Clinical trial · Interventional
Raloxifene and Goserelin in Preventing Breast Cancer in Women With a Family History of Breast Cancer
A Randomized Trial Of Raloxifene Plus Zoladex For Prevention Of Breast Cancer
NCT00031850CI-TRIAL-00011129completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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. PURPOSE: 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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| goserelin acetate | Drug | Goserelin | ALIAS |
| raloxifene | Drug | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 30 Years
- Maximum age
- 45 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * High genetic risk of developing breast cancer defined as one or more of the following: * BRCA1 or BRCA2 germ-line mutation * First-degree relative of known BRCA1 or BRCA2 mutation carrier * Family with 4 or more relatives diagnosed with female or male breast cancer or ovarian cancer before the age of 60 * Two first-degree relatives diagnosed with breast cancer before the age of 40 * p53 germ-line mutation (classical Li-Fraumeni syndrome (LFS) only) * First-degree relative of a carrier in a family with classical LFS * Risk equivalent to any of the above confirmed by clinical geneticist * No evidence of breast cancer by mammography * Suspicious lesions must be confirmed as non-malignant * No prior breast cancer * No prior prophylactic mastectomy * No plan for alternative prevention measures within the next 12 months * Hormone receptor status: * Not specified PATIENT CHARACTERISTICS: Age: * 30 to 45 Sex: * Female Menopausal status: * Premenopausal (follicle-stimulating hormone in premenopausal range if not menstruating) Performance status: * Not specified Life expectancy: * More than 10 years (excluding breast cancer risk) Hematopoietic: * Not specified Hepatic: * Adequate liver function Renal: * Adequate renal function Cardiovascular: * No prior deep vein thrombosis Pulmonary: * No prior pulmonary embolism Other: * Not pregnant * Fertile patients must use effective nonhormonal contraception * No psychological disorder that would preclude study compliance * No prior malignancy within the past 5 years except curatively treated nonmelanoma skin cancer or cervical cancer PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * Not specified Endocrine therapy: * No concurrent hormonal therapy (e.g., oral contraception or hormone replacement therapy) Radiotherapy: * Not specified Surgery: * See Disease Characteristics Other: * At least 30 days or 5 half-lives since prior investigational drugs * No concurrent anticoagulants
References
Publications (0)
Data not yet available
No reference posted for this study.