Ignite Creation Date:
2025-12-25 @ 3:26 AM
Ignite Modification Date:
2026-03-01 @ 5:38 PM
Study NCT ID:
NCT00544505
Status:
UNKNOWN
Last Update Posted:
2011-12-13
First Post:
2007-10-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pre-operative Chemotherapy in Operable Breast Cancer, Phase III Study Comparing a Short Intensive Pre-operative Chemotherapy With the Same Therapy Initiated Shortly After Surgery(Peri-operatively)(POCOB)EORTC 10902)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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': 'D005472', 'term': 'Fluorouracil'}, {'id': 'C098534', 'term': 'EC regimen'}], 'ancestors': [{'id': 'D014498', 'term': 'Uracil'}, {'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2007-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-12', 'completionDateStruct': {'date': '2013-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-12-11', 'studyFirstSubmitDate': '2007-10-15', 'studyFirstSubmitQcDate': '2007-10-15', 'lastUpdatePostDateStruct': {'date': '2011-12-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-10-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy', 'timeFrame': 'overall'}]}, 'conditionsModule': {'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'Pre-operative chemotherapy in operable breast cancer, phase III study comparing a short intensive pre-operative chemotherapy with the same therapy initiated shortly after surgery (peri-operatively) (POCOB) (EORTC 10902)'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nDisease Characteristics:\n\n* Palpable, operable breast cancer that has been diagnosed by core needle biopsy (mandatory for T1c tumors) or fine needle aspiration within 21 days prior to entry\n* Stage T1c-4b, N0-1, M0\n\nHormone receptor status:\n\n* Not specified\n* No bilateral breast cancer\n\nPrior/Concurrent Therapy:\n\n* No previous treatment for breast cancer\n\nBiologic therapy:\n\n* Not specified\n\nChemotherapy:\n\n* No previous chemotherapy\n\nEndocrine therapy:\n\n* Not specified\n\nRadiotherapy:\n\n* Not specified\n\nSurgery:\n\n* Core needle biopsy or fine needle aspiration within 21 days prior to entry\n* Repeated core needle biopsy permitted\n\nPatient Characteristics:\n\nAge:\n\n* 16 to 70\n\nSex:\n\n* Women only\n\nMenopausal status:\n\n* Not specified\n\nPerformance status:\n\n* WHO 0-2\n\nHematopoietic:\n\n* WBC at least 4,000\n* Platelets at least 100,000\n\nHepatic:\n\n* Bilirubin no greater than 2.8 mg/dL (50 micromoles/L)\n\nRenal:\n\n* Creatinine no greater than 1.3 mg/dL (120 micromoles/L)\n\nCardiovascular:\n\n* No congestive heart failure\n* No significant arrhythmia\n* No bilateral bundle branch block\n* No recent myocardial infarction\n* No uncontrolled hypertension (diastolic pressure greater than 110 mm Hg)\n\nOther:\n\n* No male breast cancer\n* No pregnant or nursing women\n* No second malignancy except adequately treated:\n\n * Nonmelanomatous skin cancer\n * Cervical cancer'}, 'identificationModule': {'nctId': 'NCT00544505', 'briefTitle': 'Pre-operative Chemotherapy in Operable Breast Cancer, Phase III Study Comparing a Short Intensive Pre-operative Chemotherapy With the Same Therapy Initiated Shortly After Surgery(Peri-operatively)(POCOB)EORTC 10902)', 'organization': {'class': 'OTHER', 'fullName': 'King Faisal Specialist Hospital & Research Center'}, 'orgStudyIdInfo': {'id': 'RAC#931-006'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Fluorouracil/Epirubicin/Cyclophosphamide', 'type': 'DRUG', 'description': 'Phase III Comparison of Preoperative vs Postoperative FEC (Fluorouracil/Epirubicin/Cyclophosphamide) in Women with Operable Breast Cancer'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Adnan Ezzat, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'King Faisal Specialist Hospital & Research Center, Riyadh, Saudi Arabia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'King Faisal Specialist Hospital & Research Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}