Status:
RECRUITING
Leuprolide and Goserelin for Ovarian Function Suppression in Pre- or Peri-menopausal Women With Breast Cancer, OFS Trial
Lead Sponsor:
University of Michigan Rogel Cancer Center
Conditions:
Anatomic Stage I Breast Cancer AJCC v8
Anatomic Stage II Breast Cancer AJCC v8
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
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...
Eligibility Criteria
Inclusion
- Female subject aged ≥ 18 years
- Pre- or peri-menopausal patient, who had (1) menses within the 12 months prior to enrollment or (2) estradiol concentration above the postmenopausal range per institutional laboratory guidance within the 12 months prior to enrollment
- Planning to take GnRHa therapy in combination with oral endocrine therapy (tamoxifen, anastrozole, exemestane, or letrozole) for adjuvant treatment of stage 1-3 breast cancer or for treatment of metastatic breast cancer
- Not planning bilateral salpingo-oophorectomy during the 6-month study duration
- Completion of chemotherapy, if given. Concurrent use of trastuzumab, pertuzumab, bisphosphonate therapy, poly adenosine diphosphate-ribose polymerase (PARP) inhibitor therapy, cyclin D kinase 4/6 (CDK4/6) inhibitor, and/or phosphoinositide 3-kinase (PI3K) inhibitor therapy is permitted
- Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines
Exclusion
- Prior bilateral salpingo-oophorectomy
- Known to be pregnant or breastfeeding (negative pregnancy test will be confirmed prior to study treatment initiation)
- Concomitant use of systemic or transdermal estrogen products
- Known allergy or hypersensitivity to goserelin or leuprolide, or any of the excipients in the medications
- Unable to take oral medications
- Any medical condition that would interfere with the absorption of endocrine therapy. Prior gastric bypass is permitted
- Patients with a prior or concurrent malignancy whose natural history or treatment, in the opinion of the treating investigator, has the potential to interfere with the safety or efficacy assessment of the investigational regimen
Key Trial Info
Start Date :
January 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2028
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT07158021
Start Date
January 1 2026
End Date
January 1 2028
Last Update
December 17 2025
Active Locations (1)
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1
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48109