MC250301, OptiOFS: A Randomized Phase II Trial of Alternative Site Goserelin Acetate Injection for Ovarian Function Suppression (OFS) in Local and Locally Advanced Premenopausal Breast Cancer

Summary

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.

Eligibility

Age range

18–50 years

Sex

Female

Healthy volunteers

No

Interventions

• Procedure
  Biospecimen Collection

  Undergo blood sample collection

• Drug
  Goserelin Acetate

  Given SC

• Other
  Questionnaire Administration

  Ancillary studies

Location