Clinical trial · Interventional
Bexarotene in Preventing Breast Cancer in Women at Genetic Risk
A Multicenter Randomized Double-Blind Trial Of Targretin Capsules Modifying Immunophenotypic Markers Related To Breast Cancer Progression In Breast Tissue From Genetically Identified High Risk Patients
NCT00055991CI-TRIAL-00009326completedPhase 1ClinicalTrials.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 uses certain drugs to try to prevent the development or recurrence of cancer. It is not yet known whether bexarotene is effective in preventing breast cancer. PURPOSE: Randomized clinical trial to study the effectiveness of bexarotene in preventing breast cancer in women who are at genetic risk of developing 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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| bexarotene | Drug | Bexarotene | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Bexarotene
- description
- Bexarotene / Targretin
- interventionNames
- Drug: bexarotene
- type
- PLACEBO_COMPARATOR
- label
- Sugar Pill
- description
- Sugar pill / placebo
- interventionNames
- Drug: bexarotene
Primary outcomes (1)
- measure
- Chemopreventive effect as determine by a modification of the immunophenotypic characteristics of normal breast tissue at day 29 during study treatment and day 30 after study completion
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Known carrier of a BRCA-1 or BRCA-2 mutation * Copy of laboratory report stating results must be available for review OR * At risk for carrying a BRCA-1 or BRCA-2 mutation * At least 10% risk by Parmigiana probability model * Must have at least 1 breast that has never been involved with cancer and has not been irradiated * Hormone receptor status: * Not specified PATIENT CHARACTERISTICS: Age * 18 and over Sex * Female Menopausal status * Not specified Performance status * Not specified Life expectancy * Not specified Hematopoietic * WBC greater than 4,000/mm\^3 * Platelet count greater than 100,000/mm\^3 * Hematocrit greater than 30% Hepatic * Bilirubin no greater than 1.5 times upper limit of normal (ULN) * ALT no greater than 1.5 times ULN * Alkaline phosphatase no greater than 1.5 times ULN * Albumin no greater than 1.5 times ULN * No biliary tract disease Renal * Creatinine no greater than 1.5 times ULN Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception for 1 month before, during, and for 1 month after study therapy * Triglycerides normal * Thyroid-stimulating hormone and thyroxine normal * Willing to undergo 2 duplicate needle biopsies of the breast * Willing to undergo genetic testing for BRCA-1 and BRCA-2 * No uncontrolled hyperlipidemia * No nontoxic goiter or thyroid enlargement * No severe underlying chronic illness or disease * No uncontrolled diabetes * No history of pancreatitis * No cancer within the past year except skin cancer or carcinoma in situ of the cervix (defined from the date of first diagnosis) * No concurrent alcohol use (greater than 3 drinks or its equivalent per day) PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * More than 1 year since prior chemotherapy for a neoplasm Endocrine therapy * More than 3 months since prior postmenopausal hormonal therapy (including estrogens or progestins) * More than 3 months since prior tamoxifen or other selective estrogen-receptor modulators * No concurrent hormone replacement therapy * Concurrent thyroid hormone supplementation allowed Radiotherapy * See Disease Characteristics Surgery * Not specified Other * More than 30 days since prior investigational medications * More than 3 months since prior oral vitamin A supplements greater than the recommended daily requirement (5,000 IU) or therapeutic oral or topical vitamin A derivatives (e.g., isotretinoin) * No concurrent participation in a study of an investigational agent * No concurrent medications known to be associated with pancreatic toxicity or to increase triglyceride levels
References
Publications (0)
Data not yet available
No reference posted for this study.