Ignite Creation Date:
2025-12-25 @ 4:16 AM
Ignite Modification Date:
2025-12-26 @ 3:16 AM
Study NCT ID:
NCT00002720
Status:
COMPLETED
Last Update Posted:
2013-09-20
First Post:
1999-11-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Surgery With or Without Lymph Node Removal in Treating Older Women With Stage I Breast Cancer
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': 'D013629', 'term': 'Tamoxifen'}], 'ancestors': [{'id': 'D013267', 'term': 'Stilbenes'}, {'id': 'D001597', 'term': 'Benzylidene Compounds'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 642}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1995-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2000-08', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-09-19', 'studyFirstSubmitDate': '1999-11-01', 'studyFirstSubmitQcDate': '2003-01-26', 'lastUpdatePostDateStruct': {'date': '2013-09-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-01-27', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['stage I breast cancer'], 'conditions': ['Breast Cancer']}, 'referencesModule': {'references': [{'pmid': '23154393', 'type': 'DERIVED', 'citation': 'Martelli G, Boracchi P, Ardoino I, Lozza L, Bohm S, Vetrella G, Agresti R. Axillary dissection versus no axillary dissection in older patients with T1N0 breast cancer: 15-year results of a randomized controlled trial. Ann Surg. 2012 Dec;256(6):920-4. doi: 10.1097/SLA.0b013e31827660a8.'}]}, 'descriptionModule': {'briefSummary': 'RATIONALE: Surgery to remove axillary lymph nodes may be an effective treatment for women with breast cancer.\n\nPURPOSE: Randomized phase III trial to compare the effectiveness of therapy with or without axillary lymph node dissection following quadrantectomy in treating older women with stage I breast cancer that is estrogen receptor positive.', 'detailedDescription': 'OBJECTIVES:\n\n* Compare the efficacy of quadrantectomy with or without axillary lymph node dissection, followed by tamoxifen in terms of local and distant relapse rates and overall survival of patients with stage I, invasive breast cancer.\n* Determine the relationship between biological variables, such as hormone receptor status, cell proliferation, and DNA ploidy, and the clinical outcome of the disease in these patients.\n\nOUTLINE: This is a randomized, multicenter study. Patients are stratified by center. Patients are randomized to 1 of 2 treatment arms.\n\n* Arm I: Patients undergo quadrantectomy with dissection of level I and II axillary lymph nodes.\n* Arm II: Patients undergo quadrantectomy without axillary lymph node dissection. Patients on both arms receive tamoxifen daily for 5 years.\n\nPatients are followed every 4 months for 2 years, every 6 months for 2 years, and then annually thereafter.\n\nPROJECTED ACCRUAL: A total of 642 patients will be accrued for this study within 3 years.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically proven stage I, invasive breast cancer\n* Hormone receptor status:\n\n * Estrogen receptor positive\n * Progesterone receptor positive or negative\n\nPATIENT CHARACTERISTICS:\n\nAge:\n\n* 65 to 80\n\nSex:\n\n* Female\n\nMenopausal status:\n\n* Postmenopausal\n\nPerformance status:\n\n* Not specified\n\nLife Expectancy:\n\n* Not specified\n\nHematopoietic:\n\n* Not specified\n\nHepatic:\n\n* Not specified\n\nRenal:\n\n* Not specified\n\nOther:\n\n* No serious disease that would preclude surgery\n* No other prior or concurrent malignancy except basal cell carcinoma or carcinoma in situ of the cervix\n\nPRIOR CONCURRENT THERAPY:\n\n* Not specified'}, 'identificationModule': {'nctId': 'NCT00002720', 'briefTitle': 'Surgery With or Without Lymph Node Removal in Treating Older Women With Stage I Breast Cancer', 'organization': {'class': 'NIH', 'fullName': 'National Cancer Institute (NCI)'}, 'officialTitle': 'QUADRANTECTOMY PLUS AXILLARY DISSECTION VERSUS QUADRANTECTOMY ALONE IN MAMMOGRAPHIC STAGE T1N0 BREAST CANCER PATIENTS AGED OVER 65 YEARS', 'orgStudyIdInfo': {'id': 'CDR0000064573'}, 'secondaryIdInfos': [{'id': 'CNR-9502'}, {'id': 'EU-95020'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'tamoxifen citrate', 'type': 'DRUG'}, {'name': 'conventional surgery', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '20133', 'city': 'Milano (Milan)', 'country': 'Italy', 'facility': 'Istituto Nazionale per lo Studio e la Cura dei Tumori', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}], 'overallOfficials': [{'name': 'Gabriele Martelli, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Fondazione IRCCS Istituto Nazionale dei Tumori, Milano'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'European Institute of Oncology', 'class': 'OTHER'}}}}