Evaluation of Alternative Site Goserelin Acetate Injection for Ovarian Function Suppression (OFS) in Local and Locally Advanced Premenopausal Hormone Receptor Positive Breast Cancer Patients
Eligible age
18–50 yrs
Accepts
Women
Locations
1 state
Healthy volunteers
No
See if you qualify for this study
Answer a few quick questions about your location and health. Takes about a minute.
About this study
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.
Sponsor: Mayo Clinic
You may qualify if…
- ✓ REGISTRATION (STEP 1): Age ≥ 18 years and ˂ 50 years
- ✓ REGISTRATION (STEP 1): Have histologically or cytologically confirmed, localized or locally advanced hormone positive breast cancer stage I-III (defined as ER Immunohistochemistry (IHC) \> 1%\] having completed curative intent therapy and clinically in remission
- ✓ REGISTRATION (STEP 1): Currently receiving ovarian function suppression (OFS) with use of goserelin on a monthly basis in the abdomen and either aromatase inhibitor or tamoxifen for at least 6 months prior to study enrollment for treatment of hormone receptor positive breast cancer with plan to continue medical OFS for at least the next 12 months
- ✓ REGISTRATION (STEP 1): Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2
- ✓ REGISTRATION (STEP 1): Provide written informed consent
- ✓ REGISTRATION (STEP 1): Ability to complete questionnaire(s) by themselves or with assistance
- ✓ REGISTRATION (STEP 1): Willingness to provide mandatory blood specimens for correlative research
- ✓ REGISTRATION (STEP 1): Willing to return to enrolling institution for follow-up (during the active monitoring phase of the study)
You may not qualify if…
- ✕ REGISTRATION (STEP 1): Any of the following prior therapies: Chemotherapy =\< 6 months prior to registration. NOTE: concurrent receipt of human epidermal growth factor receptor 2 (HER2) directed antibodies or antibody-drug conjugates, endocrine therapy, or cyclin-dependent kinase (CDK) 4/6 inhibitor is permitted
- ✕ REGISTRATION (STEP 1): Receiving any estrogen or progestin containing medications, including topical estrogens
- ✕ REGISTRATION (STEP 1): Planning to temporarily or permanently discontinue medical OFS in the next 12 months
Where it's recruiting
Rochester
Source: ClinicalTrials.gov · NCT07460752 · last updated 2026-07-08