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

Part of paid clinical trials in Rochester, Minnesota.

Sponsor
Mayo Clinic
Study ID
NCT07460752
Phase
PHASE2
Status
Recruiting
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Conditions

  • 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

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 50 Years
Healthy Volunteers
Not accepted

Interventions

  • Biospecimen Collection — PROCEDURE
    Undergo blood sample collection
  • Goserelin Acetate — DRUG
    Given SC
  • Questionnaire Administration — OTHER
    Ancillary studies

Study Details

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.

Key Dates

First listed
Mar 10, 2026
Start date
May 22, 2026
Status verified
Jul 2026
Primary completion
Sep 26, 2028
Completion
Sep 26, 2029

Study Design

Enrollment
98 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm I (Goserelin acetate)
    Patients receive goserelin acetate 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 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.
  • Experimental: Arm II (Goserelin acetate)
    Patients receive goserelin acetate 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 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.

Primary Outcome Measure

Ovarian function suppression (OFS) maintenance [ Time Frame: 6 months ]

Central Contacts

  • Clinical Trials Referral Office
    855-776-0015
    [email protected]
  • Cancer Center Clinical Trials
    507-293-6386

Locations (1)

FacilityCityStateZIPSite coordinators
Mayo Clinic in RochesterRochesterMinnesota55905
Clinical Trials Referral Office
[email protected]
855-776-0015
Cancer Center Clinical Trials
507-293-6386
Karthik V. Giridhar, MD (PRINCIPAL_INVESTIGATOR)

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