Leuprolide and Goserelin for Ovarian Function Suppression in Pre- or Peri-menopausal Women With Breast Cancer, OFS Trial

Recruiting now · Phase 2

Conditions studied: Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8, Metastatic Breast Carcinoma

In brief

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.

Key facts

Study ID

NCT07158021

Run by

University of Michigan Rogel Cancer Center

People needed

75

Starts

2026-01-22

Expected to finish

2028-01-01

Last updated by the study team

2026-06-23

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Female subject aged ≥ 18 years
• Pre- or peri-menopausal patient, who had (1) menses either within the 12 months prior to or since breast cancer diagnosis or (2) estradiol concentration above the postmenopausal range per institutional laboratory guidance either within the 12 months prior to or since breast cancer diagnosis.
• 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. Prior treatment with GnRHa therapy for treatment of non-oncologic conditions or during chemotherapy is permitted.
• 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

You may not qualify if…

• 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

Where it is running

• University of Michigan Comprehensive Cancer Center — Ann Arbor, Michigan, United States (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.