Study on Alternative Injection Sites for Goserelin Acetate in Premenopausal Breast Cancer Patients

Sponsor: Mayo Clinic

Sponsor score: 60

ClinicalTrials ID:NCT07460752

Provider View

This clinical trial is exploring whether giving goserelin acetate injections in the upper buttock area is as effective as giving them in the abdomen for suppressing ovarian function in premenopausal women with hormone receptor positive breast cancer that is localized or locally advanced.

Patient Parameters

Program Overview

This study aims to find out if injecting goserelin acetate in the upper buttock area works as well as injecting it in the abdomen for stopping ovarian function in premenopausal women with hormone receptor positive breast cancer that hasn't spread far. Goserelin acetate is a hormone therapy used to treat certain cancers by lowering hormone levels in the body. This trial will help determine if the alternative injection site is just as effective for patients who are already receiving this treatment.

Eligibility Criteria

Inclusion Criteria

  • Women aged 18 to under 50 years old.
  • Diagnosed with localized or locally advanced hormone receptor positive breast cancer (stage I-III) and have completed treatment aimed at curing the cancer.
  • Currently receiving monthly goserelin injections in the abdomen along with either an aromatase inhibitor or tamoxifen for at least 6 months, with plans to continue for at least another year.
  • In good general health with an ECOG performance status of 0, 1, or 2.
  • Able to provide written consent and complete questionnaires, with or without help.
  • Willing to provide blood samples for research purposes.
  • Agree to return for follow-up visits during the study.
  • Negative pregnancy tests before starting the study and before randomization.
  • Agree to use effective birth control methods during the study and for 3 months after the last dose.
  • Completed 6 cycles of ovarian function suppression with goserelin, with specific hormone levels achieved.

Exclusion Criteria

  • Received chemotherapy within 6 months before joining the study. However, ongoing treatment with certain other cancer therapies is allowed.
  • Taking any medications containing estrogen or progestin, including topical forms.
  • Planning to stop ovarian function suppression treatment in the next 12 months.

Locations

FACILITYZIPCITYSTATE
Mayo Clinic in Rochester55905RochesterMinnesota

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