Overview

This trial is active, not recruiting.

Conditions brca1 mutation carrier, brca2 mutation carrier, breast cancer
Treatments therapeutic estradiol, deslorelin, therapeutic testosterone, therapeutic conventional surgery, active surveillance, quality-of-life assessment, laboratory biomarker analysis
Phase phase 2
Sponsor City of Hope Medical Center
Collaborator National Cancer Institute (NCI)
Start date February 2004
End date September 2017
Trial size 11 participants
Trial identifier NCT00080756, 02164, CDR0000355156, CHNMC-IRB-02164, NCI-2011-00975, P30CA033572

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 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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose prevention
Arm
(Experimental)
Patients receive deslorelin, estradiol, and testosterone intranasally QD for 6 months. Patients then undergo planned risk reduction mastectomy.
therapeutic estradiol
0.35mg/100ul per day as a nasal spray
deslorelin
1mg/100ul per day as a nasal spray
therapeutic testosterone
0.275mg/100ul per day as a nasal spray
therapeutic conventional surgery
Undergo risk reduction mastectomy
quality-of-life assessment
Ancillary studies
laboratory biomarker analysis
Correlative studies
(Active Comparator)
Patients receive deslorelin, estradiol, and testosterone intranasally QD for 10 months. Patients then undergo continued surveillance through 10 months.
therapeutic estradiol
0.35mg/100ul per day as a nasal spray
deslorelin
1mg/100ul per day as a nasal spray
therapeutic testosterone
0.275mg/100ul per day as a nasal spray
active surveillance
Undergo continued surveillance
quality-of-life assessment
Ancillary studies
laboratory biomarker analysis
Correlative studies

Primary Outcomes

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
time frame: 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

Eligibility Criteria

Female participants from 21 years up to 48 years old.

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

Additional Information

Official title Biomarkers, Breast Density And Risk Reduction Perspectives In BRCA Carriers
Principal investigator Jeffrey Weitzel, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by City of Hope Medical Center.