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Deslorelin + Hormone Therapy for Breast Cancer Prevention in High-Risk Women
Study Summary
This trial is studying deslorelin combined with low-dose add-back estradiol and testosterone to see how well it works in preventing breast cancer in premenopausal women who are at high risk for this disease.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I haven't used steroids, hormones, or certain contraceptives in the last 6 months.I am at high risk for breast cancer due to a BRCA mutation or a lifetime risk over 30%.I have no history of cancer, except for non-melanoma skin cancer.I have received GnRHA treatment in the last 12 months.I have had long-term issues or current treatment for severe nasal or sinus conditions.I am a premenopausal woman planning a preventive breast removal or continued monitoring.I am generally healthy with normal lab results and physical exam.
- Group 1: Group 1 (planned risk reduction mastectomy)
- Group 2: Group 2 (continued survaillance)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
To whom is this trial open? Who meets the qualifications for enrollment in this experiment?
"The ideal participants for this trial are female, between 21 and 48 years old, and have a breast cancer diagnosis. So far, 11 people have been accepted into the study."
Does the FDA condone using laboratory biomarker analysis as a method?
"There is some data to support the safety of laboratory biomarker analysis, but none yet for efficacy. We rank it as a 2."
Are there any age restrictions for participants in this clinical trial?
"The age requirements for this clinical trial are that potential participants must be 21 years old or younger and 48 years old or younger."
Are there any open slots for new participants in this research project?
"At this moment, this clinical trial is not enrolling patients. Although, it was first posted 18 years ago on March 11th, 2004 and edited more recently on September 26th, 2022. There are presently 2698 trials actively admitting patients with breast cancer and 82 trials for laboratory biomarker analysis searching for participants."
How many individuals are being asked to participate in this research project?
"This study is not recruiting at this moment. The trial was first advertised on March 11th, 2004 and was last updated September 26th, 2022. However, there are presently 2698 trials actively enrolling participants with breast cancer and 82 studies for laboratory biomarker analysis actively enrolling participants."
What conditions can be diagnosed through laboratory biomarker analysis?
"hypogonadism, advanced androgen dependent prostate cancer, and amenorrhea can all be diagnosed and treated by laboratory biomarker analysis."
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