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

NCT07158021 | Recruiting Phase 2 DMC FDA Drug

• 3 other identifiers: UMCC 2025.016NCI-2025-03933HUM00270281
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief 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.

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

Outcome Measures

Primary Outcomes (1)

• 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.

  During the first 24 weeks of therapy

Secondary Outcomes (8)

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

  At 4 weeks after initial GnRHa treatment administration

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

  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

  Up to 24 weeks

• Change in FACT-ES Endocrine Symptom Subscale

  Up to 24 weeks

• Percentage of participants reporting discomfort of 6/10 or higher on the Discomfort of Injection questionnaire

  At the day following initial GnRHa injection

Study Arms (3)

Arm I (leuprolide)

EXPERIMENTAL

Leuprolide 3.75 mg q4weeks. 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.

Procedure: Biospecimen Collection; Other: Electronic Health Record Review; Drug: Leuprolide; Other: Questionnaire Administration

Arm II (leuprolide)

EXPERIMENTAL

Leuprolide 7.5 mg q4weeks. 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.

Procedure: Biospecimen Collection; Other: Electronic Health Record Review; Drug: Leuprolide; Other: Questionnaire Administration

Arm III (goserelin)

EXPERIMENTAL

Goserelin 3.6 mg q4 weeks. 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.

Procedure: Biospecimen Collection; Other: Electronic Health Record Review; Drug: Goserelin; Other: Questionnaire Administration

Interventions

Biospecimen Collection PROCEDURE

Undergo blood sample collection

Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection

Arm I (leuprolide); Arm II (leuprolide); Arm III (goserelin)

Electronic Health Record Review OTHER

Ancillary studies

Arm I (leuprolide); Arm II (leuprolide); Arm III (goserelin)

Goserelin DRUG

Given SC

Also known as: ICI-118630

Arm III (goserelin)

Leuprolide DRUG

Given IM

Also known as: Leuprorelin

Arm I (leuprolide); Arm II (leuprolide)

Questionnaire Administration OTHER

Ancillary studies

Arm I (leuprolide); Arm II (leuprolide); Arm III (goserelin)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Michigan Rogel Cancer Center: lead

Study Sites (1)

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109, United States

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Specimen Handling; Goserelin; Leuprolide

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Study Officials

• Norah L Henry

  University of Michigan Rogel Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cancer AnswerLine

CONTACT

1-800-865-1125; CancerAnswerLine@med.umich.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2025
• First Posted: September 5, 2025
• Study Start: January 22, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2028
• Last Updated: June 23, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: researchers can request data once the primary analysis has been published
• Access Criteria: deidentified data will be available to researchers upon reasonable request

Locations

US (1)