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.
Voluntary written informed consent of the participant has been obtained prior to any screening procedures
Patient is >18 years of age
Patient is postmenopausal, as defined per local practice
Tumour size of ≥1 cm
Have Type 1 or 2 diabetes mellitus, history of ketoacidosis, or hyperosmolar state or coma.
Have at least 1 laboratory value suggestive of diabetes during screening : HbA1c ≥6.5% (≥48 mmol/mol) or fasting glucose ≥126 mg/dL (≥7.0 mmol/L)
Contralateral in situ BC without systemic treatment
Ipsilateral in situ BC without systemic treatment or radiation therapy
Universitaire Ziekenhuizen KU Leuven
Lead sponsor
King Baudouin Foundation
Collaborator
KU Leuven
Collaborator