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

What Was Tested

In this phase 2 trial, researchers set out to test Goserelin.

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).

It had two arms (groups): Arm I (Goserelin acetate) (experimental) and 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 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo blood sample collection on study.

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.

The registry classes the interventions as drug, other and procedure.

Who Took Part

Enrollment: 98 planned participants were the target.

It was open to women only aged from 18 years up to 50 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: REGISTRATION (STEP 1): Age ≥ 18 years and ˂ 50 years. 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.

The full record lists 12 inclusion and 3 exclusion criteria; among the exclusions: 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.

How the Study Was Run

Design: randomized, parallel-group and open-label.

The participants were allocated by chance, so the Goserelin group and the comparison group should start out alike.

The Goserelin group and the comparison group ran side by side rather than switching.

Being open-label, the Goserelin study did not mask who received what.

It started in 2026-05-22 with completion listed for 2028-12-21.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Ovarian function suppression (OFS) maintenance (time frame: 6 months).

It also tracked 2 secondary outcomes, for example Provider-reported adverse events (AEs) and Injection site preference.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Goserelin in 98 people.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Goserelin compound page, all human trials.