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RecruitingInterventionalPhase 2

Phase 2 Randomized Trial to Examine Ovarian Function Suppression for Breast Cancer (OFS)

NCT ID: NCT07158021Sponsor: University of Michigan Rogel Cancer CenterLast updated: 2026-02-13

Summary

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.

Arms & interventions

  • ProcedureBiospecimen Collection

    Undergo blood sample collection

  • OtherElectronic Health Record Review

    Ancillary studies

  • DrugGoserelin

    Given SC

  • DrugLeuprolide

    Given IM

  • OtherQuestionnaire Administration

    Ancillary studies

Outcome measures

Primary

  • Proportion of participants with ultrasensitive estradiol concentration > 10 pg/ml

    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.

    Time frame: During the first 24 weeks of therapy

Secondary

  • 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

Sex: FemaleAge: 18 Years and olderHealthy volunteers: No
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

Study locations (1)

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109

Recruiting
Cancer AnswerLine · Contact
Norah L. Henry · Principal Investigator