Ignite Creation Date:
2025-12-25 @ 4:17 AM
Ignite Modification Date:
2025-12-26 @ 3:18 AM
Study NCT ID:
NCT01593020
Status:
COMPLETED
Last Update Posted:
2021-09-22
First Post:
2012-05-03
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Neoadjuvant Study of Sequential Eribulin Followed by FAC Compared to Sequential Paclitaxel Followed by FEC in Early Stage Breast Cancer Not Overexpressing HER-2
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': 'D017239', 'term': 'Paclitaxel'}, {'id': 'C490954', 'term': 'eribulin'}, {'id': 'D005472', 'term': 'Fluorouracil'}, {'id': 'D015251', 'term': 'Epirubicin'}, {'id': 'D003520', 'term': 'Cyclophosphamide'}, {'id': 'D004317', 'term': 'Doxorubicin'}], 'ancestors': [{'id': 'D043823', 'term': 'Taxoids'}, {'id': 'D043822', 'term': 'Cyclodecanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D014498', 'term': 'Uracil'}, {'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic 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': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D000617', 'term': 'Aminoglycosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D010752', 'term': 'Phosphoramide Mustards'}, {'id': 'D009588', 'term': 'Nitrogen Mustard Compounds'}, {'id': 'D009150', 'term': 'Mustard Compounds'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D063088', 'term': 'Phosphoramides'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'vvalero@mdanderson.org', 'phone': '(713) 563-0751', 'title': 'Dr. Valero Vicente, Professor, Breast Medical Oncology', 'organization': 'UT MD Anderson Cancer Center'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'The duration of chemotherapy treatment per subject will be approximately 6 months, corresponding to 4 cycles of eribulin followed by 4 cycles of FAC/FEC-regimen or 12 cycles of weekly paclitaxel followed by 4 cycles of FAC/FEC-regimen. Post chemotherapy, patient will undergo definitive breast surgery 4 -6 weeks from last dose of FAC/FEC-regimen. 2 weeks Follow up post surgery', 'description': 'Only \\>/= grade 3 serious adverse events are reported', 'eventGroups': [{'id': 'EG000', 'title': 'Paclitaxel Weekly for 12 Doses Followed by FAC/FEC', 'description': 'Patients will receive Paclitaxel 80 mg/m2 IVPB over 1 hour weekly for 12 doses followed by FAC/FEC.', 'otherNumAtRisk': 28, 'deathsNumAtRisk': 28, 'otherNumAffected': 0, 'seriousNumAtRisk': 28, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG001', 'title': 'Eribulin on Days 1 and 8 Every 3 Weeks for 4 Cycles (21 Day Cycle) Followed by FAC/FEC', 'description': 'Patients will receive eribulin 1.4 mg/m2 IV infusion or per institutional guidelines over 2-5 minutes on days 1 and 8 every 3 weeks for 4 cycles (21 day cycle) followed by FAC/FEC.', 'otherNumAtRisk': 23, 'deathsNumAtRisk': 23, 'otherNumAffected': 0, 'seriousNumAtRisk': 23, 'deathsNumAffected': 1, 'seriousNumAffected': 9}], 'seriousEvents': [{'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Paresthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Nasal congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'White blood cell decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Left ventricular systolic dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Pathologic Complete Response (pCR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Paclitaxel Weekly for 12 Doses Followed by FAC/FEC', 'description': 'Patients will receive Paclitaxel 80 mg/m2 IVPB over 1 hour weekly for 12 doses followed by FAC/FEC.'}, {'id': 'OG001', 'title': 'Eribulin on Days 1 and 8 Every 3 Weeks for 4 Cycles (21 Day Cycle) Followed by FAC/FEC', 'description': 'Patients will receive eribulin 1.4 mg/m2 IV infusion or per institutional guidelines over 2-5 minutes on days 1 and 8 every 3 weeks for 4 cycles (21 day cycle) followed by FAC/FEC.'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '4 -6 weeks from last dose of FAC/FEC-regimen.', 'description': 'Pathologic complete response (pCR) defined as complete absence of any viable invasive cancer cells in the resected breast and lymph nodes. Participants undergo definitive breast surgery 4 -6 weeks from last dose of FAC/FEC-regimen. Tumors removed by either lumpectomy with axillary dissection (i.e. breast conservation surgery) or modified radical mastectomy (i.e. mastectomy with axillary clearance). Surgical specimens (breast and axillary lymph node tissue) evaluated for pathological complete response.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': '5 Year Event Free Survival (EFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Paclitaxel Weekly for 12 Doses Followed by FAC/FEC', 'description': 'Patients will receive Paclitaxel 80 mg/m2 IVPB over 1 hour weekly for 12 doses followed by FAC/FEC.'}, {'id': 'OG001', 'title': 'Eribulin on Days 1 and 8 Every 3 Weeks for 4 Cycles (21 Day Cycle) Followed by FAC/FEC', 'description': 'Patients will receive eribulin 1.4 mg/m2 IV infusion or per institutional guidelines over 2-5 minutes on days 1 and 8 every 3 weeks for 4 cycles (21 day cycle) followed by FAC/FEC.'}], 'classes': [{'categories': [{'measurements': [{'value': '81.8', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'from start of treatment, up to 5 years', 'description': 'Event free survival (EFS) the length of time after primary treatment for a cancer ends that the patient remains free of certain complications or events that the treatment was intended to prevent or delay.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Overall Survival (OS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Paclitaxel Weekly for 12 Doses Followed by FAC/FEC', 'description': 'Patients will receive Paclitaxel 80 mg/m2 IVPB over 1 hour weekly for 12 doses followed by FAC/FEC.'}, {'id': 'OG001', 'title': 'Eribulin on Days 1 and 8 Every 3 Weeks for 4 Cycles (21 Day Cycle) Followed by FAC/FEC', 'description': 'Patients will receive eribulin 1.4 mg/m2 IV infusion or per institutional guidelines over 2-5 minutes on days 1 and 8 every 3 weeks for 4 cycles (21 day cycle) followed by FAC/FEC.'}], 'classes': [{'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '84.4', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'from start of treatment, up to 5 years', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Paclitaxel Weekly for 12 Doses Followed by FAC/FEC', 'description': 'Patients will receive Paclitaxel 80 mg/m2 IVPB over 1 hour weekly for 12 doses followed by FAC/FEC.'}, {'id': 'FG001', 'title': 'Eribulin on Days 1 and 8 Every 3 Weeks for 4 Cycles (21 Day Cycle) Followed by FAC/FEC', 'description': 'Patients will receive eribulin 1.4 mg/m2 IV infusion or per institutional guidelines over 2-5 minutes on days 1 and 8 every 3 weeks for 4 cycles (21 day cycle) followed by FAC/FEC.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '28'}, {'groupId': 'FG001', 'numSubjects': '23'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '21'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Ineligible', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Patients were recruited from August 2012 to July 2014. This study was conducted at the University of Texas MD Anderson Cancer Center main campus and the Regional Care Centers (RCC).', 'preAssignmentDetails': '54 patients were accrued. 28 patients were randomized to Paclitaxel and 26 patients to Eribulin group. 2 patients from eribulin were found ineligible and never received treatment and 1 patient withdrew due to physician decision.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Paclitaxel Weekly for 12 Doses Followed by FAC/FEC', 'description': 'Patients will receive Paclitaxel 80 mg/m2 IVPB over 1 hour weekly for 12 doses followed by FAC/FEC.'}, {'id': 'BG001', 'title': 'Eribulin on Days 1 and 8 Every 3 Weeks for 4 Cycles (21 Day Cycle) Followed by FAC/FEC', 'description': 'Patients will receive eribulin 1.4 mg/m2 IV infusion or per institutional guidelines over 2-5 minutes on days 1 and 8 every 3 weeks for 4 cycles (21 day cycle) followed by FAC/FEC.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2014-10-22', 'size': 1132321, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-08-24T19:43', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 54}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-08-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2020-11-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-08-26', 'studyFirstSubmitDate': '2012-05-03', 'resultsFirstSubmitDate': '2021-08-26', 'studyFirstSubmitQcDate': '2012-05-04', 'lastUpdatePostDateStruct': {'date': '2021-09-22', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-08-26', 'studyFirstPostDateStruct': {'date': '2012-05-07', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-09-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-11-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pathologic Complete Response (pCR)', 'timeFrame': '4 -6 weeks from last dose of FAC/FEC-regimen.', 'description': 'Pathologic complete response (pCR) defined as complete absence of any viable invasive cancer cells in the resected breast and lymph nodes. Participants undergo definitive breast surgery 4 -6 weeks from last dose of FAC/FEC-regimen. Tumors removed by either lumpectomy with axillary dissection (i.e. breast conservation surgery) or modified radical mastectomy (i.e. mastectomy with axillary clearance). Surgical specimens (breast and axillary lymph node tissue) evaluated for pathological complete response.'}], 'secondaryOutcomes': [{'measure': '5 Year Event Free Survival (EFS)', 'timeFrame': 'from start of treatment, up to 5 years', 'description': 'Event free survival (EFS) the length of time after primary treatment for a cancer ends that the patient remains free of certain complications or events that the treatment was intended to prevent or delay.'}, {'measure': 'Overall Survival (OS)', 'timeFrame': 'from start of treatment, up to 5 years'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Breast cancer', 'Early Stage Breast Cancer Not Overexpressing HER-2', 'Primary invasive adenocarcinoma of the breast', 'Paclitaxel', 'Taxol', 'Eribulin', 'E7389', '5-Fluorouracil', '5-FU', 'Adrucil', 'Efudex', 'Epirubicin', 'Ellence', 'Cyclophosphamide', 'Cytoxan', 'Neosar', 'Doxorubicin', 'Doxorubicin hydrochloride', 'Adriamycin PFS', 'Adriamycin RDF', 'Adriamycin', 'Rubex'], 'conditions': ['Breast Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.mdanderson.org', 'label': 'University of Texas MD Anderson Cancer Center Website'}]}, 'descriptionModule': {'briefSummary': 'The goal of this clinical research study is to learn if and how well eribulin, given in combination with standard chemotherapy, can treat early-stage breast cancer compared to paclitaxel given in combination with standard chemotherapy. In this study, the standard chemotherapy being given is either 5-fluorouracil, epirubicin, and cyclophosphamide (called FEC) or 5-fluorouracil, doxorubicin, and cyclophosphamide (called FAC).\n\nEribulin is a changed version of the structure of a natural substance from a sea sponge. It is designed to block cells from dividing, which may cause cancer cells to die.\n\nPaclitaxel is designed to block cancer cells from dividing, which may cause them to die.\n\n5-fluorouracil is designed to block cancer cells from growing and dividing, which may slow or stop their growth and spread throughout the body. This may cause the cancer cells to die.\n\nEpirubicin is designed to block the way cancer cells grow and divide, which may slow or stop their growth and spread throughout the body. This may cause the cancer cells to die.\n\nDoxorubicin is designed to stop the growth of cancer cells, which may cause the cells to die.\n\nCyclophosphamide is designed to interfere with the multiplication of cancer cells, which may slow or stop their growth and/or keep them from spreading throughout the body. This may cause the cancer cells to die.', 'detailedDescription': 'Study Groups If you are found to be eligible to take part in this study, you will be randomly assigned (as in the flip of a coin) to 1 of 2 groups. You will have an equal chance of being assigned to either group.\n\nIf you are in Group 1, you will receive paclitaxel for 4 cycles. You also will be treated with FAC or FEC for 4 cycles. Your treating doctor will decide whether you will receive FEC or FAC.\n\nIf you are in Group 2, you will receive eribulin for 4 cycles. You will also be treated with FAC or FEC for 4 cycles. Your treating doctor will decide whether you will receive FEC or FAC.\n\nEach cycle is 21 days.\n\nStudy Drug Administration for Group 1 You will receive paclitaxel by vein over 1 hour on Days 1, 8, and 15 of each 21-day study cycle.\n\nBefore the infusion, you will be given drugs by vein, to help decrease the risk of an allergic reaction.\n\nIf you have severe side effects, future treatments may be delayed, the dose may be decreased, or you may be taken off study.\n\nOnce you have received 4 cycles of paclitaxel, you will receive either FEC or FAC chemotherapy for 4 cycles. Your treating doctor will decide whether you will receive FEC or FAC.\n\nStudy Drug Administration for Group 2 You will receive eribulin by vein over 2-5 minutes on Days 1 and 8 of each 21-day study cycle.\n\nOnce you have received 4 cycles of eribulin, you will receive FEC or FAC chemotherapy for 4 cycles. Your treating doctor will decide whether you will receive FEC or FAC.\n\nFEC or FAC Treatment After you have received 4 cycles of either paclitaxel or eribulin, you will receive FEC or FAC.\n\nIf you are given FEC chemotherapy, you will receive 5-Fluorouracil by vein over 15 minutes, epirubicin by vein over 30 minutes, and cyclophosphamide by vein over 30-60 minutes on Day 1 of every 21-day cycle.\n\nIf you are given FAC chemotherapy, you will receive 5-Fluorouracil by vein over 15 minutes, doxorubicin by vein over 15 minutes, and cyclophosphamide by vein over 30-60 minutes on Day 1 of 21-day cycle.\n\nBefore FEC or FAC chemotherapy, you will be given drugs by vein to help decrease the risk of allergic reaction. These drugs will include dexamethasone and zofran.\n\nStudy Visits During Paclitaxel or Eribulin On Day 1 of each cycle: If you have had these tests within 10 days before Day 1 of Cycle 1, they may not need to be repeated.\n\nYou will have a physical exam, including a measurement of your weight and vital signs.\n\nYou will be asked about any side effects you may be having and any drugs you may be taking.\n\nYour performance status will be recorded. Blood (about 1-2 teaspoons) will be drawn for routine tests.\n\nOn Days 8 and 15 of Cycle 1-4, blood (about 1 teaspoon) will be drawn for routine tests.\n\nAt Week 12, you will have a core biopsy.\n\nAt the end of Cycle 4:\n\nYou will have an ultrasound of the breast to check the status of the disease. You will have an ECHO or MUGA scan. You will have a core biopsy and fine needle aspiration of the tumor. A small needle will be inserted into the tumor at the safest and easiest location to withdraw cancer cells. This will be used to learn which tumor markers may predict who may best respond to therapy.\n\nStudy Visits During FEC or FAC Chemotherapy\n\nOn Day 1 of every third week:\n\nYou will have a physical exam, including a measurement of your weight and vital signs.\n\nYou will be asked about any side effects you may be having and any drugs you may be taking.\n\nYour performance status will be recorded. Blood (about 1-2 teaspoons) will be drawn for routine tests.\n\nAfter you have finished FEC or FAC treatment, you may have surgery. At the end of the chemotherapy treatment, you will be referred to the breast surgeon to discuss surgery. There is an small possibility (less than 3%) that tumor has gotten worse during treatment, and additional chemotherapy may be necessary.\n\nLength of Study You may continue taking the study drug for as long as the doctor thinks it is in your best interest. You will no longer be able to take the study drug if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions.\n\nThis is an investigational study. Paclitaxel, doxorubicin, epirubicin, and cyclophosphamide are FDA approved and commercially available for the treatment of breast cancer. Eribulin is FDA approved and commercially available to treat metastatic breast cancer in patients who have received at least 2 chemotherapy regimens for the treatment of metastatic disease. The use of eribulin with the FEC/FAC regimens is investigational for neoadjuvant treatment.\n\nEribulin will be provided at no cost to you while you are on this study. You and/or your insurance provider will be responsible for the cost of paclitaxel, doxorubicin, epirubicin, and cyclophosphamide.\n\nUp to 162 patients will take part in this study. All will be enrolled at MD Anderson.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Signed written informed consent\n2. Histologically confirmed primary invasive adenocarcinoma of the breast.\n3. Clinical stage breast cancer T2-3, N0-3, M0\n4. Negative HER-2/neu expression as determined by local hospital laboratory using Fluorescence In Situ Hybridization (FISH), or is less or equal to 1+ using Immunohistochemistry (IHC).\n5. No prior treatment for primary invasive adenocarcinoma of the breast such as irradiation, chemotherapy, hormonal therapy, immunotherapy, investigational therapy or surgery. Subjects receiving hormone replacement treatment (HRT) are eligible if this therapy is discontinued at least 2 weeks before starting study treatment. Treatment for DCIS is allowed, such as surgery, hormonal therapy and radiotherapy.\n6. Karnofsky performance status (KPS) of 80 - 100\n7. The ability and willingness to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.\n8. Baseline MUGA or echocardiogram scans with LVEF of \\> 50%.\n9. Normal PTT and either INR or PT \\< 1.5 x ULN.\n10. Men or women 18 years of age or older.\n11. Women of childbearing potential (WOCBP) must agree to use a medically acceptable method of contraception to avoid pregnancy throughout the study and for up to 8 weeks after the last dose of study drugs.\n12. Willingness to have core biopsies and/or FNA performed before the start of study treatment and at the end of 12 week on treatment.\n\nExclusion Criteria:\n\n1. Women who are pregnant (including positive pregnancy test at enrollment or prior to study drug administration) or breast-feeding.\n2. Disease free of prior malignancy for \\< 5 years with the exception of DCIS, curatively treated basal carcinoma of the skin, local skin squamous cell carcinoma, or carcinoma in situ of the cervix.\n3. Absolute neutrophils count (ANC) \\< 1500/mm\\^3\n4. Total bilirubin \\> 1.5 times the upper limit of normal (ULN)\n5. AST or ALT \\> 2.5 times the upper limit of normal (ULN)\n6. Platelets \\< 100,000/mm\\^3.\n7. Serum creatinine \\> 1.5 x ULN or creatinine clearance \\< 60 mL/min (measured or calculated by Cockcroft-Galt method)\n8. Evidence of metastatic breast cancer following a standard tumor staging work-up\n9. Evidence of inflammatory breast cancer.\n10. Evidence of any grade 2 sensory or motor neuropathy.\n11. Known human immunodeficiency viral (HIV) infection\n12. Serious intercurrent infections or non-malignant medical illness that are uncontrolled or the control of which may be jeopardized by this therapy.\n13. Psychiatric disorders or other conditions rendering the subject incapable of complying with the requirements of the protocols.'}, 'identificationModule': {'nctId': 'NCT01593020', 'briefTitle': 'Neoadjuvant Study of Sequential Eribulin Followed by FAC Compared to Sequential Paclitaxel Followed by FEC in Early Stage Breast Cancer Not Overexpressing HER-2', 'organization': {'class': 'OTHER', 'fullName': 'M.D. Anderson Cancer Center'}, 'officialTitle': 'A Randomized Phase II Neoadjuvant Study of Sequential Eribulin Followed by FAC/FEC-regimen Compared to Sequential Paclitaxel Followed by FAC/FEC-Regimen in Women With Early Stage Breast Cancer Not Overexpressing HER-2', 'orgStudyIdInfo': {'id': '2012-0167'}, 'secondaryIdInfos': [{'id': 'NCI-2012-00851', 'type': 'REGISTRY', 'domain': 'NCI CTRP'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Paclitaxel + FEC or FAC Group', 'description': 'ARM 1: Participants receive Paclitaxel 80 mg/m2 by vein over 1 hour weekly for 12 doses of a 21 day cycle.\n\nParticipants on both arms receive FEC or FAC for 4 cycles (21 day cycle) at the preference of the treating physicians.', 'interventionNames': ['Drug: Paclitaxel', 'Drug: 5-Fluorouracil', 'Drug: Epirubicin', 'Drug: Cyclophosphamide', 'Drug: Doxorubicin']}, {'type': 'EXPERIMENTAL', 'label': 'Eribulin + FEC or FAC Group', 'description': 'ARM 2: Participants receive Eribulin 1.4 mg/m2 by vein over 2-5 minutes on days 1 and 8 every 3 weeks for 4 cycles (21 day cycle).\n\nParticipants on both arms receive FEC or FAC for 4 cycles (21 day cycle) at the preference of the treating physicians.', 'interventionNames': ['Drug: Eribulin', 'Drug: 5-Fluorouracil', 'Drug: Epirubicin', 'Drug: Cyclophosphamide', 'Drug: Doxorubicin']}], 'interventions': [{'name': 'Paclitaxel', 'type': 'DRUG', 'otherNames': ['Taxol'], 'description': '80 mg/m2 by vein over 1 hour on Days 1, 8, and 15 of each 21-day cycle.', 'armGroupLabels': ['Paclitaxel + FEC or FAC Group']}, {'name': 'Eribulin', 'type': 'DRUG', 'otherNames': ['E7389'], 'description': '1.4 mg/m2 by vein over 2-5 minutes on Days 1 and 8 of each 21-day study cycle.', 'armGroupLabels': ['Eribulin + FEC or FAC Group']}, {'name': '5-Fluorouracil', 'type': 'DRUG', 'otherNames': ['5-FU', 'Adrucil', 'Efudex'], 'description': '500 mg/m2 by vein on day 1 for 4 cycles (21 day cycle) at preference of treating physicians.', 'armGroupLabels': ['Eribulin + FEC or FAC Group', 'Paclitaxel + FEC or FAC Group']}, {'name': 'Epirubicin', 'type': 'DRUG', 'otherNames': ['Ellence'], 'description': '100 mg/m2 by vein on day 1 for 4 cycles (21 day cycle) at preference of treating physicians.', 'armGroupLabels': ['Eribulin + FEC or FAC Group', 'Paclitaxel + FEC or FAC Group']}, {'name': 'Cyclophosphamide', 'type': 'DRUG', 'otherNames': ['Cytoxan', 'Neosar'], 'description': '500 mg/m2 by vein on day 1 for 4 cycles (21 day cycle) at preference of treating physicians.', 'armGroupLabels': ['Eribulin + FEC or FAC Group', 'Paclitaxel + FEC or FAC Group']}, {'name': 'Doxorubicin', 'type': 'DRUG', 'otherNames': ['Doxorubicin Hydrochloride', 'Adriamycin PFS', 'Adriamycin RDF', 'Adriamycin', 'Rubex'], 'description': '50 mg/m2 by vein on day 1, over 72 hour continuous infusion or intravenous bolus, for 4 cycles (21 day cycle) at preference of treating physicians.', 'armGroupLabels': ['Eribulin + FEC or FAC Group', 'Paclitaxel + FEC or FAC Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas MD Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Vicente Valero, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'M.D. Anderson Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'M.D. Anderson Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Eisai Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}