Ignite Creation Date:
2025-12-25 @ 3:18 AM
Ignite Modification Date:
2025-12-26 @ 1:56 AM
Study NCT ID:
NCT00005605
Status:
COMPLETED
Last Update Posted:
2011-02-21
First Post:
2000-05-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Tamoxifen to Prevent Bone Loss and Heart Disease in Premenopausal Women Receiving Chemotherapy for Stage I or Stage II Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D010024', 'term': 'Osteoporosis'}], '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'}, {'id': 'D001851', 'term': 'Bone Diseases, Metabolic'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 79}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2000-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-02', 'completionDateStruct': {'date': '2005-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-02-18', 'studyFirstSubmitDate': '2000-05-02', 'studyFirstSubmitQcDate': '2003-01-26', 'lastUpdatePostDateStruct': {'date': '2011-02-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-01-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-10', 'type': 'ACTUAL'}}, 'conditionsModule': {'keywords': ['osteoporosis', 'stage I breast cancer', 'stage II breast cancer'], 'conditions': ['Breast Cancer', 'Osteoporosis']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Tamoxifen may be able to increase bone density and decrease cholesterol in women who are undergoing chemotherapy for breast cancer.\n\nPURPOSE: Clinical trial to study the effectiveness of tamoxifen in preventing bone loss and heart disease caused by chemotherapy treatment in premenopausal women who have stage I or stage II breast cancer.', 'detailedDescription': 'OBJECTIVES:\n\n* Compare the bone density in the femoral neck and lumbar spine and cholesterol levels in premenopausal women with stage I or II breast cancer treated with adjuvant chemotherapy with or without tamoxifen.\n* Collect information regarding breast cancer risk factors, treatment, pathology, diet, activity levels, weight, and smoking in these patients.\n\nOUTLINE: Patients are stratified according to type of treatment (adjuvant chemotherapy plus tamoxifen vs adjuvant chemotherapy alone).\n\nPatients receive adjuvant chemotherapy with or without oral tamoxifen at the discretion of the treating physician.\n\nPrior to starting chemotherapy, patients undergo blood draw to measure baseline levels of follicle-stimulating hormone, estradiol, total cholesterol, high-density lipoproteins, and low-density lipoproteins. Patients undergo baseline bone densitometry of the femoral neck and lumbar spine to assess bone density prior to starting chemotherapy or within 30 days of the first drug treatment. Laboratory studies and bone densitometry are repeated at years 1 and 2. A comparison is made between the study findings at baseline and at years 1 and 2.\n\nPROJECTED ACCRUAL: A total of 80 patients (40 per stratum) will be accrued for this study.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '35 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with stage I or II breast cancer currently undergoing treatment with either chemotherapy or tamoxifen.', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically proven stage I or II breast cancer\n* Must be scheduled to receive adjuvant chemotherapy with or without tamoxifen\n* Hormone receptor status:\n\n * Not specified\n\nPATIENT CHARACTERISTICS:\n\nAge:\n\n* 35 to 50\n\nSex:\n\n* Female\n\nMenopausal status:\n\n* Premenopausal by follicle-stimulating hormone and estradiol levels\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* Not pregnant\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy:\n\n* Not specified\n\nChemotherapy:\n\n* See Disease Characteristics\n\nEndocrine therapy:\n\n* See Disease characteristics\n\nRadiotherapy:\n\n* Not specified\n\nSurgery:\n\n* Not specified'}, 'identificationModule': {'nctId': 'NCT00005605', 'briefTitle': 'Tamoxifen to Prevent Bone Loss and Heart Disease in Premenopausal Women Receiving Chemotherapy for Stage I or Stage II Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Northwestern University'}, 'officialTitle': 'Does Tamoxifen Prevent the Skeletal and Cardiovascular Morbidity of Chemotherapy in Premenopausal Women?', 'orgStudyIdInfo': {'id': 'NU 95B2'}, 'secondaryIdInfos': [{'id': 'NU-95B2'}, {'id': 'NCI-G00-1737'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Tamoxifen group'}, {'label': 'Chemotherapy group'}]}, 'contactsLocationsModule': {'locations': [{'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Robert H. Lurie Comprehensive Cancer Center at Northwestern University', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'overallOfficials': [{'name': 'Seema A. Khan, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Robert H. Lurie Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Northwestern University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'oldNameTitle': 'Seema Khan, MD', 'oldOrganization': 'Northwestern University'}}}}