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

NCT02096588 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2024-07-09

Study results available
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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.

Conditions

  • Breast Cancer
  • Stage I Breast Cancer
  • Stage II Breast Cancer
  • Stage III Breast Cancer

Interventions

DRUG

Simvastatin

Simvastatin will be administered on an outpatient basis orally at a dose of 40 mg once daily.

DRUG

Doxorubicin/cyclophosphamide

The standard chemotherapy regimen that must be planned for all participants in order to take part in this study. The regimen is given every 2 or 3 weeks per standard of care, at the direction of the treating physician.

Sponsors & Collaborators

  • Avon Foundation

    collaborator OTHER

  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    lead OTHER

Principal Investigators

  • Karen Smith, MD, MPH · SKCCC at Johns Hopkins

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02096588 on ClinicalTrials.gov