NCT07310420

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

Phase 1 Single-arm, Open-label, Multicenter Trial to Evaluate Ovarian Suppression Following Subcutaneous ZOLADEX 10.8 mg in Premenopausal Women With Hormone Receptor Positive (HR+), Human Epidermal Growth Factor Receptor 2 Negative (HER2-) Advanced Breast Cancer

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 88 (estimated)
• Sponsor: TerSera Therapeutics LLC · Industry
• Sex: Female
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this trial is to evaluate ovarian suppression following treatment with ZOLADEX 10.8 mg by luteinizing hormone (LH).

Detailed description

The purpose of this study is to assess the degree and consistency of ovarian suppression achieved following administration of ZOLADEX 10.8 mg. Ovarian suppression will be evaluated by measuring LH levels over the treatment period.

Conditions

• Advanced Breast Cancer

Interventions

Type	Name	Description
DRUG	ZOLADEX	Participants will receive ZOLADEX as a subcutaneous (SC) injection on Day 1 (Week 1), and Day 85 (Week 12) for a total of 2 treatments.

Timeline

• Start date: 2026-04-29
• Primary completion: 2026-11-30
• Completion: 2027-03-30
• First posted: 2025-12-30
• Last updated: 2026-03-11

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study