Phase 1 Open-label Study of Subcutaneous ZOLADEX 10.8 mg for Ovarian Suppression in Premenopausal Women With Hormone Receptor Positive, HER2 Negative Advanced Breast Cancer

What this Trial Is About

Researchers are evaluating ovarian suppression in premenopausal women with hormone receptor-positive HR, HER2-negative advanced breast cancer. The study aims to assess how well ZOLADEX 10.8 mg suppresses ovarian function by measuring luteinizing hormone LH levels during treatment. This Phase 1, single-arm, open-label trial seeks to understand the degree and consistency of ovarian suppression in this patient group. Participants will receive two doses of ZOLADEX 10.8 mg as subcutaneous injections one on Day 1 Week 1 and another on Day 85 Week 12. The study focuses on tracking ovarian suppression by measuring hormone levels over the treatment period, with no placebo or comparison group involved. During the study, participants will have their LH levels measured at various time points, including Week 6 as the primary outcome and Weeks 12, 18, and 24 for secondary outcomes. Other assessments include estradiol suppression and absence of menses at these same intervals. Participants will be monitored for safety and treatment effects throughout the study which may last up to 24 weeks after treatment initiation.

A Trial to Evaluate Ovarian Suppression Following Subcutaneous ZOLADEX 10.8 mg in Premenopausal Women With HR+, HER2- Advanced Breast Cancer