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

The film gives the main points. The full list below is copied from the registry; the study team makes the final decision.

• Age18 Years to no maximum
• SexFemale
• Healthy volunteersNo

You may be able to join 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 cannot join 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

This is how the treatment is meant to work. Whether it helps, and how safe it is, is what this trial is testing.

Treatments listed in the registry

• 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

Non Randomized · Parallel · masking: None

As the registry describes them. Requirements to join, such as a tissue sample, are in the eligibility list above even when on-study procedures are optional. Ask the study team which steps apply to you.

• blood samples: Part of the study plan
• questionnaires: Part of the study plan

Main goals

• Proportion of participants with ultrasensitive estradiol concentration > 10 pg/ml (During the first 24 weeks of therapy)

Other goals

• Proportion of participants with ultrasensitive estradiol concentration > 10 pg/ml
• Proportion of participants with ultrasensitive estradiol concentration > 10 pg/ml
• Change in Functional Assessment of Cancer Therapy-(FACT)-Endocrine Subscale (ES) Trial Outcome Index
• Change in FACT-ES Endocrine Symptom Subscale
• Percentage of participants reporting discomfort of 6/10 or higher on the Discomfort of Injection questionnaire
• Percentage of participants reporting discomfort of 6/10 or higher on the Discomfort of Injection questionnaire
• Receipt of GnRHa therapy within ± 1 day of planned dosing
• Incidence of adverse events (AEs)

Planned enrollment: 75 (estimated).

• University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan

Site status as of Oct 30, 2026. Check the live record before contacting a site.

• ClinicalTrials.gov NCT07158021

Registry record reviewed as fetched Oct 30, 2026, last updated by the sponsor Jun 22, 2026. Public record; not medical advice.