Using statins to reduce heart problems in breast cancer patients receiving HER2 therapy

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

This study is testing if adding a cholesterol-lowering medication called Lipitor can help protect the hearts of women with early-stage HER2 positive breast cancer who are getting treatment.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: Rutgers, The State University of New Jersey (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 10 sites (Elizabeth, New Jersey and 9 other locations)
• Trial ID: NCT05559164 on ClinicalTrials.gov

What this trial studies

This phase 2 study investigates whether adding statins can help prevent cardiac toxicity in women with Stage I-III HER2 positive breast cancer undergoing anti-HER2 treatment. It is a single-arm, open-label trial that aims to assess the cardioprotective effects of Lipitor (40mg) in this patient population. The study will monitor treatment delays and discontinuations due to cardiac dysfunction, with the ultimate goal of improving patient outcomes and quality of life during cancer therapy.

Who should consider this trial

Good fit: Ideal candidates are women aged 18 and older with Stage I-III HER2 positive breast cancer scheduled for HER2 targeted therapy.

Not a fit: Patients with prior treatment using HER2 targeted therapy or anthracyclines may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could help patients continue their cancer treatment without interruptions caused by heart-related issues.

How similar studies have performed: While the use of statins for cardioprotection in cancer therapy is being explored, this specific approach in HER2 positive breast cancer is relatively novel.

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

Where this trial is running

Elizabeth, New Jersey and 9 other locations

• Trinitas Hospital and Comprehensive Cancer Center — Elizabeth, New Jersey, United States (Recruiting)
• RWJBarnabas Health - Robert Wood Johnson University Hospital, Hamilton — Hamilton, New Jersey, United States (Recruiting)
• RWJBarnabas Health - - Jersey City Medical Medical — Jersey City, New Jersey, United States (Recruiting)
• Monmouth Medical Center Southern Campus — Lakewood, New Jersey, United States (Recruiting)
• RWJBarnabas Health - Monmouth Medical Center — Long Branch, New Jersey, United States (Recruiting)
• Monmouth Community Medical — Long Branch, New Jersey, United States (Recruiting)
• Rutgers Cancer Institute of New Jersey — New Brunswick, New Jersey, United States (Recruiting)
• RWJBarnabas Health - Robert Wood Johnson University Hospital — New Brunswick, New Jersey, United States (Not_yet_recruiting)
• RWJBarnabas Health - Newark Beth Israel Medical Center — Newark, New Jersey, United States (Recruiting)
• RWJBarnabas Health - Robert Wood Johnson University Hospital — Somerset, New Jersey, United States (Recruiting)

Study contacts

• Principal investigator: Mridula George, MD — Rutgers Cancer Institute of New Jersey
• Study coordinator: Mridula George, MD

Conditions Cardiac Toxicity; Early-stage Breast Cancer