Recruiting
Phase 2

Statins

Sponsor:

Rutgers, The State University of New Jersey

Code:

NCT05559164

Conditions

Cardiac Toxicity

Early-stage Breast Cancer

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Lipitor 40mg Tablet

Study Details

Brief summary:

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

Cardiac Toxicity

Early-stage Breast Cancer

Study ID

NCT05559164

Start date

Sep 19, 2022

Status verified date

Nov, 2025

Completion date

Mar 1, 2027

Anticipated

Primary completion date

Sep 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Design

Enrollment

60 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Anti-HER2 targeted therapy + Lipitor 40mg daily

Participants will receive Lipitor 40 mg PO daily while receiving anti-HER2 therapy.

Interventions

Lipitor 40mg Tablet

LIPITOR® (atorvastatin calcium) tablets will be administered orally as a single dose of 40 mg once daily, with or without food

Primary outcome measure

  • 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 [ Time Frame: Five years ]

Central Contacts and Locations

Central contacts

Mridula George, MD

732-235-9081mridula@cinj.rutgers.edu

Coral Omene, MD

732-235-3374co273@cinj.rutgers.edu

Locations

Trinitas Hospital and Comprehensive Cancer Center

Recruiting

Elizabeth, New Jersey, United States, 07202

Contacts

Mridula George, MD

732-235-9081mridula@cinj.rutgers.edu

RWJBarnabas Health - Robert Wood Johnson University Hospital, Hamilton

Recruiting

Hamilton, New Jersey, United States, 08690

Contacts

Mridula George, MD

732-235-2465mridula@cinj.rutgers.edu

RWJBarnabas Health - - Jersey City Medical Medical

Recruiting

Jersey City, New Jersey, United States, 07097

Contacts

mridula George, MD

732-235-9081mridula@cinj.rutgers.edu

Monmouth Medical Center Southern Campus

Recruiting

Lakewood, New Jersey, United States, 08701

Contacts

Mridula George, MD

732-235-9081mridula@cinj.rutgers.edu

RWJBarnabas Health - Monmouth Medical Center

Recruiting

Long Branch, New Jersey, United States, 07740

Contacts

Mridula George, MD

732 -235-9081mridula@cinj.rutgers.edu

Monmouth Community Medical

Recruiting

Long Branch, New Jersey, United States, 07764

Contacts

Mridula George, MD

732-222-6046mridula@CINJ.rutgers.edu

Rutgers Cancer Institute of New Jersey

Recruiting

New Brunswick, New Jersey, United States, 08903

Contacts

Mridula George, MD

732-235-9081mridula@cinj.rutgers.edu

RWJBarnabas Health - Newark Beth Israel Medical Center

Recruiting

Newark, New Jersey, United States, 07112

Contacts

Mridula George, MD

732-235-2465mridula@cinj.rutgers.edu

RWJBarnabas Health - Robert Wood Johnson University Hospital

Recruiting

Somerset, New Jersey, United States, 08873

Contacts

Mridula George, MD

732-235-2465mridula@cinj.rutgers.edu

More Information

Sponsor

Rutgers, The State University of New Jersey

Last update posted

Nov 14, 2025

Last verified

Nov, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Rutgers, The State University of New Jersey on 2025-11-14.