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STOP Heart Disease in Breast Cancer Survivors Trial (STOP)

Primary Purpose

Breast Cancer, Heart Disease, Cardiotoxicity

Status

Terminated

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Atorvastatin

Placebo

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring Statin therapy, trastuzumab

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Cedars-Sinai Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Study Agent

Control

Arm Description

One atorvastatin 20 mg oral capsule per day

One matching placebo daily

Outcomes

Primary Outcome Measures

Change in Global Circumferential Strain (GCS) Measured by Cardiac MRI (CMRI)

Secondary Outcome Measures

Change in Global Longitudinal Strain as Measured by CMRI

Change in Peak Left Ventricular Twist as Measured by CMRI

Change in Peak Left Ventricular Torsion as Measured by CMRI

Change in Left Ventricular Untwisting Rate as Measured by CMRI

Change in Left Ventricular Ejection Fraction as Measured by CMRI

Change in Left Ventricular End Diastolic Volume as Measured by CMRI

Change in Left Ventricular End Systolic Volume as Measured by CMRI

Change in Cardiac Output as Measured by CMRI

Change in Left Ventricular Mass as Measured by CMRI

Change in Left Ventricular Concentricity as Measured by CMRI

Change in Native T1 as Measured by CMRI

Change in Post Contrast T1 as Measured by CMRI

Change in Extracellular Volume as Measured by CMRI

Change in Native T2 as Measured by CMRI

Full Information

NCT ID

NCT02674204

First Posted

January 21, 2016

Last Updated

May 1, 2019

Sponsor

Cedars-Sinai Medical Center

Collaborators

California Breast Cancer Research Program

1. Study Identification

Unique Protocol Identification Number

NCT02674204

Brief Title

STOP Heart Disease in Breast Cancer Survivors Trial

Acronym

STOP

Official Title

Statin Therapy Operates to Prevent (STOP) Heart Disease in Breast Cancer Survivors Trial

Study Type

Interventional

2. Study Status

Record Verification Date

May 2019

Overall Recruitment Status

Terminated

Why Stopped

Closed due to low accrual

Study Start Date

May 5, 2016 (Actual)

Primary Completion Date

May 25, 2018 (Actual)

Study Completion Date

May 25, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Cedars-Sinai Medical Center

Collaborators

California Breast Cancer Research Program

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer, Heart Disease, Cardiotoxicity, Myocardial Dysfunction

Keywords

Statin therapy, trastuzumab

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

2 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Study Agent

Arm Type

Experimental

Arm Description

One atorvastatin 20 mg oral capsule per day

Arm Title

Control

Arm Type

Placebo Comparator

Arm Description

One matching placebo daily

Intervention Type

Drug

Intervention Name(s)

Atorvastatin

Other Intervention Name(s)

Lipitor, Atorvastatin calcium

Intervention Description

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

Intervention Name(s)

Placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

Change in Global Circumferential Strain (GCS) Measured by Cardiac MRI (CMRI)

Time Frame

baseline to 12 months post initiation of statin intervention

Secondary Outcome Measure Information:

Title

Change in Global Longitudinal Strain as Measured by CMRI

Time Frame