A Trial to Evaluate Ovarian Suppression Following Subcutaneous ZOLADEX [amount hidden] in Premenopausal Women With Early-stage and Advanced HR+ Breast Cancer

What Was Tested

In this phase 1 trial, researchers set out to test Goserelin.

It had 1 arm (groups): one (experimental).

The registry classes the interventions as drug.

More on the Plan

Ovarian suppression will be evaluated by measuring LH levels over the treatment period.

Who Took Part

The registry lists 176 planned participants were the target.

It was open to women only aged from 18 years up to 55 years.

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

Examples of who could join: Age and gender: Female participants aged 18 to 55 years, inclusive. Participants must be of premenopausal status. Prior radiotherapy is allowed. All radiotherapy-related toxicities (except alopecia) must have recovered to Common Terminology Criteria for Adverse Events (CTCAE) v6.0 Grade ≤1 before trial enrollment. Cyclin-dependent kinase 4 (CDK4/6) inhibitors are permitted.

The full record lists 39 inclusion and 32 exclusion criteria; among the exclusions: postmenopausal: naturally or surgically postmenopausal (regardless of age); body mass index (bmi): \<18 kg/m\^2 or \>35.0 kg/m\^2; prior surgical or radiation procedures: history of bilateral oophorectomy or prior radiotherapy to the ovaries.

How the Study Was Run

Design: single-group and open-label.

Nothing was hidden in this open-label Goserelin study: the participants and staff both knew the treatment.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2026-10-30 with completion listed for 2027-03-30.

It ran at 26 sites in United States (26).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Percentage of Participants with LH Values Below a Specified Threshold at Week 6 Within Each Cohort (time frame: Week 6).

It also tracked 3 secondary outcomes, for example Percentage of Participants with LH Values below a Specified Threshold at Weeks 12, 18, and 24 Within Each Cohort, Percentage of Participants with Estradiol (E2) Suppression at Weeks 6, 12, 18, and 24 Within Each Cohort and Percentage of Participants with Absence of Menses at Weeks 6, 12, 18, and 24 Within Each Cohort.

What This Means in Plain Language

Put simply, this is a phase 1 trial of Goserelin in 176 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.