drugset / Trial / NCT02096588

Detection and Prevention of Anthracycline-Related Cardiac Toxicity With Concurrent Simvastatin

NCT02096588

RandomizedParallel-groupOpen-labelTreatment

Summary

Doxorubicin (Adriamycin), one of the drugs commonly used for the treatment of breast cancer, is in a class of medications called anthracyclines. Anthracyclines may cause heart damage that can lead to weakening of the heart muscle. This heart damage may happen right away or may occur many years after the anthracycline is given Simvastatin is an oral medication approved by the FDA to lower cholesterol. Simvastatin is in a class of medications called statins. Some research has shown that statins may prevent heart damage that can be caused by anthracyclines like Doxorubicin (Adriamycin). The purpose of this study is to determine if taking simvastatin while receiving the chemotherapy Doxorubicin (Adriamycin) will minimize damage to the heart. This study is for women who will be receiving the anthracycline doxorubicin (Adriamycin) as part of their breast cancer treatment.

Timeline

Start
2014-05-20
Primary completion
2017-04-25
Completion
2023-07-26

Drugs

EvaluationDrugModalityDoseRoute
Subject Simvastatin Small molecule 40 mg Oral
Background Cyclophosphamide Other / unclassified
Background Doxorubicin Other / unclassified

Indications