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Triptorelin

Decapeptyl, Trelstar, Gonapeptyl, Pamorelin

Quick Stats
Studies 178
Trials 100
Overview Studies Clinical Trials
Recruiting PHASE2 INTERVENTIONAL NCT05896566

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

View on ClinicalTrials.gov Updated Dec 15, 2025

Brief 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.

Interventions

Name: Giredestrant
Type: DRUG
Description: Giredestrant: 30 mg daily, PO from day 1 until the day of re-biopsy/surgery.
Name: Triptorelin
Type: DRUG
Description: 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).
Name: Anastrozole
Type: DRUG
Description: Anastrozole: 1 mg daily, PO from day 1 until the day of re-biopsy/surgery.

Primary Outcomes

Measure: Change in Ki 67
TimeFrame: From date of randomisation until 29 ±3 days post-randomisation
Description: The primary endpoint is the change in Ki 67 (Ki 67-labeling index, the percentage immunostaining cells measured by IHC in central laboratory) between the pre-treatment tumor biopsy and a post-treatment tumor re-biopsy (analyzed on the natural logarithm scale).

Trial Information

NCT ID

NCT05896566

Status

Recruiting

Study Type

INTERVENTIONAL

Phases

PHASE2

Sponsor

ETOP IBCSG Partners Foundation

Last Updated

December 15, 2025