Ignite Creation Date:
2025-12-24 @ 10:46 PM
Ignite Modification Date:
2026-01-06 @ 1:37 AM
Study NCT ID:
NCT00096369
Status:
TERMINATED
Last Update Posted:
2019-01-24
First Post:
2004-11-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tamoxifen in Preventing Breast Cancer in Women at Increased Risk for Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D000071960', 'term': 'Breast Carcinoma In Situ'}], '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': 'D002278', 'term': 'Carcinoma in Situ'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}]}, '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': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'PREVENTION'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 130}}, 'statusModule': {'whyStopped': 'accrual goal not met', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2000-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2007-03-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-22', 'studyFirstSubmitDate': '2004-11-09', 'studyFirstSubmitQcDate': '2004-11-08', 'lastUpdatePostDateStruct': {'date': '2019-01-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2004-11-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-03-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Plasma levels of hormones and binding proteins as measured by ELISA, IHC, and TUNEL at baseline and 3 months'}, {'measure': 'Markers of proliferation and apoptosis in breast cells as measured by quantitative MSP at baseline and 3 months'}, {'measure': 'Promoter-region methylation as assessed by microarrays at baseline and 3 months'}, {'measure': 'Gene expression'}]}, 'oversightModule': {'isFdaRegulatedDrug': True}, 'conditionsModule': {'keywords': ['breast cancer', 'lobular breast carcinoma in situ', 'breast cancer in situ'], 'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. The use of tamoxifen may be effective in preventing breast cancer.\n\nPURPOSE: This randomized phase II trial is studying tamoxifen to see how well it works compared to placebo in preventing breast cancer in women who are at increased risk for the disease.', 'detailedDescription': 'OBJECTIVES:\n\n* Compare molecular markers of proliferation and apoptosis in breast epithelial tissue of women at increased risk for breast cancer treated with tamoxifen vs placebo.\n* Compare the modulation of markers of genomic instability in breast epithelial tissue of patients treated with these drugs.\n* Compare serum levels of IGF-1, IGF-2, and IGFBP-3 of these patients at baseline and after treatment with these drugs.\n\nOUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to estimated 5-year breast cancer risk (1.67-5% vs ≥ 5%), presence of atypical ductal hyperplasia (yes vs no), and menopausal status (premenopausal vs postmenopausal). Patients are randomized to 1 of 2 treatment arms.\n\n* Arm I: Patients receive oral tamoxifen once daily.\n* Arm I: Patients receive oral placebo once daily. Treatment in both arms continues for 3 months in the absence of invasive breast cancer or unacceptable toxicity.\n\nPatients undergo core needle biopsy and fine needle aspiration biopsy at baseline and then at the completion of study treatment (for premenopausal patients); exactly 84 days after the first biopsy (for postmenopausal patients); or on the first or second day of the menstrual cycle on or after 84 days (during the third menstrual cycle) after the first dose of study medication (for patients with irregular menses).\n\nPatients are followed at 30 days.\n\nPROJECTED ACCRUAL: A total of 130 patients (65 per arm) will be accrued for this study within 30 months.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '120 Years', 'minimumAge': '35 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "DISEASE CHARACTERISTICS:\n\n* At increased risk for breast cancer, as defined by 1 of the following criteria:\n\n * Histologically confirmed lobular carcinoma in situ (LCIS) treated by local excision only\n * Composite increased breast cancer risk of ≥ 1.67% over 5 years, based on the following criteria:\n\n * Age\n * Number of first-degree female relatives with breast cancer\n * One or more prior breast biopsies\n\n * Fine-needle aspiration cytology of a non-cystic lesion in lieu of an open biopsy is considered a biopsy\n * Prior diagnosis of atypical hyperplasia of the breast\n * Age at first live birth\n * Nulliparity\n * Race\n * Age at onset of menarche\n* No prior or suspected invasive breast cancer or ductal carcinoma in situ\n* No clinical evidence of malignancy by physical examination, including a breast examination within the past 3 months\n* No evidence of suspicious or malignant disease or uncharacterized lesions on bilateral mammogram within the past 6 months\n* Normal gynecologic examination, including a bimanual pelvic examination and, if indicated, pap smear within the past 12 months\n* Hormone receptor status:\n\n * Not specified\n\nPATIENT CHARACTERISTICS:\n\nAge\n\n* 35 and over\n\nSex\n\n* Female\n\nMenopausal status\n\n* Premenopausal and ovulating\\*, defined as having regular menses for the past 6 months OR irregular menses with follicular phase (i.e., day 3) follicle-stimulating hormone level \\< 20 mIU/mL OR\n* Postmenopausal NOTE: \\* Ovulation is determined by day 21 progesterone level \\> 3 ng/mL\n\nPerformance status\n\n* ECOG 0-2\n\nLife expectancy\n\n* Not specified\n\nHematopoietic\n\n* Complete blood count normal\n* No active bleeding disorder (e.g., qualitative or quantitative platelet abnormality, hemophilia, or von Willebrand's disease)\n\nHepatic\n\n* Liver function tests normal\n\nRenal\n\n* Not specified\n\nCardiovascular\n\n* No prior deep-vein thrombosis except a single occurrence related to lower extremity trauma\n* No prior cerebral vascular accident\n* No prior transient ischemic attack\n\nPulmonary\n\n* No prior pulmonary embolus except a single occurrence related to lower extremity trauma\n\nOther\n\n* No saline or silicone breast implants\n* No known allergy to tamoxifen\n* No macular degeneration\n* No malignancy within the past 5 years except basal cell or squamous cell skin cancer or carcinoma in situ of the cervix\n* No nonmalignant disease that would preclude administration of tamoxifen\n* No psychiatric condition, including a history of clinical depression or addictive disorder, that would preclude giving informed consent or study compliance\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective nonhormonal contraception during and for 3 months after study participation\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy\n\n* Not specified\n\nChemotherapy\n\n* No prior systemic adjuvant chemotherapy for LCIS\n\nEndocrine therapy\n\n* No prior tamoxifen, raloxifene, or other selective estrogen-receptor modulators\n* At least 3 months since prior and no concurrent use of any of the following drugs:\n\n * Estrogen or progesterone replacement therapy\n * Oral contraceptives\n * Androgens\n * Luteinizing hormone-releasing hormone analogs\n * Prolactin inhibitors\n * Antiandrogens\n * Steroids\n* No concurrent steroids for asthma\n\nRadiotherapy\n\n* No prior radiotherapy for LCIS\n\nSurgery\n\n* No prior bilateral prophylactic mastectomy\n* No prior mastectomy for LCIS\n\nOther\n\n* Concurrent nonhormonal medications allowed\n* No concurrent warfarin or cholestyramine\n* No prior or concurrent participation in any other cancer prevention study\n\n * Patients treated with placebo on protocol NSABP-P-1 are eligible"}, 'identificationModule': {'nctId': 'NCT00096369', 'briefTitle': 'Tamoxifen in Preventing Breast Cancer in Women at Increased Risk for Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'University of Texas Southwestern Medical Center'}, 'officialTitle': 'An Exploratory Study to Identify Potential Surrogate Endpoint Biomarkers That Are Modulated by Tamoxifen vs. Placebo in Women With an Increased Risk for Breast Cancer', 'orgStudyIdInfo': {'id': 'CDR0000393444; V-10604'}}, 'armsInterventionsModule': {'interventions': [{'name': 'tamoxifen citrate', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '73104', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Oklahoma University Cancer Institute', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '75390', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '77030-4009', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'M.D. Anderson Cancer Center at University of Texas', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Cancer Therapy and Research Center', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}], 'overallOfficials': [{'name': 'David M. Euhus, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Simmons Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Texas Southwestern Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}