Evaluation of Alternative Site Goserelin Acetate Injection for Ovarian Function Suppression (OFS) in Local and Locally Advanced Premenopausal Hormone Receptor Positive Breast Cancer Patients

StatusRecruiting
PhasePhase 2
Started

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Trial flagged as At Risk
Primary completion moved at least 2 months later Sep 26, 2028 → Dec 21, 2028
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Record History

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  1. Primary completion pushed from Sep 26, 2028 to Dec 21, 2028
    • Study completion moved earlier from Sep 26, 2029 to Jun 21, 2029
    • Eligibility criteria expanded, about 15 words
    • Secondary endpoints: details revised at 1 of 2 entries
  2. Recruitment opened
    • Start date changed from estimate of Mar 24, 2026 to May 22, 2026
    • Site details revised
    v2
  3. Study First Submitted
  • 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.
Mayo Clinic
1,024 trials monitored
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Breast Cancer
5,455 trials monitored
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This phase II trial determines if giving goserelin acetate injections in the upper gluteal region is as effective for ovarian function suppression (OFS) as giving injections in the abdomen for ovarian function suppression (OFS) in premenopausal patients with hormone receptor positive breast cancer that has not spread to other parts of the body (localized) or that has spread to nearby tissue or lymph nodes (locally advanced). Goserelin acetate is a drug used to treat prostate cancer, relieve the symptoms of advanced breast cancer, and treat problems with the endometrium (lining of the uterus). Goserelin acetate initially causes the pituitary gland to make more luteinizing hormone (LH) and follicle-stimulating hormone (FSH), temporarily increasing testosterone levels in men and estrogen levels in women. With continued use, goserelin acetate lowers the amount of LH and FSH the pituitary gland releases, leading to a drop in testosterone levels in men and estrogen levels in women. Goserelin acetate may stop the growth of cancer cells that need testosterone or estrogen to grow. It is a type of hormone therapy called a luteinizing hormone-releasing hormone (LHRH) agonist. Giving goserelin acetate injections in the upper gluteal region may be as effective for OFS as giving injections in the abdomen for OFS in premenopausal patients with localized or locally advanced hormone receptor positive breast cancer.
Trial Details
NCT Number NCT07460752
Lead Sponsor Mayo Clinic
Conditions
(from sponsor)		 Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8, Locally Advanced Hormone Receptor-Positive Breast Carcinoma
Enrollment 98 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov