IBCSG 67-22 PREcoopERA: A Window-of-Opportunity trial of giredestrant +/- triptorelin vs. anastrozole + triptorelin in premenopausal patients with ER-positive/HER2-negative early breast cancer.

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2022-503013-32-00

Acronym

67-22 PREcoopERA

Enrollment

175

Registered

2023-11-28

Start date

2024-01-29

Completion date

2025-09-18

Last updated

2025-08-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ER-positive/HER2-negative early breast cancer

Brief summary

The primary endpoint is the change in Ki-67 (Ki-67-labeling index, the percentage of immunostaining cells measured by IHC in the central laboratory) between a pre-treatment tumor biopsy and a post-treatment tumor re-biopsy (analyzed on the natural logarithmic scale).

Detailed description

 Complete cell cycle arrest (CCCA), defined as Ki-67 ≤2.7% on post-treatment tumor re-biopsy, by visual image analysis.  Adverse events according to CTCAE v5.0.

Interventions

DRUGPamorelin® LA 3

DRUG75 mg Pulver und Lösungsmittel zur Herstellung einer Depot-Injektionssuspension

DRUGRO7197597

DRUGANASTROZOLE ACCORD 1 mg

DRUGcomprimé pelliculé

Eligibility

Sex/Gender

All

Age

18 Years to 64 Years

Design outcomes

Secondary

Measure	Time frame
 Complete cell cycle arrest (CCCA), defined as Ki-67 ≤2.7% on post-treatment tumor re-biopsy, by visual image analysis.  Adverse events according to CTCAE v5.0.	—

Primary

Measure	Time frame
The primary endpoint is the change in Ki-67 (Ki-67-labeling index, the percentage of immunostaining cells measured by IHC in the central laboratory) between a pre-treatment tumor biopsy and a post-treatment tumor re-biopsy (analyzed on the natural logarithmic scale).	—

Countries

France, Germany, Hungary, Ireland, Italy, Spain, Sweden

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026