- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00080756
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
Biomarkers, Breast Density And Risk Reduction Perspectives In BRCA Carriers
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 to replace hormones suppressed by deslorelin) may be effective in preventing breast cancer in at-risk women.
PURPOSE: This phase II trial is studying how well giving deslorelin together with estradiol and testosterone works in preventing breast cancer in premenopausal women who are at high risk for this disease.
Study Overview
Status
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 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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
California
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Duarte, California, United States, 91010-3000
- City of Hope Comprehensive Cancer Center
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Los Angeles, California, United States, 90089-9181
- USC/Norris Comprehensive Cancer Center and Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Group 1 (planned risk reduction mastectomy)
Patients receive deslorelin, estradiol, and testosterone intranasally QD for 6 months.
Patients then undergo planned risk reduction mastectomy.
|
Correlative studies
Ancillary studies
0.35mg/100ul per day as a nasal spray
1mg/100ul per day as a nasal spray
0.275mg/100ul per day as a nasal spray
Undergo risk reduction mastectomy
|
Active Comparator: Group 2 (continued survaillance)
Patients receive deslorelin, estradiol, and testosterone intranasally QD for 10 months.
Patients then undergo continued surveillance through 10 months.
|
Correlative studies
Ancillary studies
0.35mg/100ul per day as a nasal spray
1mg/100ul per day as a nasal spray
0.275mg/100ul per day as a nasal spray
Undergo continued surveillance
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
Time Frame: Day 300
|
Day 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
Time Frame: 2 years
|
2 years
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Jeffrey Weitzel, MD, City of Hope Medical Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Skin Diseases
- Neoplasms
- Neoplasms by Site
- Breast Diseases
- Breast Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Estrogens
- Contraceptive Agents, Hormonal
- Contraceptive Agents
- Reproductive Control Agents
- Contraceptive Agents, Female
- Androgens
- Estradiol
- Testosterone
- Estradiol 17 beta-cypionate
- Estradiol 3-benzoate
- Polyestradiol phosphate
- Deslorelin
Other Study ID Numbers
- 02164
- P30CA033572 (U.S. NIH Grant/Contract)
- CHNMC-IRB-02164
- CDR0000355156 (Registry Identifier: NCI PDQ)
- NCI-2011-00975 (Registry Identifier: NCI CTRP)
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