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

What this trial studies

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.

Conditions in scope

• 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

Interventions

• Biospecimen Collection (Procedure) — Undergo blood sample collection
• Electronic Health Record Review (Other) — Ancillary studies
• Goserelin (Drug) — Given SC
• Leuprolide (Drug) — Given IM
• Questionnaire Administration (Other) — Ancillary studies

Who can join

Women only · Ages 18 Years and up

Inclusion criteria

• 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 criteria

• 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

Eligibility wording paraphrased from the public record. View the full criteria on ClinicalTrials.gov before contacting a site.

Where it’s happening

Status & timeline

• Overall status: Recruiting
• Study type: Interventional
• Phase: PHASE2
• Start date: 2026-01-22
• Primary completion: 2028-01-01
• Last update posted: 2026-02-13
• First posted: 2025-09-05

Sponsor & contact

Lead sponsor: University of Michigan Rogel Cancer Center (Other)

For trial site contact information, use the official record at ClinicalTrials.gov. Contact details change frequently and the public record is the source of truth.

Outcome measures

Primary outcomes

• Proportion of participants with ultrasensitive estradiol concentration > 10 pg/ml (During the first 24 weeks of therapy)
  Analyses will primarily be descriptive reporting the overall and by treatment group proportions of women with ultrasensitive estradiol concentration and the corresponding exact binomial 95% confidence intervals over the first 24 weeks of gonadotropin releasing hormone agonist (GnRHa) therapy.

Related ClearedRx care

If you’re reading this trial because you have menopause symptoms now, you don’t have to wait for a trial to access evidence-based care. ClearedRx prescribes the same FDA-approved and compounded HRT products that have been studied in trials like this one for decades.