Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Christine Desmedt, PhD
CONTACT
Josephine Van Cauwenberge, MD
CONTACT
Lead
Universitaire Ziekenhuizen KU Leuven
With
CLARA is a randomized, controlled, phase IIb window-of-opportunity trial designed to evaluate the biological effects and safety of tirzepatide, alone or in combination with letrozole, in postmenopausal women with hormone receptor-positive (HR+), HER2-negative, treatment-naïve breast cancer scheduled for primary surgery, who meet the EMA-approved obesity criteria for tirzepatide prescription (BMI ≥30 kg/m² or BMI ≥27 kg/m² with weight-related comorbidities). 168 participants will be randomized equally into four arms: Arm A (Control): Immediate surgery Arm B: 3 weeks of neoadjuvant letrozole alone Arm C: 3 weeks of neoadjuvant tirzepatide alone Arm D: 3 weeks of neoadjuvant tirzepatide combined with letrozole Primary objective is to compare anti-proliferative tumor response in patients receiving immediate surgery, GLP1/GIP RA, letrozole and combined treatment. Secondary objectives are: * To compare adherence to the GLP1/GIP RA, letrozole and combined treatment. * To compare safety * To compare perioperative complications * To explore the feasibility and utility of circulating tumour DNA (ctDNA) in plasma samples collected throughout the study. Exploratory objectives are: * To compare fatigue * To compare body composition changes * To compare changes in genomic risk score * To compare postoperative nausea and vomiting * To compare gastric emptying delays prior to surgery * To compare anti-proliferative tumor response as complete cell cycle arrest (CCCA) * To compare endocrine response * To compare concentrations of letrozole * To compare impact of stress on tumor biology and on clinical and biological effects of treatment
Age
18–any
Sex
FEMALE
Healthy volunteers
Not accepted