NCT05559164

Statins for Reduction of Cardiac Toxicity in Patients Receiving HER2 Targeted

STACIE: Statins for Reduction of Cardiac Toxicity in Patients Receiving HER2 Targeted Therapy

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Rutgers, The State University of New Jersey · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study proposes that the addition of statins reduces the treatment delays or early discontinuations secondary to cardiotoxicity in patients with Stage I-III HER2 positive breast being treated with anti-HER2 therapy.

Detailed description

A single arm open-label phase 2 study to evaluate the cardioprotective effects of statins in patients with Stage I-III HER2 positive breast cancer receiving HER2 targeted therapy. This study will evaluate the hypothesis that addition of statins will reduce treatment delays/discontinuations related to symptomatic/asymptomatic cardiac dysfunction in patients being treated with anti-HER2 therapy. The long-term goal of this study is to improve disease related outcomes and quality of life measures in patients being treated with anti-HER2 therapy.

Conditions

• Cardiac Toxicity
• Early-stage Breast Cancer

Interventions

Type	Name	Description
DRUG	Lipitor 40mg Tablet	LIPITOR® (atorvastatin calcium) tablets will be administered orally as a single dose of 40 mg once daily, with or without food

Timeline

• Start date: 2022-09-19
• Primary completion: 2026-09-01
• Completion: 2027-03-01
• First posted: 2022-09-29
• Last updated: 2025-11-14

Locations

10 sites across 1 country: United States

Regulatory

• FDA-regulated drug study