drugset / Trial / NCT07676331
Clinical Study of Local and Systemic Biological Impact of GLP1/GIP-Receptor Agonists in Patients With Breast Cancer: The CLARA Trial
Phase 2
Not yet recruiting
168 enrolled
Universitaire Ziekenhuizen KU Leuven
KU Leuven · collabKing Baudouin Foundation · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
The CLARA trial is a phase II window-of-opportunity trial evaluating how a commonly used weight-loss medication (tirzepatide, a GLP-1/GIP receptor agonist) affects breast cancer biology, alone and in combination with standard hormone therapy (letrozole). The main goal is to determine whether tirzepatide, alone or combined with letrozole, reduces tumor cell growth.
Timeline
- Start
- 2026-08-01
- Primary completion
- 2028-03-01
- Completion
- 2028-05-01
Publications
- Background 1. Dindo et al, 2004, Ann Surg
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Letrozole | Other / unclassified | 2.5 mg | — |
| Comparator | Tirzepatide | Peptide | 5 mg | — |