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

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Eligibility criteria expanded, about 25 words
    • Study description expanded, about 26 words
    v6
  2. Start date changed from estimate of Jan 1, 2026 to Jan 22, 2026v5
  3. Start date: Dec 1, 2025 to Jan 1, 2026
    • Primary and study completion dates: Dec 1, 2027 to Jan 1, 2028
    v4
  4. Eligibility criteria expanded, about 4 wordsv3
  5. Trial status: Not Yet Recruiting to Recruiting
    • Start date: Oct 1, 2025 to Dec 1, 2025
    • Primary and study completion dates: Oct 1, 2027 to Dec 1, 2027
    • Site details revised
    v2
  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07158021
Lead Sponsor University of Michigan Rogel Cancer Center
Conditions
(from sponsor)		 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
Related terms Breast Neoplasms
Enrollment 75 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov