Study on Using Deslorelin with Low-Dose Estradiol and Testosterone to Prevent Breast Cancer in Premenopausal Women at High Risk

Sponsor: City of Hope Medical Center

Sponsor score: 40

ClinicalTrials ID:NCT00080756

Provider View

This clinical trial is exploring whether a combination of the drug deslorelin with low doses of estradiol and testosterone can help prevent breast cancer in premenopausal women who are at high risk due to genetic factors or other reasons.

Patient Parameters

Program Overview

The study is investigating a prevention strategy for breast cancer using a combination of drugs. Deslorelin, along with low doses of estradiol and testosterone, is being tested to see if it can effectively prevent breast cancer in women who have not yet gone through menopause and are at high risk for the disease. The trial aims to understand how these drugs affect breast tissue and the overall quality of life for participants.

Description

This study involves two groups of premenopausal women who are at high risk for breast cancer.

  • Group 1: Participants will take deslorelin, estradiol, and testosterone through a nasal spray once a day for 6 months. After this period, they will undergo a planned surgery to reduce their risk of breast cancer.

  • Group 2: Participants will also take the same combination of drugs through a nasal spray once a day, but for 10 months. Instead of surgery, they will continue to be monitored closely for any changes in their breast health.

After completing the treatment, all participants will have follow-up visits every 6 months for 2 years to monitor their health and any effects of the treatment.

Eligibility Criteria

Inclusion Criteria

  • Generally in good health with normal lab results and physical exams.
  • High risk of breast cancer due to BRCA gene mutation or a lifetime risk greater than 30%.
  • No history of cancer, except for non-melanoma skin cancer.
  • Premenopausal women planning either risk-reducing surgery or continued monitoring.
  • Have had a tubal ligation or agree to use non-hormonal birth control.
  • Signed informed consent to participate in the study.
  • Must be a non-smoker.

Exclusion Criteria

  • Have used GnRHA treatment in the past year.
  • Have nasal conditions like polyps or chronic sinus issues requiring treatment.
  • Currently taking certain medications like corticosteroids or hormonal contraceptives.
  • Pregnant, breastfeeding, or have been in the last six months.
  • Cannot have breast density that is immeasurable on a mammogram.

Locations

FACILITYZIPCITYSTATE
City of Hope Medical Center91010-3000DuarteCalifornia

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