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

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 i

Trial Details

NCT ID
NCT07158021
Phase
PHASE2
Sponsor
University of Michigan Rogel Cancer Center
Status
RECRUITING
Cancer Type
Breast Cancer
Interventions
  • Biospecimen Collection
  • Electronic Health Record Review
  • Goserelin
  • Leuprolide
  • Questionnaire Administration
Locations (sample)
  • Ann Arbor, Michigan, United States|42.27756,-83.74088

Key Eligibility 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 concentr…
  • Planning to take GnRHa therapy in combination with oral endocrine therapy (tamoxifen, anastrozole, exemestane, or letrozole) for adjuvant treatment…
  • Not planning bilateral salpingo-oophorectomy during the 6-month study duration

For full eligibility, visit ClinicalTrials.gov.

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