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

NCT07158021 · University of Michigan Rogel Cancer Center
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Official title
Phase 2 Interventional Trial of Ovarian Function Suppression for Breast Cancer (OFS)
About this study
13MAY2026- New Amendment approved which made the following changes: * Study title updated reflect updated trial design * Arms updated to reflect study drug dosing assignments * Eligibility Criteria
Eligibility criteria
Inclusion Criteria: * 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 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
Study design
Enrollment target: 75 participants
Allocation: non_randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2026-01-22
Estimated completion: 2028-01-01
Last updated: 2026-06-23
Interventions
Procedure: Biospecimen CollectionOther: Electronic Health Record ReviewDrug: GoserelinDrug: LeuprolideOther: Questionnaire Administration
Primary outcomes
  • Proportion of participants with ultrasensitive estradiol concentration > 10 pg/ml (During the first 24 weeks of therapy)
Sponsor
University of Michigan Rogel Cancer Center · other
Contacts & investigators
ContactCancer AnswerLine · contact · CancerAnswerLine@med.umich.edu · 1-800-865-1125
InvestigatorNorah L Henry · principal_investigator, University of Michigan Rogel Cancer Center
All locations (1)
University of Michigan Comprehensive Cancer CenterRecruiting
Ann Arbor, Michigan, United States
Leuprolide and Goserelin for Ovarian Function Suppression in Pre- or Peri-menopausal Women With Breast Cancer, OFS Trial · TrialPath