RecruitingPhase 2NCT07158021

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

Phase 2 Randomized Trial to Examine Ovarian Function Suppression for Breast Cancer (OFS)

Sponsor

University of Michigan Rogel Cancer Center

Enrollment

75 participants

Start Date

Jan 22, 2026

Study Type

INTERVENTIONAL

Conditions

Anatomic Stage II Breast Cancer AJCC v8 Anatomic Stage III Breast Cancer AJCC v8 Anatomic Stage IV Breast Cancer AJCC v8 Metastatic Breast Carcinoma Anatomic Stage I Breast Cancer AJCC v8

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 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.

Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial compares two different hormone-suppressing injections — leuprolide and goserelin — for pre- and peri-menopausal women with hormone receptor-positive breast cancer. Both are used to shut down ovarian function as part of breast cancer treatment, and the study is looking at whether they are equally effective. **You may be eligible if...** - You are a woman aged 18 or older - You are pre- or peri-menopausal (still having periods or recently menopausal) - You have Stage 1–3 breast cancer or metastatic breast cancer that requires hormone-blocking therapy - You are planning to take one of these injections alongside an oral hormone-blocking pill **You may NOT be eligible if...** - You have already had both ovaries surgically removed - You are pregnant or breastfeeding - You are using estrogen products (patches, pills, or creams) - You have a known allergy to goserelin or leuprolide Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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