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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 2INTERVENTIONAL

Statins for Reduction of Cardiac Toxicity in Patients Receiving HER2 Targeted

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

Statins for Reduction of Cardiac Toxicity in Patients Receiving HER2 Targeted (NCT05559164) is a Phase 2 interventional studying Cardiac Toxicity and Early-stage Breast Cancer, sponsored by Rutgers, The State University of New Jersey. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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 Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Cardiac Toxicity and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 60 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Cardiac Toxicity subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: - 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. white blood cell count (ANC) at least 1000/uL II. platelet count ≥ 100,000/uL III. blood count (hemoglobin) at least 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 kidney function (creatinine clearance) at least 50 mL/min as estimated using the Cockcroft-Gault formula - Ability to understand the nature of this study protocol and give written willing to sign a consent form - Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures Who Should NOT Join This Trial: - 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: ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

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

Locations (10)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

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

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT05559164), the sponsor (Rutgers, The State University of New Jersey), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT05559164 clinical trial studying?

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. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT05559164?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT05559164?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT05559164. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT05559164. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.