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

  • PhasePhase 2
  • StatusRecruiting
  • Planned enrollment98 people
  • Recruiting US sites1
  • SponsorMayo Clinic
  • RegistryNCT07460752

Recruitment re-checked on ClinicalTrials.gov Oct 30, 2026. Public record; not medical advice.

Evaluation of Alternative Site Goserelin Acetate Injection for Ovarian Function Suppression (OFS) in Local and Locally Advanced Premenopausal Hormone Receptor Positive Breast Cancer Patients: a one-minute explainerNCT074607521 min

Eligibility

Who can join

The film gives the main points. The full list below is copied from the registry; the study team makes the final decision.

  • Age18 Years to 50 Years
  • SexFemale
  • Healthy volunteersNo

You may be able to join 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)
  • REGISTRATION (STEP 1): Negative serum pregnancy test =< 14 days prior to registration, and a negative urine pregnancy test =< 7 days prior to randomization
  • REGISTRATION (STEP 1): Sexually active patients and their partners must use an effective method of contraception associated with a low failure rate prior to study entry and for the duration of study participation and for at least 3 months after the last dose of study drug.
  • Note: The following are considered effective contraceptives: oral contraceptive pill; condom plus spermicide; diaphragm plus spermicide; patient or partner surgically sterile; patient or partner more than 12 months postmenopausal; or injectable or implantable agent/device. Male patients should refrain from sperm donation and female patients should refrain from breastfeeding throughout this period
  • RANDOMIZATION (STEP 2): Completion of the lead-in treatment of 6 cycles of ovarian function suppression (OFS) with use of goserelin, with estradiol E2 value of ˂ 20 pg/mL and no back to back E2 levels > 10 pg/mL after cycle 6 blood draw

You cannot join 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

The treatment

How it is intended to work

This is how the treatment is meant to work. Whether it helps, and how safe it is, is what this trial is testing.

Treatments listed in the registry

  • Biospecimen Collection (Procedure): Undergo blood sample collection
  • Goserelin Acetate (Drug): Given SC
  • Questionnaire Administration (Other): Ancillary studies

The study

Treatment groups

Randomized · Parallel · masking: None

Arm I (Goserelin acetate) (Experimental)

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.

Arm II (Goserelin acetate) (Experimental)

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.

What it involves

Procedures

As the registry describes them. Requirements to join, such as a tissue sample, are in the eligibility list above even when on-study procedures are optional. Ask the study team which steps apply to you.

  • blood samples: Part of the study plan
  • questionnaires: Part of the study plan

Goals

What the study measures

Main goals

  • Ovarian function suppression (OFS) maintenance (6 months)

Other goals

  • Provider-reported adverse events (AEs)
  • Injection site preference

Planned enrollment: 98 (estimated).

Where

Recruiting US sites

  • Mayo Clinic in Rochester, Rochester, Minnesota

Site status as of Oct 30, 2026. Check the live record before contacting a site.

Sources

Where this comes from

Registry record reviewed as fetched Oct 30, 2026, last updated by the sponsor Sep 30, 2026. Public record; not medical advice.

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