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

NCT07158021 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2026-02-13

No results posted yet for this study

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

Interventions

PROCEDURE

Biospecimen Collection

Undergo blood sample collection

OTHER

Electronic Health Record Review

Ancillary studies

DRUG

Goserelin

Given SC

DRUG

Leuprolide

Given IM

OTHER

Questionnaire Administration

Ancillary studies

Sponsors & Collaborators

  • University of Michigan Rogel Cancer Center

    lead OTHER

Principal Investigators

  • Norah L Henry · University of Michigan Rogel Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-22
Primary Completion
2028-01-01
Completion
2028-01-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07158021 on ClinicalTrials.gov