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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

NCT07676331 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 168

Last updated 2026-07-07

No results posted yet for this study

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.

Conditions

  • Hormone-receptor-positive Breast Cancer
  • Early Breast Cancer

Interventions

DRUG

Tirzepatide

Tirzepatide is a GIP and GLP-1R agonist. It is approved by FDA and EMA as a weight-loss drug for patients with BMI ≥30 kg/m2 or ≥27 kg/m2 and previously diagnosed with at least 1 weight-related comorbidity.

DRUG

Letrozole (Aromatase Inhibitors)

Letrozole is an nonsteroidal aromatase inhibitor (NSAI). It is an adjuvant endocrine treatment indicated for HR+ breast cancer.

Sponsors & Collaborators

  • King Baudouin Foundation

    collaborator OTHER

  • KU Leuven

    collaborator OTHER

  • Universitaire Ziekenhuizen KU Leuven

    lead OTHER

Principal Investigators

  • Patrick Neven, MD, PhD · Universitaire Ziekenhuizen KU Leuven

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-01
Primary Completion
2028-03-01
Completion
2028-05-01
FDA Drug
Yes

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07676331 on ClinicalTrials.gov