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Statins for Reduction of Cardiac Toxicity in Patients Receiving HER2 Targeted

RecruitingPhase 2

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

Who can join

Ages 18 and older · Women

Full eligibility criteria
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

About the study

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.

What is being tested

Sponsor: Rutgers, The State University of New Jersey · Participants: 60 · Started: Sep 19, 2022

Contact the study team

Official record on ClinicalTrials.gov — NCT05559164

Locations in the U.S.

New JerseyTrinitas Hospital and Comprehensive Cancer Center, Elizabeth
RWJBarnabas Health - Robert Wood Johnson University Hospital, Hamilton, Hamilton
RWJBarnabas Health - - Jersey City Medical Medical, Jersey City
Monmouth Medical Center Southern Campus, Lakewood
Monmouth Community Medical, Long Branch
RWJBarnabas Health - Monmouth Medical Center, Long Branch
RWJBarnabas Health - Robert Wood Johnson University Hospital, New Brunswick (Not yet recruiting)
Rutgers Cancer Institute of New Jersey, New Brunswick
RWJBarnabas Health - Newark Beth Israel Medical Center, Newark
RWJBarnabas Health - Robert Wood Johnson University Hospital, Somerset

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.