STOP Heart Disease in Breast Cancer Survivors Trial

NCT ID: NCT02674204

Last Updated: 2019-05-15

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-05-05
• Study Completion Date: 2018-05-25

Brief Summary

The purpose of this study is to to examine the effects of atorvastatin, a type of statin, on changes to the heart among women undergoing breast cancer treatment. Atorvastatin may reduce or eliminate the harmful effects of chemotherapy treatment to the heart tissue of breast cancer patients.

Detailed Description

This is a placebo-controlled study. It will compare the effects of atorvastatin against the effects of a placebo (an inactive substance, such as, a sugar pill) on changes to the heart before and during breast cancer treatment. Participants will be in the study for approximately a year and a half, and the study will enroll up to 60 patients. During that time, there will be six visits that may coincide with standard of care visits. Participants will also receive telephone calls from study staff during the study intervention and a follow-up phase to check-in with them.

Conditions

Breast Cancer; Heart Disease; Cardiotoxicity; Myocardial Dysfunction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Study Agent

One atorvastatin 20 mg oral capsule per day

Group Type: EXPERIMENTAL

Atorvastatin

Intervention Type: DRUG

Atorvastatin calcium, a synthetic lipid-lowering agent, is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, an early and rate-limiting step in cholesterol biosynthesis.

Control

One matching placebo daily

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

A substance that has no therapeutic effect, and will be used as a control in testing the study agent.

Interventions

Atorvastatin

Atorvastatin calcium, a synthetic lipid-lowering agent, is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, an early and rate-limiting step in cholesterol biosynthesis.

Intervention Type: DRUG

Placebo

A substance that has no therapeutic effect, and will be used as a control in testing the study agent.

Intervention Type: DRUG

Other Intervention Names

Lipitor; Atorvastatin calcium

Eligibility Criteria

Inclusion Criteria

• Female patients with newly diagnosed stage 1-3 breast cancer
• Histologically confirmed HER2, ER, and PR status
• Recommended to undergo trastuzumab treatment, with or without anthracycline. Patients will be eligible for up to 3 weeks after starting treatment.
• Age minimum 18 years
• Able and willing to read, understand, and sign an informed consent form (ICF) and medical release form
• Willing and able to comply with trial protocol and follow-up
• ECOG performance status 0-1 (Karnofsky ≥ 70%)

Exclusion Criteria

• Prior use of statin medication within the past year
• Not using statin medication but is eligible for statin therapy based on the 2013 ACC/AHA guidelines (LDL cholesterol >190, or LDL <190 and ASCVD risk >7.5%; http://tools.acc.org/ASCVD-Risk-Estimator/) and is > 50 years old; or is eligible for statin therapy based on the 2013 ACC/AHA guidelines and is 40-50 years old and wishes to be placed on statin therapy
• History of adverse effects, intolerance, or allergic reactions attributed to statin medication
• Current use of gemfibrozil, cyclosporine, clarithromycin, itraconazole, erythromycin, the hepatitis C protease inhibitor telaprevir, HIV protease inhibitors, colchicine, or red yeast rice
• Current use of any other investigational agent
• Pregnant or intention to get pregnant during the next 18 months. Pregnant women are excluded from this study because atorvastatin is a lipid-lowering agent with the potential for teratogenic or abortifacient effects, and MRI is contraindicated in pregnant women.
• History of diabetes, severe lung disease, renal disease (creatinine > 1.8 mg/dL or CrCl ≤ 50 mL/min), or hepatic disease (AST and ALT > 3 times upper normal limits)
• Abnormal baseline echocardiogram or cardiac MRI (detection of congenital heart disease; ischemic heart disease; moderate or severe valvular heart disease; cardiomyopathy; EF < 55%)
• Previously known or diagnosed heart disease (e.g. congenital; valvular; coronary artery disease; history of myocardial infarction or acute coronary syndrome; cardiomyopathy, including infiltrative, hypertensive, hypertrophic, dilated, constrictive pericarditis, or other cardiomyopathy)
• Left ventricular dysfunction (EF < 55%)
• Prior non-cardiac illness with an estimated life expectancy < 4 years
• Known active infection with HIV
• Allergy or contraindication to MRI testing, including claustrophobia, metallic parts in body the prohibiting MRI, prior gadolinium contrast reaction, or uncontrolled moderate hypertension (sitting blood pressure >160/95 mm Hg with measurements recorded on at least 2 occasions).
• Has metallic breast expanders in place at the time of screening
• Concurrent illness which in the opinion of the investigators would compromise either the patient or the integrity of the data

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

California Breast Cancer Research Program

OTHER

Sponsor Role: collaborator

Cedars-Sinai Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Marc Goodman

Professor and Director, Cancer Prevention & Control - Department, Cancer Institute

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Marc Goodman, PhD

Role: PRINCIPAL_INVESTIGATOR

Cedars-Sinal Medical Center

Locations

Cedars-Sinai Medical Center

Los Angeles, California, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

IIT2015-12-Goodman-STOP

Identifier Type: -

Identifier Source: org_study_id