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

NCT05896566 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 231

Last updated 2026-02-24

No results posted yet for this study

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).

Conditions

Interventions

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.

Sponsors & Collaborators

  • Hoffmann-La Roche

    collaborator INDUSTRY

  • ETOP IBCSG Partners Foundation

    lead NETWORK

Principal Investigators

  • Elisabetta Munzone, MD · European Institute of Oncology, Milano

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-23
Primary Completion
2025-09-18
Completion
2025-09-18

Countries

  • France
  • Germany
  • Ireland
  • Italy
  • Spain
  • Switzerland

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05896566 on ClinicalTrials.gov