Ignite Creation Date:
2025-12-24 @ 5:14 PM
Ignite Modification Date:
2025-12-30 @ 5:02 AM
Study NCT ID:
NCT00031850
Status:
COMPLETED
Last Update Posted:
2013-06-26
First Post:
2002-03-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Raloxifene and Goserelin in Preventing Breast Cancer in Women With a Family History of 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': 'D017273', 'term': 'Goserelin'}, {'id': 'D020849', 'term': 'Raloxifene Hydrochloride'}], 'ancestors': [{'id': 'D007987', 'term': 'Gonadotropin-Releasing Hormone'}, {'id': 'D010906', 'term': 'Pituitary Hormone-Releasing Hormones'}, {'id': 'D007028', 'term': 'Hypothalamic Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D009479', 'term': 'Neuropeptides'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D009842', 'term': 'Oligopeptides'}, {'id': 'D009419', 'term': 'Nerve Tissue Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D013629', 'term': 'Tamoxifen'}, {'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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'primaryPurpose': 'PREVENTION'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2000-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-05', 'completionDateStruct': {'date': '2007-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-06-25', 'studyFirstSubmitDate': '2002-03-08', 'studyFirstSubmitQcDate': '2003-01-26', 'lastUpdatePostDateStruct': {'date': '2013-06-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-01-27', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['breast cancer'], '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 raloxifene and goserelin may be effective in preventing breast cancer.\n\nPURPOSE: Randomized pilot study to study the effectiveness of combining raloxifene and goserelin in preventing breast cancer in women who have a family history of breast cancer.', 'detailedDescription': 'OBJECTIVES:\n\n* Compare the feasibility of raloxifene and goserelin versus no medical intervention in women at high genetic risk for developing breast cancer.\n* Compare the incidence of adverse effects in patients treated with these regimens.\n* Compare the effect of these regimens on bone density, biochemical markers of bone turnover, and lipid profiles in these patients.\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. Patients are randomized to one of two treatment arms.\n\n* Arm I: Patients receive goserelin subcutaneously once every month and oral raloxifene daily for 6-12 months.\n* Arm II: Patients are screened for breast cancer every 6 months. In both arms, patients undergo annual mammograms.\n\nQuality of life is assessed at baseline and at 1, 3, 6, and 12 months.\n\nPatients are followed for 5 years.\n\nPROJECTED ACCRUAL: A total of 150 patients (75 per treatment arm) will be accrued for this study.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* High genetic risk of developing breast cancer defined as one or more of the following:\n\n * BRCA1 or BRCA2 germ-line mutation\n * First-degree relative of known BRCA1 or BRCA2 mutation carrier\n * Family with 4 or more relatives diagnosed with female or male breast cancer or ovarian cancer before the age of 60\n * Two first-degree relatives diagnosed with breast cancer before the age of 40\n * p53 germ-line mutation (classical Li-Fraumeni syndrome (LFS) only)\n * First-degree relative of a carrier in a family with classical LFS\n * Risk equivalent to any of the above confirmed by clinical geneticist\n* No evidence of breast cancer by mammography\n\n * Suspicious lesions must be confirmed as non-malignant\n* No prior breast cancer\n* No prior prophylactic mastectomy\n* No plan for alternative prevention measures within the next 12 months\n* Hormone receptor status:\n\n * Not specified\n\nPATIENT CHARACTERISTICS:\n\nAge:\n\n* 30 to 45\n\nSex:\n\n* Female\n\nMenopausal status:\n\n* Premenopausal (follicle-stimulating hormone in premenopausal range if not menstruating)\n\nPerformance status:\n\n* Not specified\n\nLife expectancy:\n\n* More than 10 years (excluding breast cancer risk)\n\nHematopoietic:\n\n* Not specified\n\nHepatic:\n\n* Adequate liver function\n\nRenal:\n\n* Adequate renal function\n\nCardiovascular:\n\n* No prior deep vein thrombosis\n\nPulmonary:\n\n* No prior pulmonary embolism\n\nOther:\n\n* Not pregnant\n* Fertile patients must use effective nonhormonal contraception\n* No psychological disorder that would preclude study compliance\n* No prior malignancy within the past 5 years except curatively treated nonmelanoma skin cancer or cervical cancer\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy:\n\n* Not specified\n\nChemotherapy:\n\n* Not specified\n\nEndocrine therapy:\n\n* No concurrent hormonal therapy (e.g., oral contraception or hormone replacement therapy)\n\nRadiotherapy:\n\n* Not specified\n\nSurgery:\n\n* See Disease Characteristics\n\nOther:\n\n* At least 30 days or 5 half-lives since prior investigational drugs\n* No concurrent anticoagulants'}, 'identificationModule': {'nctId': 'NCT00031850', 'briefTitle': 'Raloxifene and Goserelin in Preventing Breast Cancer in Women With a Family History of Breast Cancer', 'organization': {'class': 'NIH', 'fullName': 'National Cancer Institute (NCI)'}, 'officialTitle': 'A Randomized Trial Of Raloxifene Plus Zoladex For Prevention Of Breast Cancer', 'orgStudyIdInfo': {'id': 'NCRI-IBIS-RAZOR'}, 'secondaryIdInfos': [{'id': 'CDR0000069233', 'type': 'REGISTRY', 'domain': 'PDQ (Physician Data Query)'}, {'id': 'EU-20053'}, {'id': 'UKCCCR-IBIS-RAZOR'}, {'id': 'ISRCTN17775670'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'goserelin acetate', 'type': 'DRUG'}, {'name': 'raloxifene', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M20 4BX', 'city': 'Manchester', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Christie Hospital NHS Trust', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}], 'overallOfficials': [{'name': 'Anthony Howell, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'The Christie NHS Foundation Trust'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institute of Cancer Research, United Kingdom', 'class': 'OTHER'}}}}