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

Sponsor
ETOP IBCSG Partners Foundation
Study ID
NCT05896566
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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).

Key Dates

Start date
Jan 23, 2024
Status verified
Feb 2026
Primary completion
Sep 18, 2025
Completion
Sep 18, 2025

Study Design

Enrollment
231 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A: Giredestrant
    Giredestrant
  • Experimental: Arm B: Giredestrant plus triptorelin
    Giredestrant plus triptorelin
  • Active Comparator: Arm C: Anastrozole plus triptorelin
    Anastrozole plus triptorelin

Primary Outcome Measure

Change in Ki 67 [ Time Frame: From date of randomisation until 29 ±3 days post-randomisation ]

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