Statins for Reduction of Cardiac Toxicity in Patients Receiving HER2 Targeted

Description

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.

Conditions

Cardiac Toxicity, Early-stage Breast Cancer

Study Overview

Study Details

Study overview

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.

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

Statins for Reduction of Cardiac Toxicity in Patients Receiving HER2 Targeted

Condition
Cardiac Toxicity
Intervention / Treatment

-

Contacts and Locations

Elizabeth

Trinitas Hospital and Comprehensive Cancer Center, Elizabeth, New Jersey, United States, 07202

Hamilton

RWJBarnabas Health - Robert Wood Johnson University Hospital, Hamilton, Hamilton, New Jersey, United States, 08690

Jersey City

RWJBarnabas Health - - Jersey City Medical Medical, Jersey City, New Jersey, United States, 07097

Lakewood

Monmouth Medical Center Southern Campus, Lakewood, New Jersey, United States, 08701

Long Branch

RWJBarnabas Health - Monmouth Medical Center, Long Branch, New Jersey, United States, 07740

Long Branch

Monmouth Community Medical, Long Branch, New Jersey, United States, 07764

New Brunswick

Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey, United States, 08903

New Brunswick

RWJBarnabas Health - Robert Wood Johnson University Hospital, New Brunswick, New Jersey, United States, 08903

Newark

RWJBarnabas Health - Newark Beth Israel Medical Center, Newark, New Jersey, United States, 07112

Somerset

RWJBarnabas Health - Robert Wood Johnson University Hospital, Somerset, New Jersey, United States, 08873

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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:
  • * 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
  • * 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:
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

Rutgers, The State University of New Jersey,

Mridula George, MD, PRINCIPAL_INVESTIGATOR, Rutgers Cancer Institute of New Jersey

Study Record Dates

2027-03-01