Biomarkers, Breast Density And Risk Reduction Perspectives In BRCA Carriers
21 Years
48 Years
Female
brca1 Mutation Carrier, brca2 Mutation Carrier, Breast Cancer
Trial Information
Biomarkers, Breast Density And Risk Reduction Perspectives In BRCA Carriers
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
correlation of changes in mammographic and magnetic resonance imaging (MRI) densities with
tissue morphometrics and biomarkers.
II. Evaluate perspectives about risk reduction options and impact on quality-of-life (QOL)
measures of participation in the chemopreventive protocol and in risk reduction surgery.
OUTLINE:
GROUP 1: Patients receive deslorelin, estradiol, and testosterone intranasally once daily
(QD) for 6 months. Patients then undergo planned risk reduction mastectomy.
GROUP 2: Patients receive deslorelin, estradiol, and testosterone intranasally QD for 10
months. Patients then undergo continued surveillance through 10 months.
After completion of study treatment, patients are followed up every 6 months for 2 years.
Inclusion Criteria:
- 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 Criteria:
- 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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Outcome Measure:
Treatment effects and correlation of changes in morphometrics and biomarkers as assessed by mammogram and magnetic resonance image (MRI) densities on days 1 and 300
Outcome Time Frame:
Day 300
Safety Issue:
No
Principal Investigator
Jeffrey Weitzel, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
City of Hope Medical Center
Authority:
United States: Food and Drug Administration
Study ID:
02164
NCT ID:
NCT00080756
Start Date:
February 2004
Completion Date:
Related Keywords:
- brca1 Mutation Carrier
- brca2 Mutation Carrier
- Breast Cancer
- breast cancer
- BRCA1 mutation carrier
- BRCA2 mutation carrier
- Breast Neoplasms
Name | Location |
|---|---|
| USC/Norris Comprehensive Cancer Center and Hospital | Los Angeles, California 90033-0804 |
| City of Hope Comprehensive Cancer Center | Duarte, California 91010 |
