Recruiting
Phase 2

Leuprolide vs. Goserelin

Sponsor:

University of Michigan Rogel Cancer Center

Code:

NCT07158021

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

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Biospecimen Collection

Electronic Health Record Review

Goserelin

Leuprolide

Questionnaire Administration

Study Details

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

Study ID

NCT07158021

Start date

Jan 22, 2026

Status verified date

Feb, 2026

Completion date

Jan 1, 2028

Anticipated

Primary completion date

Jan 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

75 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Arm I (leuprolide)

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.

experimental: Arm II (leuprolide)

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.

experimental: Arm III (goserelin)

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.

Interventions

Biospecimen Collection

Undergo blood sample collection

Electronic Health Record Review

Ancillary studies

Goserelin

Given SC

Leuprolide

Given IM

Questionnaire Administration

Ancillary studies

Primary outcome measure

  • Proportion of participants with ultrasensitive estradiol concentration > 10 pg/ml [ Time Frame: During the first 24 weeks of therapy ]

Central Contacts and Locations

Central contacts

Cancer AnswerLine

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

Locations

University of Michigan Comprehensive Cancer Center

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

Cancer AnswerLine

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

Principal Investigator:

Norah L. Henry

More Information

Sponsor

University of Michigan Rogel Cancer Center

Last update posted

Jun 23, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Michigan Rogel Cancer Center on 2026-06-23.