Actively Recruiting
Leuprolide and Goserelin for Ovarian Function Suppression in Pre- or Peri-menopausal Women With Breast Cancer, OFS Trial
Led by University of Michigan Rogel Cancer Center · Updated on 2026-02-13
75
Participants Needed
1
Research Sites
101 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This phase II trial compares leuprolide to goserelin for reducing estrogen production by the ovaries in pre- or peri-menopausal women with breast cancer. Estrogen can cause the growth of breast cancer cells. Both leuprolide and goserelin lower the amount of estrogen made by the body. This may help stop the growth of tumor cells that need estrogen to grow. This study compares lower dose leuprolide, higher dose leuprolide, and goserelin for their ability to suppress the function of the ovaries to produce estrogen. Both doses of leuprolide may be as safe, tolerable and/or effective as goserelin in suppressing ovarian function in pre- or peri-menopausal women with breast cancer.
CONDITIONS
Official Title
Leuprolide and Goserelin for Ovarian Function Suppression in Pre- or Peri-menopausal Women With Breast Cancer, OFS Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female aged 18 years or older
- Pre- or peri-menopausal with menses in the last 12 months or estradiol above postmenopausal range in past 12 months
- Planning to use GnRHa therapy plus oral endocrine therapy for stage 1-3 or metastatic breast cancer
- Not planning bilateral salpingo-oophorectomy during the 6-month study
- Completed chemotherapy if given; concurrent use of certain therapies allowed
- Able and willing to provide informed consent
You will not qualify if you...
- Prior bilateral salpingo-oophorectomy
- Pregnant or breastfeeding
- Using systemic or transdermal estrogen products
- Allergic to goserelin, leuprolide, or their components
- Unable to take oral medications
- Any medical condition interfering with endocrine therapy absorption (except prior gastric bypass)
- Prior or concurrent malignancy that could affect safety or efficacy assessment
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
Research Team
C
Cancer AnswerLine
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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