Status:
ACTIVE_NOT_RECRUITING
Deslorelin Combined With Low-Dose Add-Back Estradiol and Testosterone in Preventing Breast Cancer in Premenopausal Women Who Are at High Risk for This Disease
Lead Sponsor:
City of Hope Medical Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
brca1 Mutation Carrier
brca2 Mutation Carrier
Eligibility:
FEMALE
21-48 years
Phase:
PHASE2
Brief Summary
RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. Deslorelin combined with low-dose add-back estradiol and testosterone (given t...
Detailed Description
OBJECTIVES: I. Assess the effects on the breast of treatment with the gonadotropin-releasing hormone agonist (GnRHA)-based regimen in breast cancer (BRCA) gene mutation carriers, including correlatio...
Eligibility Criteria
Inclusion
- Patients must generally be in good health with lab values and physical examination within normal limits
- Known high risk of breast cancer due to BRCA mutation or empiric risk \> 30% lifetime by the Claus model
- No evidence or history of pervious cancer, except non-melanoma skin cancer
- Premenopausal women planning risk reduction mastectomy in 6 months or more (Group 1) or continued surveillance (Group 2)
- Prior tubal ligation or willing to use a non-hormonal barrier method of contraception
- Signed the Informed Consent Form document for this study in accordance with all Federal, State and Institutional regulations
- Must be current non-smoker
Exclusion
- GnRHA treatment within 12 months of study entry
- Nasal polyposis, atrophic rhinitis, severe allergic or vasomotor rhinitis, or sinusitis requiring current treatment or treatment for more than 3 months in the previous year
- Concurrent medications including: corticosteroids (prednisone, prednisolone, cortisone acetate, Decadron, Deltasone, hydrocortisone, Hydrocortone, Medrol), estrogens, progestins or androgens, including oral, implanted, or injected contraceptive; (At least 6 months must have elapsed since the last use of an implanted or injected contraceptive such as Norplant)
- Pregnant or breast-feeding or have been so in the last six months
- Immeasurable breast density on mammogram
Key Trial Info
Start Date :
March 11 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 15 2024
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT00080756
Start Date
March 11 2004
End Date
October 15 2024
Last Update
August 28 2024
Active Locations (1)
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1
City of Hope Medical Center
Duarte, California, United States, 91010-3000