Ignite Creation Date:
2025-12-25 @ 3:20 AM
Ignite Modification Date:
2026-02-25 @ 4:38 PM
Study NCT ID:
NCT00866905
Status:
COMPLETED
Last Update Posted:
2021-11-22
First Post:
2009-03-19
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Ixabepilone and Cyclophosphamide as Neoadjuvant Therapy in HER-2 Negative 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': 'C430592', 'term': 'ixabepilone'}, {'id': 'D003520', 'term': 'Cyclophosphamide'}], 'ancestors': [{'id': 'D010752', 'term': 'Phosphoramide Mustards'}, {'id': 'D009588', 'term': 'Nitrogen Mustard Compounds'}, {'id': 'D009150', 'term': 'Mustard Compounds'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D063088', 'term': 'Phosphoramides'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'asksarah@scresearch.net', 'phone': '1-877-691-7274', 'title': 'John D. Hainsworth, MD', 'organization': 'Sarah Cannon Research Institute'}, 'certainAgreement': {'otherDetails': 'The sponsor can review/embargo results communications prior to public release for a period that is \\>60 days but ≤180 days from the date submitted to sponsor, who may require changes to the communication in order to remove specifically identified confidential information (other than study data) and/or delay the proposed publication to enable the sponsor to seek patent protection for inventions. The PI may not publish results until 18 mos. after the trial has been completed at all sites.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Ixabepilone/Cyclophosphamide', 'description': 'All patients who received a dose of study treatment', 'otherNumAtRisk': 168, 'otherNumAffected': 167, 'seriousNumAtRisk': 168, 'seriousNumAffected': 6}], 'otherEvents': [{'term': 'ABDOMINAL PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 29, 'numAffected': 14}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v 4.0'}, {'term': 'ALLERGIC REACTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v 4.0'}, {'term': 'ALLERGIC RHINITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 38, 'numAffected': 15}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v 4.0'}, {'term': 'ALOPECIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 390, 'numAffected': 100}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v 4.0'}, {'term': 'ANEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 430, 'numAffected': 118}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v 4.0'}, {'term': 'ANOREXIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 92, 'numAffected': 41}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v 4.0'}, {'term': 'ANXIETY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 79, 'numAffected': 25}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v 4.0'}, {'term': 'ARTHRALGIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 290, 'numAffected': 87}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v 4.0'}, {'term': 'ASTHENIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 30, 'numAffected': 17}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v 4.0'}, {'term': 'BACK PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 34, 'numAffected': 18}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v 4.0'}, {'term': 'BONE PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 26, 'numAffected': 16}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v 4.0'}, {'term': 'BREAST PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 34, 'numAffected': 15}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v 4.0'}, {'term': 'CHEST PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 16, 'numAffected': 9}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v 4.0'}, {'term': 'CONSTIPATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 175, 'numAffected': 60}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v 4.0'}, {'term': 'COUGH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 58, 'numAffected': 35}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v 4.0'}, {'term': 'DEHYDRATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 12, 'numAffected': 10}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v 4.0'}, {'term': 'DEPRESSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 40, 'numAffected': 17}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v 4.0'}, {'term': 'DIARRHEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 127, 'numAffected': 60}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v 4.0'}, {'term': 'DIZZINESS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 41, 'numAffected': 23}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v 4.0'}, {'term': 'DYSPEPSIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 88, 'numAffected': 32}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v 4.0'}, {'term': 'DYSPNEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 39, 'numAffected': 26}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v 4.0'}, {'term': 'EDEMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 32, 'numAffected': 14}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v 4.0'}, {'term': 'FATIGUE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 547, 'numAffected': 136}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v 4.0'}, {'term': 'FEBRILE NEUTROPENIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 15, 'numAffected': 12}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v 4.0'}, {'term': 'FEVER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 18, 'numAffected': 16}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v 4.0'}, {'term': 'HEADACHE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 95, 'numAffected': 38}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v 4.0'}, {'term': 'HOT FLASHES', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 79, 'numAffected': 30}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v 4.0'}, {'term': 'HYPERGLYCEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 31, 'numAffected': 14}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v 4.0'}, {'term': 'HYPERTENSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 28, 'numAffected': 13}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v 4.0'}, {'term': 'INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 18, 'numAffected': 13}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v 4.0'}, {'term': 'INSOMNIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 145, 'numAffected': 48}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v 4.0'}, {'term': 'LEUKOPENIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 457, 'numAffected': 128}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v 4.0'}, {'term': 'MUCOSITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 31, 'numAffected': 17}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v 4.0'}, {'term': 'MYALGIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 168, 'numAffected': 55}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v 4.0'}, {'term': 'NAIL CHANGES', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 27, 'numAffected': 12}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v 4.0'}, {'term': 'NAUSEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 297, 'numAffected': 102}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v 4.0'}, {'term': 'NEUTROPENIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 457, 'numAffected': 127}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v 4.0'}, {'term': 'PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 23, 'numAffected': 13}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v 4.0'}, {'term': 'PAIN IN EXTREMITY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 96, 'numAffected': 40}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v 4.0'}, {'term': 'PARESTHESIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 34, 'numAffected': 13}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v 4.0'}, {'term': 'PERIPHERAL NEUROPATHY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 399, 'numAffected': 117}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v 4.0'}, {'term': 'PRURITUS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 22, 'numAffected': 11}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v 4.0'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 37, 'numAffected': 21}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v 4.0'}, {'term': 'RASH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 53, 'numAffected': 29}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v 4.0'}, {'term': 'SORE THROAT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 11, 'numAffected': 10}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v 4.0'}, {'term': 'TASTE ALTERATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 122, 'numAffected': 35}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v 4.0'}, {'term': 'THROMBOCYTOPENIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 136, 'numAffected': 56}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v 4.0'}, {'term': 'UPPER RESPIRATORY INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 16, 'numAffected': 11}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v 4.0'}, {'term': 'VOMITING', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 54, 'numAffected': 32}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v 4.0'}, {'term': 'WEIGHT LOSS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 22, 'numAffected': 11}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v 4.0'}], 'seriousEvents': [{'term': 'DEPRESSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v 4.0'}, {'term': 'ENTERITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v 4.0'}, {'term': 'FEBRILE NEUTROPENIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v 4.0'}, {'term': 'PERIPHERAL NEUROPATHY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v 4.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Pathologic Complete Response Rate (pCR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '161', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ixabepilone/Cyclophosphamide', 'description': 'Systemic Therapy followed by surgery and possible radiation therapy'}], 'classes': [{'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 months', 'description': 'Pathologic complete response (pCR) rate will be determined by the pathologic evaluation of breast and lymph node samples collected at the time of surgery. pCR is defined as no residual disease in breast or lymph nodes in resected tissue samples.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'To be evaluable, patients had to undergo surgery after neoadjuvant therapy. Out of 168 patients, only 161 patients underwent surgery after neoadjuvant therapy and were included in this analysis.'}, {'type': 'SECONDARY', 'title': 'Absence of Grade-4 Non-hematologic Toxicity Excluding, Alopecia, Nausea, Vomiting and Bone Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '168', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ixabepilone/Cyclophosphamide', 'description': 'Systemic Therapy followed by surgery and possible radiation therapy'}], 'classes': [{'title': 'Fatigue', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Peripheral neuropathy', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Arthralgia/myalgia', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '3 months', 'description': 'Non hematologic treatment-related grade 4 toxicities measured according to CTCAE 3.0', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Overall Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '168', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ixabepilone/Cyclophosphamide', 'description': 'Systemic Therapy followed by surgery and possible radiation therapy\n\nIxabepilone: 40 mg/m2 IV infusion over 3 hours on day 1 of a 21 day cycle for 6 cycles\n\nCyclophosphamide: 600 mg/m2 IV infusion per institutional guidelines on day 1 of a 21 day cycle for 6 cycles'}], 'classes': [{'categories': [{'measurements': [{'value': '90', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '36 months', 'description': 'Overall survival (OS) determined as the time between day 1 cycle 1 to the date of death from any cause. The percentage of patients who were alive at 3 years, estimated by Kaplan Meier method as the probability of being event free at 3 years is reported here.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients who received a dose of study treatment.'}, {'type': 'SECONDARY', 'title': 'Disease Free Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '168', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ixabepilone/Cyclophosphamide', 'description': 'Ixabepilone: 40 mg/m2 via intraveous (IV) infusion over 3 hours\n\nCyclophosphamide: 600 mg/m2 via IV infusion per institutional guidelines'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Median and 95% confidence interval were not estimable by Kaplan-Meier method due to insufficient observed events.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '36 Months', 'description': 'Defined as the time between Day 1 Cycle 1, and date of first documented recurrence, initiation of additional chemotherapy, or death.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients who received a dose of study treatment.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Ixabepilone/Cyclophosphamide', 'description': 'Ixabepilone: 40 mg/m2 via intraveous (IV) infusion over 3 hours\n\nCyclophosphamide: 600 mg/m2 via IV infusion per institutional guidelines'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '168'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '135'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '33'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '168', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Arm/Group 1', 'description': 'All patients who received at least one dose of treatment.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '53', 'groupId': 'BG000', 'lowerLimit': '30', 'upperLimit': '79'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'Years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '168', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '168', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 168}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-11-18', 'studyFirstSubmitDate': '2009-03-19', 'resultsFirstSubmitDate': '2014-11-21', 'studyFirstSubmitQcDate': '2009-03-20', 'lastUpdatePostDateStruct': {'date': '2021-11-22', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2014-11-21', 'studyFirstPostDateStruct': {'date': '2009-03-23', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-11-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pathologic Complete Response Rate (pCR)', 'timeFrame': '6 months', 'description': 'Pathologic complete response (pCR) rate will be determined by the pathologic evaluation of breast and lymph node samples collected at the time of surgery. pCR is defined as no residual disease in breast or lymph nodes in resected tissue samples.'}], 'secondaryOutcomes': [{'measure': 'Absence of Grade-4 Non-hematologic Toxicity Excluding, Alopecia, Nausea, Vomiting and Bone Pain', 'timeFrame': '3 months', 'description': 'Non hematologic treatment-related grade 4 toxicities measured according to CTCAE 3.0'}, {'measure': 'Overall Survival', 'timeFrame': '36 months', 'description': 'Overall survival (OS) determined as the time between day 1 cycle 1 to the date of death from any cause. The percentage of patients who were alive at 3 years, estimated by Kaplan Meier method as the probability of being event free at 3 years is reported here.'}, {'measure': 'Disease Free Survival', 'timeFrame': '36 Months', 'description': 'Defined as the time between Day 1 Cycle 1, and date of first documented recurrence, initiation of additional chemotherapy, or death.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Breast Cancer', 'Ixabepilone', 'Ixempra', 'Cyclophosphamide', 'Cytoxan', 'Neoadjuvant Therapy'], 'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'We propose to evaluate ixabepilone in combination with cyclophosphamide for the neoadjuvant treatment of locally advanced breast cancer. In this regimen, ixabepilone is substituted for docetaxel, since preclinical and clinical\n\nstudies suggest that ixabepilone is more active than either docetaxel or paclitaxel. The combination of ixabepilone and cyclophosphamide could further improve the efficacy of non-anthracycline neoadjuvant therapy.', 'detailedDescription': "In this study, patients with early stage, HER2-negative breast cancer will receive neoadjuvant treatment with ixabepilone and cyclophosphamide given every three weeks for a total of six cycles. Following surgery patients with hormone receptor-positive tumors will receive anti-estrogen treatment. Patients may receive local regional radiation therapy after surgery per institutional guidelines at the investigator's discretion. Baseline tumor tissue and tumor tissue removed at the time of surgery will be tested by Oncotype Detailed Description (DX) assay to determine whether it is predictive of response to this neoadjuvant treatment regimen. This study will be one of the first investigations of the combination of ixabepilone and cyclophosphamide as neoadjuvant treatment for HER2-negative breast cancer. It will examine this treatment regimen for potential advantages gained from substitution of ixabepilone for a taxane and use of non-anthracycline agents."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Female patients, age ≥18 years.\n2. Histologically confirmed invasive adenocarcinoma of the breast.\n3. Primary palpable disease confined to a breast and axilla on\n\n physical examination. For patients without clinically suspicious\n\n axillary adenopathy, the primary tumor must be larger than 2 cm\n\n in diameter by physical exam or imaging studies (clinical T2-T3,\n\n N0-N1, M0). For patients with clinically suspicious axillary\n\n adenopathy, the primary breast tumor can be any size (clinical\n\n T1-3, N1-2, M0). (T1N0M0 lesions are excluded.)\n4. Patients without clearly defined palpable breast mass or axillary\n\n lymph nodes but radiographically measurable tumor masses are\n\n acceptable. Accepted procedures for measuring breast disease\n\n are mammography, MRI, and breast ultrasound. This will need to\n\n be re-evaluated after 3 cycles and prior to surgery.\n5. Eastern Cooperative Oncology Group performance status (ECOG\n\n PS) 0-2.\n6. No metastatic disease, as documented by complete staging workup\n\n * 6 weeks prior to initiation of study treatment.\n7. No previous treatment for breast cancer.\n8. HER2-negative tumor status. HER2-negative is defined as:\n\n * Immunohistochemical (IHC) 0, IHC 1+ OR\n * IHC 2+ or IHC 3+ must be confirmed as FISH (fluorescence in situ\n\n hybridization) negative (defined by ratio \\<2.2).\n9. Adequate hematologic function with:\n\n * Absolute neutrophil count (ANC) \\>1500/μL.\n * Platelets ≥100,000/μL.\n * Hemoglobin ≥10 g/dL.\n10. Adequate hepatic function with:\n\n * Serum bilirubin ≤ the institutional upper limit of normal (ULN).\n * Aspartate aminotransferase (AST) ≤2.5 x institutional ULN.\n * Alanine aminotransferase (ALT) ≤2.5 x institutional ULN.\n11. Adequate renal function with serum creatinine ≤1.5 x ULN.\n12. Estrogen and progesterone receptor status in the primary tumor\n\n known or pending at the time of study registration.\n13. Knowledge of the investigational nature of the study and ability to\n\n provide consent for study participation.\n14. For patients who had, or will have sentinel lymph node and/or\n\n axillary dissection prior to initiation of study treatment, completion\n\n at least 4 weeks prior to starting study treatment and well-healed\n\n wound\n15. Bilateral, synchronous breast cancer is allowed if one primary\n\n tumor meets the inclusion criteria.\n16. Sufficient archived breast tumor specimen available at baseline\n\nfor the Oncotype DX assay.\n\n\\-\n\nExclusion Criteria:\n\n1. Inflammatory breast cancer.\n2. Peripheral neuropathy (motor or sensory) ≥ grade 1 by the\n\n Common Terminology Criteria for Adverse Events version 3.0\n\n (CTCAE v 3.0).\n3. Prior radiation that included ≥30% of major bone marrow containing\n\n areas (pelvis, lumbar, spine).\n4. Chronic use of cytochrome P450 (CYP) 3A4 inhibitors and use of\n\n the following strong CYP3A4 inhibitors: ketoconazole,\n\n itraconazole, clarithromycin, atazanavir, nefazodone, saquinavir,\n\n telithromycin, ritonavir, amprenavir, indinavir, nelfinavir,\n\n delavirdine, and voriconazole. Use of these agents should be\n\n discontinued at least 72 hours prior to initiation of study treatment.\n5. Chemotherapy within 5 years of starting study treatment except\n\n for low doses of agents used for anti-inflammatory indications\n\n such as rheumatoid arthritis, psoriasis, and connective tissue\n\n disorders. Although such doses and schedules cannot result in\n\n myelosuppression, patients must discontinue this therapy while\n\n they are receiving study treatment.\n6. Known or suspected hypersensitivity to Cremophor®EL\n\n (polyoxyethylated castor oil) or a drug formulated in\n\n Cremophor®EL such as paclitaxel, or any other agent given in the\n\n course of this study.\n7. Pregnancy or breast-feeding. A negative serum pregnancy test\n\n within 7 days prior to first study treatment (Day 1, Cycle 1) for all\n\n women of childbearing potential is required. Patients of\n\n childbearing potential must agree to use a birth control method\n\n that is approved by their study physician while receiving study\n\n treatment and for 3 weeks after their last dose of study treatment.\n\n Patients must agree to not breast-feed while receiving study\n\n treatment.\n8. Concurrent treatment with an ovarian hormonal replacement\n\n therapy or with hormonal agents such as raloxifene, tamoxifen or\n\n other selective estrogen receptor modulator (SERM). Patients\n\n must have discontinued use of such agents prior to beginning\n\n study treatment.\n9. History of malignancy treated with curative intent within the\n\n previous 5 years with the exception of skin cancer, cervical\n\n carcinoma in situ, or follicular thyroid cancer. Patients with\n\n previous invasive cancers (including breast cancer) are eligible if\n\n the treatment was completed more than 5 years prior to initiating\n\n current study treatment, and there is no evidence of recurrent\n\n disease.\n10. Uncontrolled intercurrent illness including (but not limited to)\n\n ongoing or active infection.\n11. Chronic treatment with corticosteroid unless treatment was begun\n\n \\>6 months prior to study treatment and is at a low dose (≤20 mg\n\n methylprednisolone or equivalent).\n12. Use of any investigational agent within 30 days of administration\n\n of the first dose of study drug.\n13. Requirement for radiation therapy concurrent with neoadjuvant\n\n study chemotherapy.\n14. Concurrent treatment with any anti-cancer therapy other than\n\n those agents used in this study.\n15. Inability or unwillingness to comply with study procedures\n\n including follow-up visits.\n16. Mental condition or psychiatric disorder that would prevent patient\n\n comprehension of the nature, scope, and possible consequences\n\n of the study or that would limit compliance with study\n\n requirements.\n17. Any other disease(s), metabolic dysfunction, or findings from a\n\nphysical examination or clinical laboratory test result that would\n\ncause reasonable suspicion of a disease or condition that\n\ncontraindicates the use of study drugs, that may affect the\n\ninterpretation of the results, or that renders the patient at high risk\n\nfrom treatment complications\n\n\\-'}, 'identificationModule': {'nctId': 'NCT00866905', 'briefTitle': 'Ixabepilone and Cyclophosphamide as Neoadjuvant Therapy in HER-2 Negative Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'SCRI Development Innovations, LLC'}, 'officialTitle': 'Phase II Study of Ixabepilone and Cyclophosphamide as Neoadjuvant Therapy in HER2-Negative Breast Cancer', 'orgStudyIdInfo': {'id': 'SCRI BRE 133'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ixabepilone/Cyclophosphamide', 'description': 'Systemic Therapy followed by surgery and possible radiation therapy', 'interventionNames': ['Drug: Ixabepilone', 'Drug: Cyclophosphamide']}], 'interventions': [{'name': 'Ixabepilone', 'type': 'DRUG', 'otherNames': ['Systemic therapy', 'Ixempra'], 'description': '40 mg/m2 IV infusion over 3 hours on day 1 of a 21 day cycle for 6 cycles', 'armGroupLabels': ['Ixabepilone/Cyclophosphamide']}, {'name': 'Cyclophosphamide', 'type': 'DRUG', 'otherNames': ['Systemic therapy', 'Cytoxan'], 'description': '600 mg/m2 IV infusion per institutional guidelines on day 1 of a 21 day cycle for 6 cycles', 'armGroupLabels': ['Ixabepilone/Cyclophosphamide']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33180', 'city': 'Aventura', 'state': 'Florida', 'country': 'United States', 'facility': 'Aventura Medical Center', 'geoPoint': {'lat': 25.95648, 'lon': -80.13921}}, {'zip': '33901', 'city': 'Fort Myers', 'state': 'Florida', 'country': 'United States', 'facility': 'Florida Cancer Specialists', 'geoPoint': {'lat': 26.62168, 'lon': -81.84059}}, {'zip': '33805', 'city': 'Lakeland', 'state': 'Florida', 'country': 'United States', 'facility': 'Watson Clinic Center for Cancer Care and Research', 'geoPoint': {'lat': 28.03947, 'lon': -81.9498}}, {'zip': '30901', 'city': 'Augusta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Medical Oncology Associates of Augusta', 'geoPoint': {'lat': 33.47097, 'lon': -81.97484}}, {'zip': '30501', 'city': 'Gainesville', 'state': 'Georgia', 'country': 'United States', 'facility': 'Northeast Georgia Medical Center', 'geoPoint': {'lat': 34.29788, 'lon': -83.82407}}, {'zip': '47802', 'city': 'Terre Haute', 'state': 'Indiana', 'country': 'United States', 'facility': 'Providence Medical Group', 'geoPoint': {'lat': 39.4667, 'lon': -87.41391}}, {'zip': '04101', 'city': 'Portland', 'state': 'Maine', 'country': 'United States', 'facility': 'Mercy Hospital', 'geoPoint': {'lat': 43.65737, 'lon': -70.2589}}, {'zip': '20817', 'city': 'Bethesda', 'state': 'Maryland', 'country': 'United States', 'facility': 'Center for Cancer and Blood Disorders', 'geoPoint': {'lat': 38.98067, 'lon': -77.10026}}, {'zip': '20817', 'city': 'Bethesda', 'state': 'Maryland', 'country': 'United States', 'facility': 'National Capital Clinical Research Consortium', 'geoPoint': {'lat': 38.98067, 'lon': -77.10026}}, {'zip': '63017', 'city': 'Chesterfield', 'state': 'Missouri', 'country': 'United States', 'facility': 'St. Louis Cancer Care', 'geoPoint': {'lat': 38.66311, 'lon': -90.57707}}, {'zip': '68114', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Methodist Cancer Center', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'zip': '07960', 'city': 'Morristown', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Hematology Oncology Associates of Northern NJ', 'geoPoint': {'lat': 40.79677, 'lon': -74.48154}}, {'zip': '45242', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Oncology Hematology Care', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '73505', 'city': 'Lawton', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Cancer Centers of Southwest Oklahoma', 'geoPoint': {'lat': 34.60869, 'lon': -98.39033}}, {'zip': '29210', 'city': 'Columbia', 'state': 'South Carolina', 'country': 'United States', 'facility': 'South Carolina Oncology Associates, PA', 'geoPoint': {'lat': 34.00071, 'lon': -81.03481}}, {'zip': '37404', 'city': 'Chattanooga', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Chattanooga Oncology Hematology Associates', 'geoPoint': {'lat': 35.04563, 'lon': -85.30968}}, {'zip': '38017', 'city': 'Collierville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Family Cancer Center', 'geoPoint': {'lat': 35.04204, 'lon': -89.66453}}, {'zip': '37203', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Tennessee Oncology', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '78258', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'South Texas Oncology and Hematology', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '23235', 'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'facility': 'Virginia Cancer Institute', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}], 'overallOfficials': [{'name': 'Denise A Yardley, M.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'SCRI Development Innovations, LLC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'SCRI Development Innovations, LLC', 'class': 'OTHER'}, 'collaborators': [{'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}