NCT05896566

A Window-of-Opportunity Trial of Giredestrant +/- Triptorelin vs. Anastrozole + Triptorelin in Premenopausal Patients With ER-positive/HER2-negative Early Breast Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 231 (actual)
• Sponsor: ETOP IBCSG Partners Foundation · Network
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

PREcoopERA is a randomized (2:2:1), multicenter, open-label, three-arm (A, B, C), Window-of-Opportunity (WOO) trial to evaluate the activity and safety of giredestrant (A) versus giredestrant plus triptorelin (B) versus anastrozole plus triptorelin (C).

Detailed description

The primary objectives are: * to determine if 4 weeks of giredestrant plus triptorelin provides greater anti-proliferative activity than anastrozole plus triptorelin among premenopausal patients with ER-positive/HER2-negative operable invasive breast cancer. * to determine if 4 weeks of giredestrant without triptorelin provides anti-proliferative activity that is similar (non-inferior) to giredestrant plus triptorelin among premenopausal patients with ER-positive/HER2-negative operable invasive breast cancer.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	Giredestrant	Giredestrant: 30 mg daily, PO from day 1 until the day of re-biopsy/surgery.
DRUG	Triptorelin	Triptorelin: 3.75 mg IM on day 1. Note: If re-biopsy/surgery cannot be done on day 29 (±3 days) from the first injection, then a second dose of triptorelin should be given on day 29 (±3 days).
DRUG	Anastrozole	Anastrozole: 1 mg daily, PO from day 1 until the day of re-biopsy/surgery.

Timeline

• Start date: 2024-01-23
• Primary completion: 2025-09-18
• Completion: 2025-09-18
• First posted: 2023-06-09
• Last updated: 2026-02-24

Locations

37 sites across 6 countries: France, Germany, Ireland, Italy, Spain, Switzerland