Actively Recruiting
Statins for Reduction of Cardiac Toxicity in Patients Receiving HER2 Targeted
Led by Rutgers, The State University of New Jersey · Updated on 2025-11-14
60
Participants Needed
10
Research Sites
232 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Statins for Reduction of Cardiac Toxicity in Patients Receiving HER2 Targeted
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female patients aged 18 years or older
- Histologically and/or cytologically confirmed diagnosis of Stage I-III breast cancer, including inflammatory breast cancer
- Scheduled to receive neoadjuvant or adjuvant HER2 targeted therapy
- Female patients of childbearing potential must have a negative pregnancy test before enrollment and agree to use effective contraception during therapy
- Baseline left ventricular ejection fraction (LVEF) of 50% or higher
- Prior cancers allowed if no evidence of disease in last 5 years
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
- No previous treatment with HER2 targeted therapy or anthracycline-based chemotherapy
- Adequate bone marrow function: ANC 1000/uL or greater, platelet count 100,000/uL or greater, hemoglobin 9.0 g/dL or greater
- Adequate liver function: total bilirubin no more than 1.5 times upper limit of normal (ULN), AST and ALT no more than 5 times ULN
- Adequate kidney function: creatinine less than 1.5 times ULN or creatinine clearance 50 mL/min or greater
- Ability to understand the study and provide written informed consent
- Willingness and ability to comply with study visits, treatment plans, and tests
You will not qualify if you...
- Stage IV breast cancer
- Current use of statin medications
- Uncontrolled hypertension with systolic blood pressure over 190 mm Hg or diastolic over 100 mm Hg
- Active liver disease
- Current use of CYP 3A4 inhibitors
- Any condition or lab abnormality posing unacceptable risk as judged by the investigator
- Life expectancy less than 12 weeks
- Pregnancy or breastfeeding
- Pre-existing sensory neuropathy greater than grade one
- Significant cardiovascular disease including baseline LVEF below 50%, Class III or IV heart failure, recent myocardial infarction within 6 months, or symptomatic arrhythmia
- Major surgery without full recovery within 4 weeks prior to screening
- Active infection or uncontrolled HIV, Hepatitis B or C
- History of allergy or hypersensitivity to study drugs
- History of interstitial lung disease or related pulmonary conditions
- Any significant medical, laboratory, or psychiatric condition preventing participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 10 locations
1
Trinitas Hospital and Comprehensive Cancer Center
Elizabeth, New Jersey, United States, 07202
Actively Recruiting
2
RWJBarnabas Health - Robert Wood Johnson University Hospital, Hamilton
Hamilton, New Jersey, United States, 08690
Actively Recruiting
3
RWJBarnabas Health - - Jersey City Medical Medical
Jersey City, New Jersey, United States, 07097
Actively Recruiting
4
Monmouth Medical Center Southern Campus
Lakewood, New Jersey, United States, 08701
Actively Recruiting
5
RWJBarnabas Health - Monmouth Medical Center
Long Branch, New Jersey, United States, 07740
Actively Recruiting
6
Monmouth Community Medical
Long Branch, New Jersey, United States, 07764
Actively Recruiting
7
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08903
Actively Recruiting
8
RWJBarnabas Health - Robert Wood Johnson University Hospital
New Brunswick, New Jersey, United States, 08903
Not Yet Recruiting
9
RWJBarnabas Health - Newark Beth Israel Medical Center
Newark, New Jersey, United States, 07112
Actively Recruiting
10
RWJBarnabas Health - Robert Wood Johnson University Hospital
Somerset, New Jersey, United States, 08873
Actively Recruiting
Research Team
M
Mridula George, MD
CONTACT
C
Coral Omene, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here