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

Sponsor
Universitaire Ziekenhuizen KU Leuven
Study ID
NCT07676331
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Tirzepatide — DRUG
    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.
  • Letrozole (Aromatase Inhibitors) — DRUG
    Letrozole is an nonsteroidal aromatase inhibitor (NSAI). It is an adjuvant endocrine treatment indicated for HR+ breast cancer.

Study Details

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.

Key Dates

First listed
Jun 30, 2026
Start date
Aug 1, 2026
Status verified
Jun 2026
Primary completion
Mar 1, 2028
Completion
May 1, 2028

Study Design

Enrollment
168 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • No Intervention: Arm A (Control): Immediate surgery
    Patient undergoes immediate surgery without intervention
  • Active Comparator: Arm B: letrozole
    3 weeks of neoadjuvant letrozole 2.5 mg/d
  • Active Comparator: Arm C: tirzepatide
    3 weeks of neoadjuvant tirzepatide. Cycle 1: 2.5 mg/w Cycle 2: 5 mg/w Cycle 3: 5 mg/w
  • Active Comparator: Arm D: letrozole + tirzepatide
    3 weeks of neoadjuvant letrozole 2.5mg/d and tirzepatide: * Cycle 1: 2.5mg/w * Cycle 2: 5mg/w * Cycle 3: 5mg/w

Primary Outcome Measure

Ki67 proliferation marker [ Time Frame: From enrollment till time of surgery (4-5 weeks) ]

Central Contacts

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