NCT02674204

STOP Heart Disease in Breast Cancer Survivors Trial

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Cedars-Sinai Medical Center · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

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

Timeline

• Start date: 2016-05-05
• Primary completion: 2018-05-25
• Completion: 2018-05-25
• First posted: 2016-02-04
• Last updated: 2019-05-15
• Results posted: 2019-04-30

Locations

1 site across 1 country: United States