RECRUITING

Statins for Reduction of Cardiac Toxicity in Patients Receiving HER2 Targeted

Conditions

Cardiac Toxicity Early-stage Breast Cancer

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2022-09-19

Study Completion:2027-03-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05559164

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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

Inclusion Criteria

Exclusion 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

Contacts and Locations

Study Contact

Mridula George, MD

CONTACT

732-235-9081

mridula@cinj.rutgers.edu

Coral Omene, MD

CONTACT

732-235-3374

co273@cinj.rutgers.edu

Principal Investigator

Mridula George, MD

PRINCIPAL_INVESTIGATOR

Rutgers Cancer Institute of New Jersey

Study Locations (Sites)

Trinitas Hospital and Comprehensive Cancer Center

Elizabeth, New Jersey, 07202

United States

RWJBarnabas Health - Robert Wood Johnson University Hospital, Hamilton

Hamilton, New Jersey, 08690

United States

RWJBarnabas Health - - Jersey City Medical Medical

Jersey City, New Jersey, 07097

United States

Monmouth Medical Center Southern Campus

Lakewood, New Jersey, 08701

United States

RWJBarnabas Health - Monmouth Medical Center

Long Branch, New Jersey, 07740

United States

Monmouth Community Medical

Long Branch, New Jersey, 07764

United States

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, 08903

United States

RWJBarnabas Health - Robert Wood Johnson University Hospital

New Brunswick, New Jersey, 08903

United States

RWJBarnabas Health - Newark Beth Israel Medical Center

Newark, New Jersey, 07112

United States

RWJBarnabas Health - Robert Wood Johnson University Hospital

Somerset, New Jersey, 08873

United States

Collaborators and Investigators

Sponsor: Rutgers, The State University of New Jersey

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-09-19

Study Completion Date2027-03-01

Study Record Updates

Study Start Date2022-09-19

Study Completion Date2027-03-01

Terms related to this study

Additional Relevant MeSH Terms

Cardiac Toxicity
Early-stage Breast Cancer