 |
Clinical Trial Questions?
|
|
|
Phase II Pilot Chemoprevention Study of Deslorelin in Combination With Low-Dose Add-Back Estradiol and Testosterone in Premenopausal Women With or Without a BRCA Gene Mutation Who Are at High Risk for Breast Cancer
Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information
Alternate Title
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
Basic Trial Information
| Phase | Type | Status | Age | Protocol IDs |
|---|
| Phase II | Prevention | Active | 21 to 48 | CHNMC-IRB-02164
NCT00080756 |
Special Category:
NCI Avon award trial Objectives - Determine the effects of deslorelin in combination with low-dose add-back estradiol and testosterone on the breast of premenopausal women with or without a BRCA gene mutation who are at high risk for breast cancer.
- Correlate changes in mammographic and MRI densities with tissue morphometrics and biomarkers in participants treated with this regimen.
- Determine cell proliferation and changes in estrogen receptor, progesterone receptor, or aromatase expression in participants treated with this regimen.
- Determine perspectives about risk reduction options in participants treated with this regimen.
- Determine the impact of this regimen on the quality of life of these participants.
- Analyze the expression of BRCA1 and BRCA2 in breast tissue of these participants before and after treatment with this regimen.
Entry Criteria Disease Characteristics:
- Known high risk of breast cancer due to a BRCA gene mutation OR empiric risk > 30% lifetime by the Claus model
- No immeasurable breast density on mammogram (BIRADS 1)
- Meets criteria for 1 of the following:
- Planning a risk-reduction mastectomy in 6 months or more
- Planning to continue surveillance
- Hormone receptor status:
Prior/Concurrent Therapy:
Biologic therapy Chemotherapy Endocrine therapy - More than 1 year since prior gonadotropin-releasing hormone agonist therapy
- At least 6 months since prior implanted or injected contraceptives
-
No concurrent corticosteroids
-
No other concurrent estrogens, progestins, or androgens, including oral, implanted, or injected contraceptives
Radiotherapy Surgery - See Disease Characteristics
Patient Characteristics:
Age Sex
Menopausal status
Performance status Life expectancy Hematopoietic - Hematopoietic function within normal limits
Hepatic - Hepatic function within normal limits
Renal - Renal function within normal limits
Other - In generally good health with normal laboratory values and physical examination
- Not pregnant or nursing
- No pregnancy or nursing within the past 6 months
- Negative pregnancy test
- Fertile patients must use effective nonhormonal barrier contraception
-
Non-smoker
-
No prior or suspected malignancy except nonmelanoma skin cancer
-
No nasal polyposis
-
No atrophic, severe allergic, or vasomotor rhinitis
- No sinusitis requiring current treatment or treatment for more than 3 months in the past year
Expected Enrollment 10A total of 10 participants will be accrued for this study. Outcomes Primary Outcome(s)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
Perspectives about risk reduction options and their impact on quality of life (QOL) as assessed by Medical Outcomes 36-item short-form version, Health Perceptions scale, and Body Image scale on days 1, 169, and 300, and then every 6 months for 2 years
Outline This is a pilot study.
Participants receive intranasal deslorelin, estradiol, and testosterone once daily for 6-10 months.
Quality of life is assessed at baseline, at 6 and 10 months, and then every 6 months until 2 years after study registration.
Trial Contact Information
Trial Lead Organizations City of Hope Comprehensive Cancer Center | | | | Clinical Trials Office - New Patient Services | | | |
Trial Sites
|
|
|
|
| U.S.A. |
|
| California |
|
| |
Duarte |
|
| | | | | | | | | City of Hope Comprehensive Cancer Center |
| | | Clinical Trials Office - City of Hope Comprehensive Cancer Center | |
| | Email:
becomingapatient@coh.org |
|
| |
Los Angeles |
|
| | | USC/Norris Comprehensive Cancer Center and Hospital |
| | | Clinical Trials Office - USC/Norris Comprehensive Cancer Center and Hospital | |
|
| Registry Information | | | Official Title | | Biomarkers, Breast Density And Risk Reduction Perspectives In BRCA Carriers | | | Trial Start Date | | 2004-02-04 | | | Trial Completion Date | | 2008-12-15 (estimated) | | | Registered in ClinicalTrials.gov | | NCT00080756 | | | Date Submitted to PDQ | | 2004-01-22 | | | Information Last Verified | | 2009-06-28 | | | NCI Grant/Contract Number | | CA33572 |
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.  Back to Top |
|
