Leuprolide and Goserelin for Ovarian Function Suppression in Pre- or Peri-menopausal Women With Breast Cancer, OFS Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Biospecimen Collection, Electronic Health Record Review, Goserelin, Leuprolide.
- Who it may be relevant to
- Registry conditions: 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. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Phase 2 Interventional Trial of Ovarian Function Suppression for Breast Cancer (OFS)
Overview
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.
Detailed description
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
Interventions
- Procedure Biospecimen Collection
Undergo blood sample collection - Other Electronic Health Record Review
Ancillary studies - Drug Goserelin
Given SC - Drug Leuprolide
Given IM - Other Questionnaire Administration
Ancillary studies
Primary outcome measures
- Proportion of participants with ultrasensitive estradiol concentration > 10 pg/ml [Time frame: During the first 24 weeks of therapy]
Secondary outcome measures (8)
- Proportion of participants with ultrasensitive estradiol concentration > 10 pg/ml [Time frame: At 4 weeks after initial GnRHa treatment administration]
- Proportion of participants with ultrasensitive estradiol concentration > 10 pg/ml [Time frame: Any time after 4 weeks of initial GnRHa treatment administration, assessed cycle 3 day 1-cycle 7 day 1 (cycle length = 28 days)]
- Change in Functional Assessment of Cancer Therapy-(FACT)-Endocrine Subscale (ES) Trial Outcome Index [Time frame: Up to 24 weeks]
- Change in FACT-ES Endocrine Symptom Subscale [Time frame: Up to 24 weeks]
- Percentage of participants reporting discomfort of 6/10 or higher on the Discomfort of Injection questionnaire [Time frame: At the day following initial GnRHa injection]
- Percentage of participants reporting discomfort of 6/10 or higher on the Discomfort of Injection questionnaire [Time frame: Before administration of the second GnRHa injection]
- Receipt of GnRHa therapy within ± 1 day of planned dosing [Time frame: Up to 24 weeks]
- Incidence of adverse events (AEs) [Time frame: Up to 24 weeks]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- University of Michigan Comprehensive Cancer Center — Ann Arbor
Identifiers
NCT: NCT07158021 · UMCC 2025.016 · NCI-2025-03933 · HUM00270281