Ignite Creation Date:
2025-12-24 @ 10:58 PM
Ignite Modification Date:
2025-12-25 @ 8:26 PM
Study NCT ID:
NCT00309569
Status:
COMPLETED
Last Update Posted:
2020-10-14
First Post:
2006-03-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Randomized Study Comparing Pre- and Postoperative vs. Conventional Adjuvant Treatment in Receptor-negative Patients
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': 'D003520', 'term': 'Cyclophosphamide'}, {'id': 'D008727', 'term': 'Methotrexate'}, {'id': 'D005472', 'term': 'Fluorouracil'}, {'id': 'D015251', 'term': 'Epirubicin'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}], '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'}, {'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': 'D014498', 'term': 'Uracil'}, {'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D004317', 'term': 'Doxorubicin'}, {'id': 'D003630', 'term': 'Daunorubicin'}, {'id': 'D018943', 'term': 'Anthracyclines'}, {'id': 'D009279', 'term': 'Naphthacenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D000617', 'term': 'Aminoglycosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 429}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1991-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2000-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-13', 'studyFirstSubmitDate': '2006-03-31', 'studyFirstSubmitQcDate': '2006-03-31', 'lastUpdatePostDateStruct': {'date': '2020-10-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2006-04-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2000-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall survival'}, {'measure': 'Recurrence-free survival'}], 'secondaryOutcomes': [{'measure': 'Rate of breast-conserving procedures'}]}, 'conditionsModule': {'keywords': ['Cyclophosphamide', 'Methotrexate', 'Fluorouracil', 'Epirubicine', 'Breast Cancer'], 'conditions': ['Early Stage Breast Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.abcsg.at', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'Primarily, this clinical investigation compared overall survival and recurrence-free survival in patients with hormone receptor-negative breast cancer treated with pre- and postoperative chemotherapy vs. conventional postoperative treatment.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with bioptically verified breast cancer\n* Estrogen receptor-negative status\n* Age: \\< 70 years\n* WHO Performance Status \\< 2\n* Laboratory parameters\n\n 1. hematopoiesis: \\> 3500/mm3 leukocytes, \\> 100,000/mm3 thrombocytes\n 2. renal function: creatinin \\< 1.5mg%\n 3. hepatic function: GOT max. 2.5 x UNL\n 4. bilirubin: \\< 2.0 mg %\n 5. metabolic parameters: Na, Ca, K in normal range\n* \\</= 4 weeks interval since surgery\n* Informed consent\n\nExclusion Criteria:\n\n* Patients with locally inoperable cancer, M1\n* Other preoperative tumor-specific radiotherapy, chemotherapy or endocrine treatment\n* Pregnancy or lactation\n* General contraindication against cytostatic treatment\n* T4 cancer; inflammatory disease, simultaneous or sequential bilateral breast cancer\n* Lacking compliance or understanding of disease\n* Serious concomitant disease\n* Second carcinoma or status post second carcinoma (except for treated squamous cell carcinoma of the skin or cervical carcinoma in situ)'}, 'identificationModule': {'nctId': 'NCT00309569', 'briefTitle': 'Randomized Study Comparing Pre- and Postoperative vs. Conventional Adjuvant Treatment in Receptor-negative Patients', 'organization': {'class': 'NETWORK', 'fullName': 'Austrian Breast & Colorectal Cancer Study Group'}, 'officialTitle': 'A Randomized Phase III Study Comparing Pre- and Postoperative vs. Conventional Adjuvant Treatment Hormone Receptor-negative Breast Cancer Patients', 'orgStudyIdInfo': {'id': 'ABCSG-7'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A (pre- + postoperative chemotherapy)', 'description': '3 cycles CMF (cyclophophamide + Methotrexat + 5-Fluorouracil) followed by surgery. Subsequently node-positive patients received 3 cycles anthracycline-based chemotherapy regime EC (epirubicin + cyclophosphamide) and node-negative patients another 3 cycles CMF.', 'interventionNames': ['Drug: Cyclophosphamide', 'Drug: Methotrexate', 'Drug: Fluorouracil', 'Drug: Epirubicin', 'Other: Surgery']}, {'type': 'EXPERIMENTAL', 'label': 'B (conventional postoperative chemotherapy)', 'description': 'Surgery followed by 3 cycles CMF (cyclophophamide + Methotrexat + 5-Fluorouracil). Subsequently node-positive patients received 3 cycles anthracycline-based chemotherapy regime EC (epirubicin + cyclophosphamide) and node-negative patients another 3 cycles CMF.', 'interventionNames': ['Drug: Cyclophosphamide', 'Drug: Methotrexate', 'Drug: Fluorouracil', 'Drug: Epirubicin', 'Other: Surgery']}], 'interventions': [{'name': 'Cyclophosphamide', 'type': 'DRUG', 'description': 'Cyclophosphamide 600mg/m2', 'armGroupLabels': ['A (pre- + postoperative chemotherapy)', 'B (conventional postoperative chemotherapy)']}, {'name': 'Methotrexate', 'type': 'DRUG', 'description': 'Methotrexate 40mg/m2', 'armGroupLabels': ['A (pre- + postoperative chemotherapy)', 'B (conventional postoperative chemotherapy)']}, {'name': 'Fluorouracil', 'type': 'DRUG', 'description': 'Fluorouracil 600mg/m2', 'armGroupLabels': ['A (pre- + postoperative chemotherapy)', 'B (conventional postoperative chemotherapy)']}, {'name': 'Epirubicin', 'type': 'DRUG', 'description': 'Epirubucin 60mg/m2 (only node-positive patients)', 'armGroupLabels': ['A (pre- + postoperative chemotherapy)', 'B (conventional postoperative chemotherapy)']}, {'name': 'Surgery', 'type': 'OTHER', 'description': 'Surgery', 'armGroupLabels': ['A (pre- + postoperative chemotherapy)', 'B (conventional postoperative chemotherapy)']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Raimund Jakesz, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Austrian Breast & Colorectal Cancer Study Group'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Austrian Breast & Colorectal Cancer Study Group', 'class': 'NETWORK'}, 'responsibleParty': {'type': 'SPONSOR'}}}}