Ignite Creation Date:
2025-12-24 @ 9:21 PM
Ignite Modification Date:
2025-12-27 @ 11:09 AM
Study NCT ID:
NCT00028704
Status:
TERMINATED
Last Update Posted:
2012-07-18
First Post:
2002-01-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Breast-Conserving Therapy Compared With Mastectomy Followed By Radiation Therapy in Treating Women With Locally Advanced Breast Cancer Previously Treated With Chemotherapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D058922', 'term': 'Inflammatory 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': 'D011878', 'term': 'Radiotherapy'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26}}, 'statusModule': {'whyStopped': 'low accrual', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2001-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-07', 'lastUpdateSubmitDate': '2012-07-17', 'studyFirstSubmitDate': '2002-01-04', 'studyFirstSubmitQcDate': '2003-01-26', 'lastUpdatePostDateStruct': {'date': '2012-07-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-01-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2003-12', 'type': 'ACTUAL'}}, 'conditionsModule': {'keywords': ['stage II breast cancer', 'stage IIIA breast cancer', 'stage IIIB breast cancer', 'inflammatory breast cancer'], 'conditions': ['Breast Cancer']}, 'referencesModule': {'references': [{'pmid': '16274985', 'type': 'RESULT', 'citation': 'Sinacki M, Jassem J, van Tienhoven G. Conservative local treatment versus mastectomy after induction chemotherapy in locally advanced breast cancer: a randomised phase III study (EORTC 10974/22002, LAMANOMA)--why did this study fail? Eur J Cancer. 2005 Dec;41(18):2787-8. doi: 10.1016/j.ejca.2005.06.027. Epub 2005 Nov 7. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'RATIONALE: Breast-conserving treatments such as radiation therapy or limited surgery are less invasive than mastectomy and may improve the quality of life. It is not yet known if breast-conserving treatments are as effective as mastectomy followed by radiation therapy in treating locally advanced breast cancer.\n\nPURPOSE: Randomized phase III trial to compare the effectiveness of breast-conserving therapy with mastectomy followed by radiation therapy in treating women who have locally advanced breast cancer that has been previously treated with chemotherapy.', 'detailedDescription': 'OBJECTIVES:\n\n* Compare the overall survival and time to loco-regional failure in women with locally advanced breast cancer treated with breast-conserving local therapy vs mastectomy followed by radiotherapy after they have received prior induction chemotherapy.\n* Compare the quality of life of patients treated with these regimens.\n\nOUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center, initial stage (T0, T1, T2, T3, or Tx vs T4), response to prior induction chemotherapy (complete response (CR) vs other), and menopausal status (premenopausal vs postmenopausal). Patients are randomized to 1 of 2 treatment arms.\n\n* Arm I: Patients undergo mastectomy followed by radiotherapy.\n* Arm II: Patients receive breast-conserving treatment comprising 1 of 3 of the following therapeutic options:\n\n * Regimen A: Patients receive radiotherapy alone.\n * Regimen B: Patients with a partial response (PR) to prior induction chemotherapy undergo limited surgery followed by radiotherapy. Patients with a CR to prior induction chemotherapy undergo radiotherapy alone.\n * Regimen C: Patients with a partial response (PR) or CR to prior induction chemotherapy undergo radiotherapy alone.\n\nPatients with a CR to radiotherapy receive no further treatment. Patients with a PR to radiotherapy undergo limited surgery.\n\nQuality of life is assessed at baseline, at the end of therapy, every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.\n\nPatients are followed within 1 month, every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.\n\nPROJECTED ACCRUAL: A total of 1,300 patients (650 per treatment arm) will be accrued for this study within 5 years.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically or cytologically confirmed locally advanced breast cancer\n\n * T3 inoperable, N0-N2\n * Any T, N2\n * T4, N0-N2\n * Inflammatory breast carcinoma\n* Prior treatment with 4-6 courses of standard induction chemotherapy or active investigational regimens completed within the past 4 weeks\n* Residual tumor size less than 5 cm\n* No fixed axillary lymph nodes\n* No multifocal or bilateral breast cancer\n* No clinical suspicion of extensive ductal carcinoma in situ\n* No unresolved skin edema\n* No distant metastases (including ipsilateral supraclavicular node)\n\n * Positive bone scan allowed provided there are no bone metastases on x-ray\n* Hormone receptor status:\n\n * Not specified\n\nPATIENT CHARACTERISTICS:\n\nAge:\n\n* Any age\n\nSex:\n\n* Female\n\nMenopausal status:\n\n* Not specified\n\nPerformance status:\n\n* WHO 0-1\n\nLife expectancy:\n\n* Not specified\n\nHematopoietic:\n\n* Neutrophil count at least 2,000/mm\\^3\n* Platelet count at least 100,000/mm\\^3\n\nHepatic:\n\n* Bilirubin less than 1.5 times normal\n* SGOT and SGPT no greater than 2 times normal\n* Alkaline phosphatase no greater than 2 times normal\n\nRenal:\n\n* Creatinine less than 1.5 times normal\n\nOther:\n\n* No other prior or concurrent malignancy except adequately treated squamous cell or basal cell skin cancer or adequately treated cone-biopsied carcinoma in situ of the cervix\n* No serious underlying medical illness that would preclude study\n* No psychiatric or addictive disorder that would preclude study\n* No contraindication to study treatment\n* Not pregnant\n* Fertile patients must use effective barrier contraception\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy:\n\n* Not specified\n\nChemotherapy:\n\n* See Disease Characteristics\n\nEndocrine therapy:\n\n* No concurrent hormonal replacement therapy\n* No concurrent oral contraceptives\n\nRadiotherapy:\n\n* See Disease Characteristics\n* No prior radiotherapy for breast cancer\n\nSurgery:\n\n* No prior surgery for breast cancer other than biopsy for diagnosis confirmation\n\nOther:\n\n* No other prior systemic therapy for breast cancer'}, 'identificationModule': {'nctId': 'NCT00028704', 'briefTitle': 'Breast-Conserving Therapy Compared With Mastectomy Followed By Radiation Therapy in Treating Women With Locally Advanced Breast Cancer Previously Treated With Chemotherapy', 'organization': {'class': 'NETWORK', 'fullName': 'European Organisation for Research and Treatment of Cancer - EORTC'}, 'officialTitle': 'Conservative Local Treatment Versus Mastectomy After Induction Chemotherapy In Locally Advanced Breast Cancer: A Randomized Phase III Study', 'orgStudyIdInfo': {'id': 'EORTC-10974-22002'}, 'secondaryIdInfos': [{'id': 'EORTC-10974'}, {'id': 'CEEOG-EORTC-10974'}, {'id': 'EORTC-22002'}, {'id': 'GOCCHI-EORTC-10974'}, {'id': 'ICCG-EORTC-10974'}, {'id': 'EORTC-BIG-0002'}, {'id': 'LAMANOMA'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'conventional surgery', 'type': 'PROCEDURE'}, {'name': 'radiation therapy', 'type': 'RADIATION'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'B-1050', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'Centre Hospitalier Etterbeek Ixelles', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': 'B-3000', 'city': 'Leuven', 'country': 'Belgium', 'facility': 'U.Z. Gasthuisberg', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}, {'zip': '10', 'city': 'Santiago', 'country': 'Chile', 'facility': 'Instituto de Radiomedicina', 'geoPoint': {'lat': -33.45694, 'lon': -70.64827}}, {'zip': '31096', 'city': 'Haifa', 'country': 'Israel', 'facility': 'Rambam Medical Center', 'geoPoint': {'lat': 32.81303, 'lon': 34.99928}}, {'zip': '1105 AZ', 'city': 'Amsterdam', 'country': 'Netherlands', 'facility': 'Akademisch Medisch Centrum', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'zip': '6815 AD', 'city': 'Arnhem', 'country': 'Netherlands', 'facility': 'Arnhems Radiotherapeutisch Instituut', 'geoPoint': {'lat': 51.98, 'lon': 5.91111}}, {'zip': '2300 CA', 'city': 'Leiden', 'country': 'Netherlands', 'facility': 'Leiden University Medical Center', 'geoPoint': {'lat': 52.15833, 'lon': 4.49306}}, {'zip': '5042 SB', 'city': 'Tilburg', 'country': 'Netherlands', 'facility': 'Dr. Bernard Verbeeten Instituut', 'geoPoint': {'lat': 51.55551, 'lon': 5.0913}}, {'zip': '80-211', 'city': 'Gdansk', 'country': 'Poland', 'facility': 'Medical University of Gdansk', 'geoPoint': {'lat': 54.35227, 'lon': 18.64912}}, {'zip': '60-355', 'city': 'Poznan', 'country': 'Poland', 'facility': 'Karol Marcinkowski University', 'geoPoint': {'lat': 52.40692, 'lon': 16.92993}}, {'zip': '02-781', 'city': 'Warsaw', 'country': 'Poland', 'facility': 'Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'zip': '3049', 'city': 'Coimbra', 'country': 'Portugal', 'facility': 'Hospitais da Universidade de Coimbra (HUC)', 'geoPoint': {'lat': 40.20686, 'lon': -8.41996}}, {'zip': 'W6 8RF', 'city': 'London', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Charing Cross Hospital', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Jacek Jassem, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Medical University of Gdansk'}, {'name': 'G. van Tienhoven, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)'}, {'name': 'Marzena Welnicka-Jaskiewicz, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Medical University of Gdansk'}, {'name': 'Rodrigo Arriagada, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Instituto de Radiomedicina'}, {'name': 'Marie Emson, BSc', 'role': 'STUDY_CHAIR', 'affiliation': 'International Collaborative Cancer Group'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'European Organisation for Research and Treatment of Cancer - EORTC', 'class': 'NETWORK'}, 'collaborators': [{'name': 'Central and Eastern European Oncology Group', 'class': 'OTHER'}, {'name': 'Grupo Oncologico Cooperativo Chileno de Investigation', 'class': 'NETWORK'}, {'name': 'International Collaborative Cancer Group', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}