Title: A phase II single arm trial of adding simvastatin to dual anti-HER2 therapy in patients with HER2-positive metastatic breast cancer

Principal Investigator: Mothaffar Rimawi, MD, of Baylor College of Medicine 

Description: Researchers are conducting a phase 2 trial to determine if adding simvastatin to dual anti-HER2 therapy will induce a response after progression of HER2-positive metastatic breast cancer.

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Patients whose disease progressed on dual anti-HER2 therapy will receive 80 mg of simvastatin by mouth daily, in combination with their current anti-HER2 therapy regimen.

The primary outcome measure is objective response. Secondary outcome measures include clinical benefit, time to progression, and adverse events.

To be eligible for this study, patients must be women, 18 years of age or older, and have HER2-positive metastatic breast cancer that is not amenable to curative therapy. For a complete list of eligibility criteria, please see the reference.

Status: Recruiting

This study is sponsored by the Baylor Breast Care Center.


ClinicalTrials.gov. Simvastatin plus dual anti-HER2 therapy for metastatic breast cancer (SIMPHONY). NCT03324425. Accessed June 22, 2022.