Loading clinical trials...

Statins for Reduction of Cardiac Toxicity in Patients Receiving HER2 Targeted | Clinical Trials | Clareo Health

RECRUITINGPHASE2

Statins for Reduction of Cardiac Toxicity in Patients Receiving HER2 Targeted

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

NCT05559164•Rutgers, The State University of New Jersey

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.

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.

Eligibility

Age

18 - No limit years

Sex

FEMALE

Healthy Volunteers

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
+4 more criteria

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:
+7 more criteria

Locations (10)

Trinitas Hospital and Comprehensive Cancer Center

Elizabeth, New Jersey, United States

RWJBarnabas Health - Robert Wood Johnson University Hospital, Hamilton

Hamilton, New Jersey, United States

RWJBarnabas Health - - Jersey City Medical Medical

Jersey City, New Jersey, United States

Monmouth Medical Center Southern Campus

Lakewood, New Jersey, United States

RWJBarnabas Health - Monmouth Medical Center

Long Branch, New Jersey, United States

Monmouth Community Medical

Long Branch, New Jersey, United States

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, United States

RWJBarnabas Health - Robert Wood Johnson University Hospital

New Brunswick, New Jersey, United States

RWJBarnabas Health - Newark Beth Israel Medical Center

Newark, New Jersey, United States

RWJBarnabas Health - Robert Wood Johnson University Hospital

Somerset, New Jersey, United States

Key Dates

Start Date

September 19, 2022

Primary Completion Date

September 1, 2026

Completion Date

March 1, 2027

Last Updated

November 14, 2025

Enrollment

ESTIMATED participants

Conditions

Cardiac ToxicityEarly-stage Breast Cancer

Interventions

Lipitor 40mg Tablet

DRUG

Contacts

Mridula George, MD

CONTACT

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

Coral Omene, MD

CONTACT

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

ctDNA-Guided De-Escalation of Adjuvant Chemotherapy With Dalpiciclib in HR-Positive/HER2-Negative Breast Cancer

NCT06970912

Hormone Receptor-Positive Breast CancerHigh-risk Breast Cancer+4 more

View study

RECRUITINGPHASE2

Trastuzumab Deruxtecan Alone or in Combination With Anastrozole for the Treatment of Early Stage HER2 Low, Hormone Receptor Positive Breast Cancer

NCT04553770

Early-stage Breast CancerHormone Receptor Positive Breast Carcinoma+5 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 14, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Statins for Reduction of Cardiac Toxicity in Patients Receiving HER2 Targeted

Inclusion Criteria

Exclusion Criteria

ctDNA-Guided De-Escalation of Adjuvant Chemotherapy With Dalpiciclib in HR-Positive/HER2-Negative Breast Cancer

Trastuzumab Deruxtecan Alone or in Combination With Anastrozole for the Treatment of Early Stage HER2 Low, Hormone Receptor Positive Breast Cancer

REmote iSchemic condItioning in Lymphoma PatIents REceiving ANthraCyclinEs

Cardiometabolic Screening Program

Ultra Hypo-fractionated Adjuvant Whole Breast Radiation Therapy With Simultaneous Integrated Boost for Early-Stage Breast Cancer (H-ASSIST)

Sacubitril/Valsartan in PriMAry preventIoN of the Cardiotoxicity of Systematic breaST canceR trEAtMent (MAINSTREAM)