCAE v.3'}, {'term': 'chest wall, pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 13, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 41, 'numEvents': 6, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCTCAE v.3'}, {'term': 'Chest/thoracic pain NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 41, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 40, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCTCAE v.3'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 25, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 41, 'numEvents': 17, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 31, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 40, 'numEvents': 55, 'numAffected': 13}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCTCAE v.3'}, {'term': 'Constitutional, other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 5, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 40, 'numEvents': 6, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCTCAE v.3'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 34, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 41, 'numEvents': 27, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 23, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 40, 'numEvents': 22, 'numAffected': 12}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCTCAE v.3'}, {'term': 'creatinine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 4, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 41, 'numEvents': 8, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 40, 'numEvents': 21, 'numAffected': 8}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCTCAE v.3'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 18, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 41, 'numEvents': 15, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 12, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 40, 'numEvents': 28, 'numAffected': 13}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCTCAE v.3'}, {'term': 'Diarrhea w/o prior colostomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 31, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 41, 'numEvents': 30, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 58, 'numAffected': 20}, {'groupId': 'EG003', 'numAtRisk': 40, 'numEvents': 32, 'numAffected': 14}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCTCAE v.3'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 41, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 6, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 40, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCTCAE v.3'}, {'term': 'Dry Eye Syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numEvents': 8, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 9, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 40, 'numEvents': 5, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCTCAE v.3'}, {'term': 'Dry Mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 40, 'numEvents': 11, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCTCAE v.3'}, {'term': 'Dry Skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 10, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 40, 'numEvents': 4, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCTCAE v.3'}, {'term': 'Dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 28, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 41, 'numEvents': 26, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 33, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 40, 'numEvents': 11, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCTCAE v.3'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 28, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 41, 'numEvents': 16, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 17, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 40, 'numEvents': 30, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Edema limb', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 15, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 41, 'numEvents': 29, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 17, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 40, 'numEvents': 11, 'numAffected': 5}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCTCAE v.3'}, {'term': 'Erythema multiforme', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 6, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 40, 'numEvents': 5, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCTCAE v.3'}, {'term': 'Extrapyramidal movement', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 6, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCTCAE v.3'}, {'term': 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'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCTCAE V3'}, {'term': 'Vagina, hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 40, 'numEvents': 4, 'numAffected': 2}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCTCAE V3'}, {'term': 'Vaginal discharge (non-infectious)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 41, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 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{'groupId': 'EG001', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 40, 'numEvents': 6, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCTCAE V3'}, {'term': 'Wound-non-infectious', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 40, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCTCAE V3'}, {'term': 'Cardiac-other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 41, 'numEvents': 7, 'numAffected': 3}, {'groupId': 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'sourceVocabulary': 'NCTCAE v.3'}, {'term': 'Lower GI bleed', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCTCAE v.3'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'The Completion Rate of 1 Year of Bevacizumab Therapy for All Four Cohorts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A- Bevacizumab Alone', 'description': 'Bevacizumab 15 mg/kg every 3 wks for 1 year'}, {'id': 'OG001', 'title': 'Group B-Bevacizumab+Cyclophosphamide+Methotrexate', 'description': 'Bevacizumab 15 mg/kg every 3 weeks for 1 year +Cyclophosphamide 50 mg orally daily for 6 months +methotrexate 2.5mg orally on day 1-2 each week for 6 months.'}, {'id': 'OG002', 'title': 'Group C-Bevacizumab + Capcitabine(18 Wks)', 'description': 'capecitabine 2000 mg/m2/day 14 days on/7 days off for 18 weeks, and bevacizumab 15 mg/kg every 3 weeks for 1 year'}, {'id': 'OG003', 'title': 'Group D-bevacizumab + Capecitibine (24wks)', 'description': 'capecitabine 2000 mg orally twice per day for 7 days on/7 days off for 24 weeks, and bevacizumab 15 mg/kg every 3 weeks for 1 year.'}], 'classes': [{'categories': [{'measurements': [{'value': '60', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '76', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 year', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Group A- Bevacizumab Alone', 'description': 'Bevacizumab 15 mg/kg every 3 wks for 1 year'}, {'id': 'FG001', 'title': 'Group B-Bevacizumab+Cyclophosphamide+Methotrexate', 'description': 'Bevacizumab 15 mg/kg every 3 weeks for 1 year +Cyclophosphamide 50 mg orally daily for 6 months +methotrexate 2.5mg orally on day 1-2 each week for 6 months.'}, {'id': 'FG002', 'title': 'Group C-Bevacizumab + Capcitabine(18 Wks)', 'description': 'capecitabine 2000 mg/m2/day 14 days on/7 days off for 18 weeks, and bevacizumab 15 mg/kg every 3 weeks for 1 year'}, {'id': 'FG003', 'title': 'Group D-bevacizumab + Capecitibine (24wks)', 'description': 'capecitabine 2000 mg orally twice per day for 7 days on/7 days off for 24 weeks, and bevacizumab 15 mg/kg every 3 weeks for 1 year.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '40'}, {'groupId': 'FG001', 'numSubjects': '41'}, {'groupId': 'FG002', 'numSubjects': '41'}, {'groupId': 'FG003', 'numSubjects': '40'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '26'}, {'groupId': 'FG002', 'numSubjects': '20'}, {'groupId': 'FG003', 'numSubjects': '31'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '15'}, {'groupId': 'FG002', 'numSubjects': '21'}, {'groupId': 'FG003', 'numSubjects': '9'}]}], 'dropWithdraws': [{'type': 'Progression of Disease', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '2'}]}, {'type': 'Toxicity', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '13'}, {'groupId': 'FG003', 'numSubjects': '5'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Treatment Delay', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Intercurrent Illness', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Patient Personal Reasons', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'This sequential cohort phase II study was performed in the outpatient setting at four institutions between 2005 and 2008.', 'preAssignmentDetails': 'A total of 164 participants were registered to enroll in the trial , but only 162 participants initiated treatment. So the evaluable population is 162 participants.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}, {'value': '40', 'groupId': 'BG003'}, {'value': '162', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Group A- Bevacizumab Alone', 'description': 'Bevacizumab 15 mg/kg every 3 wks for 1 year'}, {'id': 'BG001', 'title': 'Group B-Bevacizumab+Cyclophosphamide+Methotrexate', 'description': 'Bevacizumab 15 mg/kg every 3 weeks for 1 year +Cyclophosphamide 50 mg orally daily for 6 months +methotrexate 2.5mg orally on day 1-2 each week for 6 months.'}, {'id': 'BG002', 'title': 'Group C-Bevacizumab + Capcitabine(18 Wks)', 'description': 'capecitabine 2000 mg/m2/day 14 days on/7 days off for 18 weeks, and bevacizumab 15 mg/kg every 3 weeks for 1 year'}, {'id': 'BG003', 'title': 'Group D-bevacizumab + Capecitibine (24wks)', 'description': 'capecitabine 2000 mg orally twice per day for 7 days on/7 days off for 24 weeks, and bevacizumab 15 mg/kg every 3 weeks for 1 year.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '49.05', 'spread': '10.04', 'groupId': 'BG000'}, {'value': '48.83', 'spread': '10.34', 'groupId': 'BG001'}, {'value': '48.71', 'spread': '10.34', 'groupId': 'BG002'}, {'value': '49.55', 'spread': '9.09', 'groupId': 'BG003'}, {'value': '49.03', 'spread': '9.88', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}, {'value': '40', 'groupId': 'BG003'}, {'value': '162', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}, {'value': '40', 'groupId': 'BG003'}, {'value': '162', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 164}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-11', 'completionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-11-26', 'studyFirstSubmitDate': '2005-07-13', 'resultsFirstSubmitDate': '2013-08-08', 'studyFirstSubmitQcDate': '2005-07-19', 'lastUpdatePostDateStruct': {'date': '2013-12-24', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-08-08', 'studyFirstPostDateStruct': {'date': '2005-07-21', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-10-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Completion Rate of 1 Year of Bevacizumab Therapy for All Four Cohorts', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Bevacizumab', 'Metronomic Chemotherapy', 'Breast Cancer Stages II-III', 'Invasive breast cancer stages II-III'], 'conditions': ['Breast Cancer']}, 'referencesModule': {'references': [{'pmid': '39890560', 'type': 'DERIVED', 'citation': 'Trapani D, Jin Q, Miller KD, Rugo HS, Reeder-Hayes KE, Traina T, Abdou Y, Falkson C, Abramson V, Ligibel J, Chen W, Come S, Nohria A, Ryabin N, Tayob N, Tolaney SM, Burstein HJ, Mayer EL. Optimizing Postneoadjuvant Treatment of Residual Breast Cancer With Adjuvant Bevacizumab Alone, With Metronomic or Standard-Dose Chemotherapy: A Combined Analysis of DFCI 05-055 and DFCI 09-134/TBCRC 012/ABCDE Clinical Trials. Clin Breast Cancer. 2025 Jun;25(4):e419-e430.e5. doi: 10.1016/j.clbc.2024.12.018. Epub 2024 Dec 31.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this research study is to study the effects (good and bad) of bevacizumab alone, bevacizumab with low-dose continuous chemotherapy (called metronomic chemotherapy), or bevacizumab with capecitabine, on you and your cancer. The goals of the study will be to:\n\n* Examine the safety of these drugs\n* See how easy or difficult it is to be treated with them\n* Monitor for any signs of recurrent cancer\n* Look at blood markers that might indicate how the treatment is working', 'detailedDescription': 'This study is broken into 4 groups (A, B, C, and D). Enrollment closed to all groups in May 2008.\n\nThe first forty subjects (Group A) in this study were treated with Bevacizumab only, which is given through a vein over 1-2 hours every 3 weeks, for a total of approximately 12 months (17 cycles). Each cycle consists of 3 weeks.\n\nThe next forty subjects (Group B) were treated with Bevacizumab and metronomic CM chemotherapy. These subjects took cyclophosphamide (1 pill by mouth every day), methotrexate, (1 pill taken by mouth twice a day for the first two days of each week) and Bevacizumab (once every 3 weeks). The treatments with cyclophosphamide, methotrexate and Bevacizumab will continue for approximately 6 months (8 cycles). Then for the next 6 months, they received Bevacizumab treatments only. The total time on this study will be about 12 months (17 cycles).\n\nThe next forty subjects (Group C) were treated with Bevacizumab and Capecitabine chemotherapy. These subjects took Capecitabine pills twice a day for 14 days, then one week of rest, to complete a 21-day cycle. There will be a total of 6 cycles of Capecitabine, meaning 18 weeks of treatment with both Capecitabine and Bevacizumab. Then received Bevacizumab treatments only (11 cycles) to complete 12 months of therapy. Total duration of your treatment will be about 12 months or 17 cycles of therapy.\n\nThe last forty subjects (Group D) are being treated with Bevacizumab and Capecitabine chemotherapy on a different schedule. These subjects will take Capecitabine pills twice a day for 7 days, then one week of rest and repeat this for a total of 24 weeks (6 cycles). Each cycle will last for 4 weeks (28 days). There will be a total of 6 cycles of Capecitabine, meaning 24 weeks of treatment with both Capecitabine and Bevacizumab. Bevacizumab will be given every two weeks for a total of 24 weeks (6 cycles). Then they will receive Bevacizumab treatments only, every 3 weeks for additional 27 weeks (9 cycles) to complete 12 months of therapy. For the last 9 cycles of Bevacizumab therapy each cycle will consist of 3 weeks. Total duration of treatment will be about 12 months or 15 cycles of therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically or cytologically confirmed invasive breast cancer, preoperative stages II-III per AJCC 6th edition, based on baseline evaluation by clinical examination and/or breast imaging\n* Patients must have completed preoperative (neoadjuvant) chemotherapy with a standard chemotherapy regimen. No more chemotherapy should be planned.\n* Patients must have completed definitive resection of primary tumor with adequate excision of gross disease.\n* For patients receiving adjuvant radiation therapy, treatment must be completed prior to initiation of protocol therapy.\n* Patients must have the presence of significant residual invasive disease on pathologic review following their preoperative chemotherapy.\n* LVEF \\> institutional limits of normal after preoperative chemotherapy, as assessed by ECHO or nuclear medicine gated study, within 30 days prior to initiating protocol-based treatment.\n* ECOG performance status 0-1\n\nExclusion Criteria:\n\n* Inadequate organ function, as measured by laboratory assessment after preoperative chemotherapy and within 14 days of beginning protocol-based treatment\n* Patients with metastatic disease are ineligible.\n* Known HIV infection\n* Patients may not be pregnant, expect to become pregnant, plan to conceive a child while on study, or breastfeeding\n* Uncontrolled intercurrent illness\n* Non-healing wounds or major surgical procedures (such as breast surgery) other than that for venous access device or diagnostic study are not permitted within 28 day prior to enrollment\n* History of abdominal fistula, GI perforation, intra-abdominal abscess, or serious, non-healing wound, ulcer, or bone fracture within 6 months prior to initiating bevacizumab\n* Patients with any history of arterial thromboembolic events, including transient ischemic attack (TIA), cerebrovascular event (CVA), unstable angina, or myocardial infarction (MI) within the past 6 months. Patients with clinically significant peripheral arterial disease should also be excluded\n* History of bleeding diathesis or coagulopathy\n* History of grade 3 or 4 allergic reactions to compounds of similar chemical or biologic composition to cyclophosphamide (such as other alkylating agents) or methotrexate (such as other antimetabolites)\n* Prior history of malignancy treated without curative intent, excluding nonmelanomatous skin cancer\n* Patients with large or rapidly accumulating pleural or abdominal effusions\n* Current use of anticoagulants is allowed as long as patients have been on a stable dose for more than two weeks with stable INR\n* Chronic therapy with full dose aspirin (\\< 325 mg/day) or standard non-steroidal anti-inflammatory agents is allowed\n* Patients may not receive other investigational agents while on study'}, 'identificationModule': {'nctId': 'NCT00121134', 'briefTitle': 'Bevacizumab With or Without Cyclophosphamide and Methotrexate: A Pilot Study in Women With Operable Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Dana-Farber Cancer Institute'}, 'officialTitle': 'Anti-Angiogenesis Treatment After Preoperative Chemotherapy: A Pilot Study in Women With Operable Breast Cancer', 'orgStudyIdInfo': {'id': '05-055'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group A', 'description': 'Bevacizumab Alone', 'interventionNames': ['Drug: Bevacizumab']}, {'type': 'EXPERIMENTAL', 'label': 'Group B', 'description': 'Bevacizumab with cyclophosphamide and methotrexate', 'interventionNames': ['Drug: Bevacizumab', 'Drug: Cyclophosphamide', 'Drug: Methotrexate']}, {'type': 'EXPERIMENTAL', 'label': 'Group C', 'description': 'capecitabine, 14 days on/7 days off scheduling, and bevacizumab', 'interventionNames': ['Drug: Bevacizumab', 'Drug: Capecitabine']}, {'type': 'EXPERIMENTAL', 'label': 'Group D', 'description': 'capecitabine 7 days on/7 days off scheduling, and bevacizumab', 'interventionNames': ['Drug: Bevacizumab', 'Drug: Capecitabine']}], 'interventions': [{'name': 'Bevacizumab', 'type': 'DRUG', 'otherNames': ['Avastin'], 'description': 'Group A: Once every 3 weeks for 12 months Group B: Once every 3 weeks for 12 months', 'armGroupLabels': ['Group A', 'Group B', 'Group C', 'Group D']}, {'name': 'Cyclophosphamide', 'type': 'DRUG', 'otherNames': ['Cytoxan'], 'description': 'Once a day for 6 months', 'armGroupLabels': ['Group B']}, {'name': 'Methotrexate', 'type': 'DRUG', 'otherNames': ['amethopterin'], 'description': 'Twice daily for the first two days of every week for 6 months', 'armGroupLabels': ['Group B']}, {'name': 'Capecitabine', 'type': 'DRUG', 'otherNames': ['Xeloda'], 'description': 'Capecitabine: 2000 mg/m2 a day, on Days 1-14 of a 21 day cycle, for at total of 6 cycles (18 weeks)\n\nBevacizumab: 15 mg/kg IV day 1 every 3 weeks x 1 year (17 cycles)', 'armGroupLabels': ['Group C', 'Group D']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94122', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'University of California, San Francisco', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Indiana University Cancer Center', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Beth Israel Deaconess Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Dana-Farber Cancer Institute', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '27701', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'University of North Carolina', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}], 'overallOfficials': [{'name': 'Harold J Burstein, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dana-Farber Cancer Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Harold J. Burstein, MD, PhD', 'class': 'OTHER'}, 'collaborators': [{'name': 'Genentech, Inc.', 'class': 'INDUSTRY'}, {'name': 'Beth Israel Deaconess Medical Center', 'class': 'OTHER'}, {'name': 'Indiana University School of Medicine', 'class': 'OTHER'}, {'name': 'University of California, San Francisco', 'class': 'OTHER'}, {'name': 'University of North Carolina', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Medicine', 'investigatorFullName': 'Harold J. Burstein, MD, PhD', 'investigatorAffiliation': 'Dana-Farber Cancer Institute'}}}}