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Statins for Reducing Heart Problems in HER2-Positive Breast Cancer

This study is looking at whether taking Lipitor (atorvastatin calcium) 40mg daily can help reduce heart problems (cardiac toxicity) in women with early-stage breast cancer. You could be eligible if you have Stage I-III HER2-positive breast cancer and are scheduled to receive HER2-targeted therapy. The study aims to see if Lipitor can prevent treatment delays or early stops due to heart issues, ultimately improving your long-term health and quality of life. The main goal is to count how many participants experience at least one side effect over five years. The current status of this study is unclear.

Study design
This is a single-arm, open-label Phase 2 study, meaning all 60 participants will receive the study intervention, and both you and your doctors will know what treatment you are getting.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
You will be followed for five years to track any adverse events (side effects).

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05559164

Statins for Reduction of Cardiac Toxicity in Patients Receiving HER2 Targeted

Recruiting
PHASE2Ages 18+InterventionalTreatment
Rutgers, The State University of New Jersey
~60 participants
Updated 2025-11-14 on ClinicalTrials.gov
What's tested:Lipitor 40mg Tablet

At a glance

Recruiting sites
9 of 10 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of Participants With at Least One Adverse Event will be measured using Common Terminology Criteria for Adverse Events (CTCAE) v5.0 for five years
Measured over Five years

Conditions

Cardiac Toxicity
Early-stage Breast Cancer

Explore related trials

Breast CarcinomaERBB2 Gene

Where it's being run

10 sites across 1 states
New Jersey10

Study leadership

  • Mridula George, MD · PRINCIPAL_INVESTIGATOR · Rutgers Cancer Institute of New Jersey

Who to contact

Mridula George, MD
[email protected]
732-235-9081
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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:
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

Exclusion

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:
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

What this trial measures

  • Number of Participants With at Least One Adverse Event will be measured using Common Terminology Criteria for Adverse Events (CTCAE) v5.0 for five yearsFive years

    Adverse events (AEs) will be measured using Common Terminology Criteria for Adverse Events (CTCAE) v5.0 for five years