Statins for Reduction of Cardiac Toxicity in Patients Receiving HER2 Targeted
STACIE: Statins for Reduction of Cardiac Toxicity in Patients Receiving HER2 Targeted Therapy
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this 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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Official 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
Study sites (10)
NJ
- Trinitas Hospital and Comprehensive Cancer Center · Elizabeth, NJ 07202Mridula George, MD · Study contact · 732-235-9081 · mridula@cinj.rutgers.eduMore trials in Elizabeth
- RWJBarnabas Health - Robert Wood Johnson University Hospital, Hamilton · Hamilton, NJ 08690Mridula George, MD · Study contact · 732-235-2465 · mridula@cinj.rutgers.eduMore trials in Hamilton
- RWJBarnabas Health - - Jersey City Medical Medical · Jersey City, NJ 07097mridula George, MD · Study contact · 732-235-9081 · mridula@cinj.rutgers.eduMore trials in Jersey City
- Monmouth Medical Center Southern Campus · Lakewood, NJ 08701Mridula George, MD · Study contact · 732-235-9081 · mridula@cinj.rutgers.eduMore trials in Lakewood
- RWJBarnabas Health - Monmouth Medical Center · Long Branch, NJ 07740Mridula George, MD · Study contact · 732 -235-9081 · mridula@cinj.rutgers.eduMore trials in Long Branch
- Monmouth Community Medical · Long Branch, NJ 07764Mridula George, MD · Study contact · 732-222-6046 · mridula@CINJ.rutgers.eduMore trials in Long Branch
- Rutgers Cancer Institute of New Jersey · New Brunswick, NJ 08903Mridula George, MD · Study contact · 732-235-9081 · mridula@cinj.rutgers.eduMore trials in New Brunswick
- RWJBarnabas Health - Robert Wood Johnson University Hospital · New Brunswick, NJ 08903Mridula George, MD · Study contact · 732-235-9081 · mridula@cinj.rutgers.eduMore trials in New Brunswick
- RWJBarnabas Health - Newark Beth Israel Medical Center · Newark, NJ 07112Mridula George, MD · Study contact · 732-235-2465 · mridula@cinj.rutgers.eduMore trials in Newark
- RWJBarnabas Health - Robert Wood Johnson University Hospital · Somerset, NJ 08873Mridula George, MD · Study contact · 732-235-2465 · mridula@cinj.rutgers.eduMore trials in Somerset