Statins for Reduction of Cardiac Toxicity in Patients Receiving HER2 Targeted

Recruiting now · Phase 2

Conditions studied: Cardiac Toxicity, Early-stage Breast Cancer

In brief

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.

Key facts

Study ID

NCT05559164

Run by

Rutgers, The State University of New Jersey

People needed

60

Starts

2022-09-19

Expected to finish

2027-03-01

Last updated by the study team

2025-11-14

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Histologically and/or cytologically confirmed diagnosis of Stage I-III female breast cancer (including inflammatory breast cancer)
• Scheduled to receive neoadjuvant/adjuvant HER2 targeted therapy
• Between ≥18 years of age
• Female patients of childbearing potential must have a negative pregnancy test (serum or urine) prior to enrollment. Female patients must agree to use effective barrier contraception during the period of therapy
• Baseline LVEF ≥ 50%
• Prior cancers allowed if no evidence of disease in last 5 years
• ECOG 0-2
• No prior history of treatment with HER2 targeted therapy or anthracyclines based chemotherapy
• Adequate bone marrow function:
• I. ANC ≥ 1000/uL II. platelet count ≥ 100,000/uL III. hemoglobin ≥ 9.0 g/dL
• Adequate hepatic function: I. Total bilirubin ≤ 1.5 X ULN II. AST (SGOT) ≤ 5 X ULN III. ALT (SGPT) ≤ 5 X ULN
• Adequate renal function, Creatinine < 1.5x institutional ULN or calculated creatinine clearance ≥ 50 mL/min as estimated using the Cockcroft-Gault formula
• Ability to understand the nature of this study protocol and give written informed consent
• Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures

You may not qualify if…

• Participants with stage IV breast cancer
• Participants currently taking statins
• Uncontrolled hypertension (systolic blood pressure >190 mm Hg or diastolic blood pressure >100 mm Hg)
• No active liver disease
• Current use of CYP 3A4 inhibitors
• Any condition including the presence of laboratory abnormalities, which, in the opinion of the investigator places the subject at unacceptable risk if he/she were to participate in the study
• Life expectancy < 12 weeks
• Pregnancy (positive pregnancy test) or lactation
• Pre-existing sensory neuropathy > grade one
• Has significant cardiovascular disease, such as:
• LVEF < 50% at baseline as assessed by ECHO (preferred) i) Class III or Class IV myocardial disease as described by the New York Heart Association ii) Recent history (within 6 months prior to enrollment) of myocardial infarction; or iii) Symptomatic arrhythmia at the time of randomization
• Major surgery without complete recovery in the past four weeks prior to screening
• Concurrent active infection
• Participant with uncontrolled and/ or active infection with HIV, Hepatitis B or Hepatitis C
• Participant who has a history of allergy or hypersensitivity to any of the study drugs
• Participant with a history of interstitial lung disease, history of slowly progressive dyspnea and unproductive cough, sarcoidosis, silicosis, interstitial pulmonary fibrosis, pulmonary hypersensitivity pneumonitis
• Any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study

Where it is running

• RWJBarnabas Health - Robert Wood Johnson University Hospital — Somerset, New Jersey, United States (enrolling)
• RWJBarnabas Health - Robert Wood Johnson University Hospital, Hamilton — Hamilton, New Jersey, United States (enrolling)
• RWJBarnabas Health - - Jersey City Medical Medical — Jersey City, New Jersey, United States (enrolling)
• Monmouth Medical Center Southern Campus — Lakewood, New Jersey, United States (enrolling)
• RWJBarnabas Health - Monmouth Medical Center — Long Branch, New Jersey, United States (enrolling)
• Monmouth Community Medical — Long Branch, New Jersey, United States (enrolling)
• Rutgers Cancer Institute of New Jersey — New Brunswick, New Jersey, United States (enrolling)
• Trinitas Hospital and Comprehensive Cancer Center — Elizabeth, New Jersey, United States (enrolling)
• RWJBarnabas Health - Newark Beth Israel Medical Center — Newark, New Jersey, United States (enrolling)
• RWJBarnabas Health - Robert Wood Johnson University Hospital — New Brunswick, New Jersey, United States

Full record on ClinicalTrials.gov

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