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Clinical Study of Local and Systemic Biological Impact of GLP1/GIP-Receptor Agonists in Patients With Breast Cancer: The CLARA Trial

Study acronym: CLARA
StatusNot Yet Recruiting
PhasePhase 2
Started2026-08-01
View on ClinicalTrials.gov ↗

Amendment history

2026-07-03
Study Status, Outcome Measures v1
Re-verified, no change to tracked fields
2026-06-23
Original filing
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.
Trial Details
NCT Number NCT07676331
Lead Sponsor Universitaire Ziekenhuizen KU Leuven
Collaborators: King Baudouin Foundation, KU Leuven
Conditions Hormone-receptor-positive Breast Cancer, Early Breast Cancer
Enrollment 168 participants
Start Date 2026-08-01
Primary Completion 2028-03-01 (estimated)
Study Completion 2028-05-01 (estimated)
Updated on ClinicalTrials.gov 2026-07-07