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Study of Goserelin Acetate Injection Sites for Ovarian Function Suppression in Breast Cancer

This study is looking at whether giving goserelin acetate injections in the upper gluteal (buttock) area is as effective as giving them in the abdomen. This is for premenopausal women (ages 18-50) with hormone receptor-positive breast cancer that is localized (has not spread) or locally advanced (spread to nearby tissue or lymph nodes). Goserelin acetate helps suppress ovarian function (OFS), which is important in treating this type of breast cancer. The main goal is to see if ovarian function suppression is maintained for 6 months with the new injection site. The study plans to enroll 98 participants, but its current recruitment status is unclear.

Study design
This is a Phase II interventional study that plans to enroll 98 participants.
What's involved
You would have blood samples collected and receive goserelin acetate injections. You would also complete questionnaires for additional studies.
Compensation
Not stated in the trial record.
Follow-up
The study will measure ovarian function suppression at 6 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07460752

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

Recruiting
PHASE2Ages 18–50InterventionalTreatment
Mayo Clinic
~98 participants
Updated 2026-07-08 on ClinicalTrials.gov
What's tested:Biospecimen CollectionGoserelin AcetateQuestionnaire Administration

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Ovarian function suppression (OFS) maintenance
Measured over 6 months

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

Explore related trials

Breast Carcinoma

Where it's being run

1 sites across 1 states
Minnesota1

Study leadership

  • Karthik V. Giridhar, MD · PRINCIPAL_INVESTIGATOR · Mayo Clinic

Who to contact

Clinical Trials Referral Office
[email protected]
855-776-0015
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Ovarian function suppression (OFS) maintenance6 months

    Failure to maintain OFS (yes; no) is defined as estradiol ≥ 10 pg/mL on two separate occasions. Will be based on calculating the within-arm sample proportion of patients for whom upper gluteal region administration of goserelin for 6 months failed to maintain OFS after switching from monthly abdominal administration of goserelin and corresponding upper bound of the one-sided 97.5% confidence interval (CI). Provided that the upper bound of the one sided 97.5% CI excludes 10%, the primary aim for that arm will have been met.