OncoMatch/Clinical Trials/NCT05559164
Statins for Reduction of Cardiac Toxicity in Patients Receiving HER2 Targeted
Is NCT05559164 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Lipitor 40mg Tablet for cardiac toxicity.
Treatment: Lipitor 40mg Tablet — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Biomarker criteria
Required: HER2 (ERBB2) overexpression
Disease stage
Required: Stage I, II, III
Excluded: Stage IV
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: HER2-targeted therapy
No prior history of treatment with HER2 targeted therapy
Cannot have received: anthracycline
No prior history of treatment with...anthracyclines based chemotherapy
Lab requirements
Blood counts
ANC ≥ 1000/uL; platelet count ≥ 100,000/uL; hemoglobin ≥ 9.0 g/dL
Kidney function
Creatinine < 1.5x institutional ULN or calculated creatinine clearance ≥ 50 mL/min as estimated using the Cockcroft-Gault formula
Liver function
Total bilirubin ≤ 1.5 X ULN; AST (SGOT) ≤ 5 X ULN; ALT (SGPT) ≤ 5 X ULN; No active liver disease
Cardiac function
Baseline LVEF ≥ 50%; No significant cardiovascular disease (LVEF < 50% at baseline, NYHA Class III/IV, recent MI within 6 months, symptomatic arrhythmia)
Adequate bone marrow function: ANC ≥ 1000/uL, platelet count ≥ 100,000/uL, hemoglobin ≥ 9.0 g/dL; Adequate hepatic function: Total bilirubin ≤ 1.5 X ULN, AST (SGOT) ≤ 5 X ULN, ALT (SGPT) ≤ 5 X ULN; Adequate renal function, Creatinine < 1.5x institutional ULN or calculated creatinine clearance ≥ 50 mL/min; Baseline LVEF ≥ 50%; No active liver disease; Has significant cardiovascular disease, such as: LVEF < 50% at baseline as assessed by ECHO (preferred), Class III or Class IV myocardial disease as described by the New York Heart Association, Recent history (within 6 months prior to enrollment) of myocardial infarction; or Symptomatic arrhythmia at the time of randomization
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Trinitas Hospital and Comprehensive Cancer Center · Elizabeth, New Jersey
- RWJBarnabas Health - Robert Wood Johnson University Hospital, Hamilton · Hamilton, New Jersey
- RWJBarnabas Health - - Jersey City Medical Medical · Jersey City, New Jersey
- Monmouth Medical Center Southern Campus · Lakewood, New Jersey
- RWJBarnabas Health - Monmouth Medical Center · Long Branch, New Jersey
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify