Goserelin Injections: Is Upper-Gluteal Dosing as Good as Abdominal Dosing for OFS in Localized and Locally Advanced HR+ Breast Cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 2 study comparing two administration sites for goserelin acetate to suppress ovarian function in premenopausal women with localized or locally advanced HR+ breast cancer. Participants must be 18 to under 50 years old, have confirmed HR+ disease (Stage I–III), and currently receive OFS with weekly or monthly goserelin in the abdomen with an aromatase inhibitor or tamoxifen, with plans to continue OFS for at least 12 months. The study uses biospecimen collection, goserelin injections, and questionnaire administration to assess outcomes. The primary goal is to determine if upper-gluteal injections are as effective as abdominal injections for maintaining OFS while the patient continues standard endocrine therapy.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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 running

• Mayo Clinic in Rochester
  Rochester, Minnesota, United States Recruiting

Study contacts

• Principal investigator: Karthik V. Giridhar, MD — Mayo Clinic
• Study coordinator: Clinical Trials Referral Office
• Email: mayocliniccancerstudies@mayo.edu
• Phone: 855-776-0015

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.