ZOLADEX for Ovarian Suppression in Advanced Breast Cancer
This study is testing ZOLADEX 10.8 mg in premenopausal women (ages 18-55) with advanced breast cancer that is hormone receptor positive (HR+) and HER2 negative (HER2-). The main goal is to see how well ZOLADEX suppresses ovarian function, which is measured by checking luteinizing hormone (LH) levels at Week 6. Participants will receive two subcutaneous (under the skin) injections of ZOLADEX, one at the start and another at Week 12. The study aims to enroll 88 participants to understand the consistency of ovarian suppression with this treatment.
- Study design
- This interventional study plans to enroll 88 women. The phase of the study is not specified.
- What's involved
- Participants will receive two ZOLADEX injections: one on Day 1 and another on Day 85. Ovarian suppression will be evaluated by measuring LH levels over the treatment period.
- Compensation
- Not stated in the trial record.
- Follow-up
- Ovarian suppression is measured at Week 6. The study involves treatments up to Week 12.
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A Trial to Evaluate Ovarian Suppression Following Subcutaneous ZOLADEX 10.8 mg in Premenopausal Women With Early-stage and Advanced HR+ Breast Cancer
At a glance
Conditions
Where it's being run
20 sites across 12 statesStudy leadership
- Christine Fredericks · STUDY_DIRECTOR · TerSera Therapeutics LLC
Who to contact
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What this trial measures
- Percentage of Participants with LH Values Below a Specified Threshold at Week 6 Within Each CohortWeek 6