Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Trial Description

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.

Further Study Information

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.

Eligibility 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

Trial Contact Information

Trial Lead Organizations/Sponsors

City of Hope Comprehensive Cancer Center

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00080756
Information obtained from ClinicalTrials.gov on December 14, 2011

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