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Leuprolide and Goserelin for Ovarian Function Suppression in Breast Cancer

This study is comparing two medications, leuprolide and goserelin, to see which is better at reducing estrogen (a hormone that can make breast cancer grow) in pre- or peri-menopausal women with breast cancer. Both leuprolide and goserelin work by suppressing the ovaries, which produce estrogen. The study will look at different doses of leuprolide against goserelin to see how well they lower estrogen levels. The goal is to find out if leuprolide is as safe and effective as goserelin in stopping the ovaries from making estrogen. You may be eligible if you are a woman aged 18 or older, and are pre- or peri-menopausal with breast cancer (stages I-IV). The main goal is to see what proportion of participants have an ultrasensitive estradiol (estrogen) concentration above a certain level during the first 24 weeks of therapy.

Study design
This is an interventional study with a planned enrollment of 75 participants. It compares lower dose leuprolide, higher dose leuprolide, and goserelin.
What's involved
Participants will have blood samples collected and may complete questionnaires. Goserelin is given under the skin (SC) and leuprolide is given into the muscle (IM).
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint is measured during the first 24 weeks of therapy.

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NCT07158021

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

Recruiting
PHASE2Ages 18+InterventionalTreatment
University of Michigan Rogel Cancer Center
~75 participants
Updated 2026-06-23 on ClinicalTrials.gov
What's tested:Biospecimen CollectionElectronic Health Record ReviewGoserelinLeuprolideQuestionnaire Administration

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Proportion of participants with ultrasensitive estradiol concentration > 10 pg/ml
Measured over During the first 24 weeks of therapy

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
Metastatic Breast Carcinoma

Explore related trials

Breast Carcinoma

Where it's being run

1 sites across 1 states
Michigan1

Study leadership

  • Norah L Henry · PRINCIPAL_INVESTIGATOR · University of Michigan Rogel Cancer Center

Who to contact

Cancer AnswerLine
[email protected]
1-800-865-1125
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Proportion of participants with ultrasensitive estradiol concentration > 10 pg/mlDuring the first 24 weeks of therapy

    Analyses will primarily be descriptive reporting the overall and by treatment group proportions of women with ultrasensitive estradiol concentration and the corresponding exact binomial 95% confidence intervals over the first 24 weeks of gonadotropin releasing hormone agonist (GnRHa) therapy.