Leuprolide and Goserelin for Ovarian Function Suppression in Pre- or Peri-menopausal Women With Breast Cancer, OFS Trial
NCT ID: NCT07158021
Last Updated: 2025-11-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
75 participants
INTERVENTIONAL
2025-12-01
2027-12-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm I (leuprolide)
Patients receive lower dose leuprolide IM on day 1 of each cycle. Cycles repeat every 28 days for up to 24 weeks in the absence of disease progression or unacceptable toxicity. Patients also undergo blood sample collection throughout the study.
Biospecimen Collection
Undergo blood sample collection
Electronic Health Record Review
Ancillary studies
Leuprolide
Given IM
Questionnaire Administration
Ancillary studies
Arm II (leuprolide)
Patients receive higher dose leuprolide IM on day 1 of each cycle. Cycles repeat every 28 days for up to 24 weeks in the absence of disease progression or unacceptable toxicity. Patients also undergo blood sample collection throughout the study.
Biospecimen Collection
Undergo blood sample collection
Electronic Health Record Review
Ancillary studies
Leuprolide
Given IM
Questionnaire Administration
Ancillary studies
Arm III (goserelin)
Patients receive goserelin SC on day 1 of each cycle. Cycles repeat every 28 days for up to 24 weeks in the absence of disease progression or unacceptable toxicity. Patients also undergo blood sample collection throughout the study.
Biospecimen Collection
Undergo blood sample collection
Electronic Health Record Review
Ancillary studies
Goserelin
Given SC
Questionnaire Administration
Ancillary studies
Interventions
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Biospecimen Collection
Undergo blood sample collection
Electronic Health Record Review
Ancillary studies
Goserelin
Given SC
Leuprolide
Given IM
Questionnaire Administration
Ancillary studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Pregnant or breast feeding, or plan to become pregnant during the study period
* 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
18 Years
FEMALE
No
Sponsors
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University of Michigan Rogel Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Norah L Henry
Role: PRINCIPAL_INVESTIGATOR
University of Michigan Rogel Cancer Center
Locations
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University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States
Countries
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Central Contacts
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Facility Contacts
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Cancer AnswerLine
Role: primary
Other Identifiers
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NCI-2025-03933
Identifier Type: REGISTRY
Identifier Source: secondary_id
HUM00270281
Identifier Type: OTHER
Identifier Source: secondary_id
UMCC 2025.016
Identifier Type: -
Identifier Source: org_study_id