Statins for Reduction of Cardiac Toxicity in Patients Receiving HER2 Targeted

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-19

Study Completion Date

2027-03-01

Brief Summary

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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.

Detailed Description

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A single arm open-label phase 2 study to evaluate the cardioprotective effects of statins in patients with Stage I-III HER2 positive breast cancer receiving HER2 targeted therapy. This study will evaluate the hypothesis that addition of statins will reduce treatment delays/discontinuations related to symptomatic/asymptomatic cardiac dysfunction in patients being treated with anti-HER2 therapy. The long-term goal of this study is to improve disease related outcomes and quality of life measures in patients being treated with anti-HER2 therapy.

Conditions

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Cardiac Toxicity Early-stage Breast Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Stage I-III HER2positive breast cancer receiving anti-HER2 therapy. Participants will receive Lipitor 40 mg PO daily.

Anti-HER2 targeted therapy + Lipitor 40mg daily

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Anti-HER2 targeted therapy + Lipitor 40mg daily

Participants will receive Lipitor 40 mg PO daily while receiving anti-HER2 therapy.

Group Type EXPERIMENTAL

Lipitor 40mg Tablet

Intervention Type DRUG

LIPITOR® (atorvastatin calcium) tablets will be administered orally as a single dose of 40 mg once daily, with or without food

Interventions

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Lipitor 40mg Tablet

LIPITOR® (atorvastatin calcium) tablets will be administered orally as a single dose of 40 mg once daily, with or without food

Intervention Type DRUG

Other Intervention Names

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Atorvastatin Calcium

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Responsible Party

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Mridula George, MD

Assistant Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mridula George, MD

Role: PRINCIPAL_INVESTIGATOR

Rutgers Cancer Institute of New Jersey

Identifier Type: OTHER

Identifier Source: secondary_id

042201

Identifier Type: -

Identifier Source: org_study_id

Statins for Reduction of Cardiac Toxicity in Patients Receiving HER2 Targeted

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Study Design

Study Groups

Anti-HER2 targeted therapy + Lipitor 40mg daily

Lipitor 40mg Tablet

Interventions

Lipitor 40mg Tablet

Other Intervention Names

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

Rutgers, The State University of New Jersey

Responsible Party

Mridula George, MD

Principal Investigators

Mridula George, MD

Locations

Trinitas Hospital and Comprehensive Cancer Center

RWJBarnabas Health - Robert Wood Johnson University Hospital, Hamilton

RWJBarnabas Health - - Jersey City Medical Medical

Monmouth Medical Center Southern Campus

RWJBarnabas Health - Monmouth Medical Center

Monmouth Community Medical

Rutgers Cancer Institute of New Jersey

RWJBarnabas Health - Robert Wood Johnson University Hospital

RWJBarnabas Health - Newark Beth Israel Medical Center

RWJBarnabas Health - Robert Wood Johnson University Hospital

Countries

Central Contacts

Mridula George, MD

Coral Omene, MD

Facility Contacts

Mridula George, MD

Mridula George, MD

mridula George, MD

Mridula George, MD

Mridula George, MD

Mridula George, MD

Mridula George, MD

Mridula George, MD

Mridula George, MD

Mridula George, MD

Other Identifiers

Pro2022000290

042201