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 suppresion (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.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT07460752.
Locations matching your search criteria
United States
Minnesota
Rochester
Mayo Clinic in RochesterStatus: Approved
Contact: Karthik Vikram Giridhar
Phone: 507-284-2511
PRIMARY OBJECTIVES:
I. To determine if monthly upper gluteal region administration of goserelin maintains ovarian function suppression (OFS) after switching from monthly abdominal administration of goserelin in pre-menopausal hormone positive breast cancer.
II. To determine if quarterly upper gluteal region administration of goserelin maintains ovarian function suppression (OFS) after switching from monthly abdominal administration of goserelin in pre-menopausal hormone positive
breast cancer.
SECONDARY OBJECTIVES:
I. To evaluate participant injection site preference (abdomen/upper gluteal region).
II. Rate of failure of OFS in patients receiving abdominal or upper gluteal region injections of goserelin.
III. To evaluate patient-reported adverse events and overall quality of life (QOL) as determined patient reported outcome survey based on administration site (upper gluteal region versus abdomen) over 6 months among premenopausal patients with hormone receptor positive (HR+) breast cancer receiving aromatase inhibitors (AI) therapy and subcutaneous goserelin for at least 6 months.
IV. To evaluate provider reported adverse events as determined by Common Terminology Criteria for Adverse Events (CTCAE) version (V) 5.0 on adverse event grading.
CORRELATIVE OBJECTIVES:
I. Estradiol (E2) suppression levels over 12 months.
II. Quality of life metrics.
OUTLINE:
Patients receive goserelin acetate subcutaneously (SC) in the abdomen on day 1 of each cycle. Cycles repeat every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients are then randomized to 1 of 2 arms.
ARM I: Patients receive goserelin acetate SC in the upper gluteal region on day 1 of each cycle. Cycles repeat every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo blood sample collection on study.
ARM II: Patients receive goserelin acetate SC in the upper gluteal region on day 1 of each cycle. Cycles repeat every 84 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo blood sample collection on study.
Lead OrganizationMayo Clinic in Rochester
Principal InvestigatorKarthik Vikram Giridhar
