Statins for Reduction of Cardiac Toxicity in Patients Receiving HER2 Targeted

NCT05559164 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: 042201Pro2022000290
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 10

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

Outcome Measures

Primary Outcomes (1)

• 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

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

  Five years

Secondary Outcomes (1)

• Patient reported outcome (PRO) for pain measured by the quality of Life questionnaire using PROMIS to measure pain

  Baseline, six, twelve and fifteen months

Other Outcomes (4)

• Patient reported outcome (PRO) for pain measured by the quality of Life questionnaire using PROMIS to measure fatigue

  Baseline, six, twelve and fifteen months

• Patient reported outcome (PRO) for pain measured by the quality of Life questionnaire using PROMIS to measure physical functioning

  Baseline, six, twelve and fifteen months

• Patient reported outcome (PRO) for pain measured by the quality of Life questionnaire using PROMIS to measure emotional distress

  Baseline, six, twelve and fifteen months

Study Arms (1)

Anti-HER2 targeted therapy + Lipitor 40mg daily

EXPERIMENTAL

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

Drug: Lipitor 40mg Tablet

Interventions

Lipitor 40mg Tablet DRUG

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

Also known as: Atorvastatin Calcium

Anti-HER2 targeted therapy + Lipitor 40mg daily

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: • 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.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead

Study Sites (10)

Trinitas Hospital and Comprehensive Cancer Center

Elizabeth, New Jersey, 07202, United States

RECRUITING

RWJBarnabas Health - Robert Wood Johnson University Hospital, Hamilton

Hamilton, New Jersey, 08690, United States

RECRUITING

RWJBarnabas Health - - Jersey City Medical Medical

Jersey City, New Jersey, 07097, United States

RECRUITING

Monmouth Medical Center Southern Campus

Lakewood, New Jersey, 08701, United States

RECRUITING

RWJBarnabas Health - Monmouth Medical Center

Long Branch, New Jersey, 07740, United States

RECRUITING

Monmouth Community Medical

Long Branch, New Jersey, 07764, United States

RECRUITING

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, 08903, United States

RECRUITING

RWJBarnabas Health - Robert Wood Johnson University Hospital

New Brunswick, New Jersey, 08903, United States

NOT YET RECRUITING

RWJBarnabas Health - Newark Beth Israel Medical Center

Newark, New Jersey, 07112, United States

RECRUITING

RWJBarnabas Health - Robert Wood Johnson University Hospital

Somerset, New Jersey, 08873, United States

RECRUITING

MeSH Terms

Conditions

Cardiotoxicity; Breast Neoplasms

Interventions

Atorvastatin; Tablets

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders; Radiation Injuries; Wounds and Injuries; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Mridula George, MD

  Rutgers Cancer Institute of New Jersey

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mridula George, MD

CONTACT

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

Coral Omene, MD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Model Details: Stage I-III HER2positive breast cancer receiving anti-HER2 therapy. Participants will receive Lipitor 40 mg PO daily. Anti-HER2 targeted therapy + Lipitor 40mg daily

Study Record Dates

• First Submitted: September 26, 2022
• First Posted: September 29, 2022
• Study Start: September 19, 2022
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: November 14, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (10)