Statins for Reduction of Cardiac Toxicity in Patients Receiving HER2 Targeted

STACIE: Statins for Reduction of Cardiac Toxicity in Patients Receiving HER2 Targeted Therapy

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.

Study Overview

• Status: Recruiting
• Conditions: Cardiac Toxicity; Early-stage Breast Cancer
• Intervention / Treatment: Drug: Lipitor 40mg Tablet

Detailed Description

A single arm open-label phase 2 study to evaluate the cardioprotective effects of statins in patients with Stage I-III HER2 positive breast cancer receiving HER2 targeted therapy. This study will evaluate the hypothesis that addition of statins will reduce treatment delays/discontinuations related to symptomatic/asymptomatic cardiac dysfunction in patients being treated with anti-HER2 therapy. The long-term goal of this study is to improve disease related outcomes and quality of life measures in patients being treated with anti-HER2 therapy.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Mridula George, MD; Phone Number: 732-235-9081; Email: mridula@cinj.rutgers.edu
• Study Contact Backup: Name: Coral Omene, MD; Phone Number: 732-235-3374; Email: co273@cinj.rutgers.edu

Study Locations

• United States
  • New Jersey
    • Elizabeth, New Jersey, United States, 07202
      • Recruiting
      • Trinitas Hospital and Comprehensive Cancer Center
      • Contact: Mridula George, MD; Phone Number: 732-235-9081; Email: mridula@cinj.rutgers.edu
    • Hamilton, New Jersey, United States, 08690
      • Recruiting
      • RWJBarnabas Health - Robert Wood Johnson University Hospital, Hamilton
      • Contact: Mridula George, MD; Phone Number: 732-235-2465; Email: mridula@cinj.rutgers.edu
    • Jersey City, New Jersey, United States, 07097
      • Recruiting
      • RWJBarnabas Health - - Jersey City Medical Medical
      • Contact: Mridula George, MD; Phone Number: 732-235-9081; Email: mridula@cinj.rutgers.edu
    • Lakewood, New Jersey, United States, 08701
      • Recruiting
      • Monmouth Medical Center Southern Campus
      • Contact: Mridula George, MD; Phone Number: 732-235-9081; Email: mridula@cinj.rutgers.edu
    • Long Branch, New Jersey, United States, 07740
      • Recruiting
      • RWJBarnabas Health - Monmouth Medical Center
      • Contact: Mridula George, MD; Phone Number: 732 -235-9081; Email: mridula@cinj.rutgers.edu
    • Long Branch, New Jersey, United States, 07764
      • Recruiting
      • Monmouth Community Medical
      • Contact: Mridula George, MD; Phone Number: 732-222-6046; Email: mridula@CINJ.rutgers.edu
    • New Brunswick, New Jersey, United States, 08903
      • Recruiting
      • Rutgers Cancer Institute of New Jersey
      • Contact: Mridula George, MD; Phone Number: 732-235-9081; Email: mridula@cinj.rutgers.edu
    • New Brunswick, New Jersey, United States, 08903
      • Not yet recruiting
      • RWJBarnabas Health - Robert Wood Johnson University Hospital
      • Contact: Mridula George, MD; Phone Number: 732-235-9081; Email: mridula@cinj.rutgers.edu
    • Newark, New Jersey, United States, 07112
      • Recruiting
      • RWJBarnabas Health - Newark Beth Israel Medical Center
      • Contact: Mridula George, MD; Phone Number: 732-235-2465; Email: mridula@cinj.rutgers.edu
    • Somerset, New Jersey, United States, 08873
      • Recruiting
      • RWJBarnabas Health - Robert Wood Johnson University Hospital
      • Contact: Mridula George, MD; Phone Number: 732-235-2465; Email: mridula@cinj.rutgers.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Anti-HER2 targeted therapy + Lipitor 40mg daily; Participants will receive Lipitor 40 mg PO daily while receiving anti-HER2 therapy.	Drug: Lipitor 40mg Tablet; LIPITOR® (atorvastatin calcium) tablets will be administered orally as a single dose of 40 mg once daily, with or without food; Other Names: Atorvastatin Calcium

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient reported outcome (PRO) for pain measured by the quality of Life questionnaire using PROMIS to measure pain	Quality of Life questionnaire using PROMIS will be administered at baseline, six, twelve and fifteen months	Baseline, six, twelve and fifteen months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient reported outcome (PRO) for pain measured by the quality of Life questionnaire using PROMIS to measure fatigue	Quality of Life questionnaire using PROMIS will be administered at baseline six, twelve and fifteen months	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	Quality of Life questionnaire using PROMIS will be administered at baseline six, twelve and fifteen months 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	Quality of Life questionnaire using PROMIS will be administered at baseline six, twelve and fifteen months to measure emotional distress	Baseline, six, twelve and fifteen months
Patient reported outcome (PRO) for pain measured by the quality of Life questionnaire using PROMIS to measure social participation	Quality of Life questionnaire using PROMIS will be administered at baseline six, twelve and fifteen months to measure social participation	Baseline, six, twelve and fifteen months

Collaborators and Investigators

• Sponsor: Rutgers, The State University of New Jersey
• Investigators: Principal Investigator: Mridula George, MD, Rutgers Cancer Institute of New Jersey

Study record dates

Study Major Dates

• Study Start (Actual): September 19, 2022
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): March 1, 2027

Study Registration Dates

• First Submitted: September 26, 2022
• First Submitted That Met QC Criteria: September 26, 2022
• First Posted (Actual): September 29, 2022

Study Record Updates

• Last Update Posted (Estimated): November 14, 2025
• Last Update Submitted That Met QC Criteria: November 13, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Wounds and Injuries; Pathologic Processes; Neoplasms by Site; Neoplasms; Heart Diseases; Chemically-Induced Disorders; Skin Diseases; Breast Diseases; Drug-Related Side Effects and Adverse Reactions; Radiation Injuries; Pathological Conditions, Signs and Symptoms; Skin and Connective Tissue Diseases; Breast Neoplasms; Cardiotoxicity; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pharmaceutical Preparations; Fatty Acids; Lipids; Dosage Forms; Azoles; Pyrroles; Heptanoic Acids; Atorvastatin; Tablets
• Other Study ID Numbers: 042201; Pro2022000290 (Other Identifier: Rutgers, The State University of New Jersey)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes