Study on Leuprolide and Goserelin for Reducing Estrogen in Pre- or Peri-menopausal Women with Breast Cancer
Sponsor: University of Michigan Rogel Cancer Center
ClinicalTrials ID:NCT07158021
This clinical trial is comparing two medications, leuprolide and goserelin, to see how well they reduce estrogen production in pre- or peri-menopausal women with breast cancer. Lowering estrogen levels may help stop the growth of breast cancer cells that rely on this hormone.
Patient Parameters
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Program Overview
The purpose of this study is to compare the effectiveness of two drugs, leuprolide and goserelin, in reducing estrogen production by the ovaries in women who are pre- or peri-menopausal and have breast cancer. Estrogen can promote the growth of breast cancer cells, so reducing its production may help control the disease. The study will look at different doses of leuprolide and compare them to goserelin to see which is more effective and safe in suppressing ovarian function.
Eligibility Criteria
Inclusion Criteria
- Women aged 18 years or older.
- Pre- or peri-menopausal, meaning they have had a menstrual period in the last year or have hormone levels indicating they are not yet postmenopausal.
- Planning to use GnRHa therapy along with oral hormone therapy (such as tamoxifen or letrozole) for treating stage 1-3 breast cancer or metastatic breast cancer.
- Not planning to have surgery to remove ovaries during the 6-month study.
- Completed chemotherapy if it was part of their treatment plan. Other treatments like trastuzumab or bisphosphonates are allowed.
- Able to understand and sign a consent form agreeing to participate in the study.
Exclusion Criteria
- Have had surgery to remove both ovaries.
- Pregnant or breastfeeding (a negative pregnancy test is required before starting the study).
- Using estrogen products in any form.
- Allergic to goserelin or leuprolide, or any ingredients in these medications.
- Unable to take oral medications.
- Have a medical condition that affects how the body absorbs hormone therapy. Previous gastric bypass surgery is allowed.
- Have another cancer that could affect the study's results, according to the study doctor.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| University of Michigan Comprehensive Cancer Center | 48109 | Ann Arbor | Michigan |
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