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

Condition(s) targeted: brca1 Mutation Carrier; brca2 Mutation Carrier; Breast Cancer

Intervention: deslorelin (Drug); therapeutic estradiol (Drug); therapeutic testosterone (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: Beckman Research Institute

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.

Official title: Biomarkers, Breast Density And Risk Reduction Perspectives In BRCA Carriers

Study design: Prevention

Primary outcome:

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

Detailed description: 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.

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.

PROJECTED ACCRUAL: A total of 10 participants will be accrued for this study.

Minimum age: 21 Years. Maximum age: 48 Years. Gender(s): Female.

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:

- Not applicable

PATIENT CHARACTERISTICS:

Age

- 21 to 48

Sex

- Female

Menopausal status

- Premenopausal

Performance status

- Not specified

Life expectancy

- Not specified

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

PRIOR CONCURRENT THERAPY:

Biologic therapy

- Not specified

Chemotherapy

- Not specified

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

- Not specified

Surgery

- See Disease Characteristics

City of Hope Comprehensive Cancer Center, Duarte, California 91010-3000, United States; Recruiting
Clinical Trials Office - City of Hope Comprehensive Cancer Cen, Phone: 800-826-4673, Email: becomingapatient@coh.org

USC/Norris Comprehensive Cancer Center and Hospital, Los Angeles, California 90089-9181, United States; Recruiting
Clinical Trials Office - USC/Norris Comprehensive Cancer Cente, Phone: 323-865-0451

Clinical trial summary from the National Cancer Institute's PDQ® database

Starting date: February 2004
Last updated: August 29, 2008