Leuprolide versus goserelin to stop ovarian estrogen production in pre- or peri-menopausal women with breast cancer
Phase 2 Randomized Trial to Examine Ovarian Function Suppression for Breast Cancer (OFS)
This study tests whether two doses of leuprolide or goserelin better stops the ovaries from making estrogen in pre- or peri-menopausal women with breast cancer.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 75 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | University of Michigan Rogel Cancer Center Academic / other |
| Drugs / interventions | trastuzumab, pertuzumab, chemotherapy |
| Locations | 1 site (Ann Arbor, Michigan) |
| Trial ID | NCT07158021 on ClinicalTrials.gov |
What this trial studies
This is a phase II clinical comparison of two doses of leuprolide versus standard-dose goserelin for ovarian function suppression in pre- or peri-menopausal women with breast cancer. Participants receive one of the leuprolide doses or goserelin alongside oral endocrine therapy and are followed for six months. The study measures estrogen suppression using blood tests, collects biospecimens, reviews electronic health records, and uses questionnaires to track tolerability and safety. The goal is to determine whether lower or higher dose leuprolide provides comparable ovarian suppression and side-effect profile to goserelin.
Who should consider this trial
Good fit: Women aged 18 or older who are pre- or peri-menopausal with stage I–III adjuvant or metastatic breast cancer planning to receive GnRHa therapy plus oral endocrine therapy and who are not having bilateral salpingo-oophorectomy during the six-month study period are appropriate candidates.
Not a fit: Postmenopausal women, patients not planning GnRHa plus oral endocrine therapy, or those planning bilateral oophorectomy during the study period are unlikely to receive benefit from this protocol.
Why it matters
Potential benefit: If successful, the study could identify an effective ovarian suppression option with similar safety that might allow use of a lower leuprolide dose to reduce side effects or cost.
How similar studies have performed: GnRHa agents such as goserelin and leuprolide are well established to suppress ovarian function, but direct dose-comparison trials of leuprolide versus goserelin are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Ann Arbor, Michigan
- University of Michigan Comprehensive Cancer Center — Ann Arbor, Michigan, United States (Recruiting)
Study contacts
- Principal investigator: Norah L Henry — University of Michigan Rogel Cancer Center
- Study coordinator: Cancer AnswerLine
- Email: CancerAnswerLine@med.umich.edu
- Phone: 1-800-865-1125
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.