drugset / Trial / NCT07158021

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

NCT07158021

Phase 2 Recruiting 75 enrolled University of Michigan Rogel Cancer Center
Non-randomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2026-01-22
Primary completion
2028-01-01
Completion
2028-01-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Goserelin Other / unclassified 3.6 mg Subcutaneous
Subject Leuprolide Other / unclassified 3.75 mg Intramuscular
Subject Leuprolide Other / unclassified 7.5 mg Intramuscular