OncoMatch/Clinical Trials/NCT05559164
Statins for Reduction of Cardiac Toxicity in Patients Receiving HER2 Targeted
Is NCT05559164 recruiting? Yes, currently enrolling (Jun 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
Treatments studied
Other
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)
Demographics
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 →Frequently asked questions
Is NCT05559164 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior HER2-targeted therapy, anthracycline disqualifies patients from enrollment.
Does this trial require ERBB2?
Yes, ERBB2 overexpression is a required biomarker for enrollment.
What disease stage is eligible?
Stage I or II or III is required.
Is this trial open to male patients?
No. This trial enrolls female patients only.
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 qualifyRelated pages