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Anthracycline

Simvastatin for Anthracycline-Related Cardiotoxicity

Phase 2
Waitlist Available
Led By Karen Smith, MD, MPH
Research Sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 18 years or older
Normal organ function and marrow function as defined by: Absolute neutrophil count (ANC) ≥ 1,000, Platelet count ≥ 100,000, Total bilirubin ≤ upper limit of normal, Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤1.5 times the upper limit of normal, Creatinine ≤1.5 times the upper limit of normal, Creatine kinase (CK) ≤2.5 times the upper limit of normal, Left ventricular ejection fraction (LVEF) as assessed by baseline echocardiogram at or above the lower limit of normal
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights

Study Summary

This trial is testing whether taking simvastatin while receiving doxorubicin will minimize heart damage caused by the anthracycline.

Who is the study for?
This trial is for women over 18 with stage I-III breast cancer who will receive doxorubicin chemotherapy. They must have normal organ and marrow function, not be pregnant, agree to use contraception, and have no history of heart disease or severe liver conditions. Women already on statins or certain other medications are excluded.Check my eligibility
What is being tested?
The study tests if simvastatin can prevent heart damage in women treated with the anthracycline drug doxorubicin for breast cancer. Participants will take simvastatin orally while undergoing their planned chemotherapy regimen.See study design
What are the potential side effects?
Simvastatin may cause muscle pain, weakness (myopathy), digestive issues, liver problems, and could interact with other drugs. Doxorubicin might lead to heart damage or weakening of the heart muscle.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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My blood counts and organ functions are within normal ranges.
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I am fully active or can carry out light work.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Echocardiographic Global Longitudinal Strain (GLS)
Secondary outcome measures
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Recurrence Free Survival (RFS) With Concurrent Simvastatin

Side effects data

From 2015 Phase 3 trial • 33 Patients • NCT02030041
11%
Myalgia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Vitamin D and Placebo
Simvastatin and Placebo
Simvastatin and Vitamin D

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: SimvastatinExperimental Treatment2 Interventions
Simvastatin will be administered on an outpatient basis orally at a dose of 40 mg once daily. Treatment will start 7 days prior to the planned doxorubicin/cyclophosphamide chemotherapy initiation and will continue for a total of 25 weeks.
Group II: No drugActive Control1 Intervention
Participant not randomized to simvastatin will participate in all aspects of the study, including planned doxorubicin/cyclophosphamide chemotherapy, with the exception of simvastatin administration.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Simvastatin
2012
Completed Phase 4
~1270

Find a Location

Who is running the clinical trial?

Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsLead Sponsor
557 Previous Clinical Trials
32,866 Total Patients Enrolled
43 Trials studying Breast Cancer
4,944 Patients Enrolled for Breast Cancer
Avon FoundationOTHER
13 Previous Clinical Trials
833 Total Patients Enrolled
7 Trials studying Breast Cancer
658 Patients Enrolled for Breast Cancer
Karen Smith, MD, MPHPrincipal InvestigatorSKCCC at Johns Hopkins

Media Library

Doxorubicin (Anthracycline) Clinical Trial Eligibility Overview. Trial Name: NCT02096588 — Phase 2
Breast Cancer Clinical Trial 2023: Doxorubicin Highlights & Side Effects. Trial Name: NCT02096588 — Phase 2
Doxorubicin (Anthracycline) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02096588 — Phase 2
Breast Cancer Research Study Groups: Simvastatin, No drug

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has Simvastatin received official authorization from the FDA?

"The current evidence of simvastatin's safety is sufficient to warrant a score of 2, as this drug has only completed the second trial phase without any data supporting its efficacy."

Answered by AI

What health conditions does Simvastatin commonly address?

"Simvastatin is a successful treatment option for patients with lung cancers, multiple sclerosis, and acute myelocytic leukemia."

Answered by AI

Is this an unprecedented investigation?

"Simvastatin's research journey began in 1997, when a Phase 1 trial sponsored by Alfacell was completed with 300 patients. After that initial study, Simvastatin received approval and has since become the subject of 983 active studies across 2370 cities and 71 countries."

Answered by AI

Is this experiment actively searching for participants?

"As indicated on clinicaltrials.gov, this medical trial is not seeking participants at the present time. The study was first posted in May 20th 2014 and last modified on May 19th 2022; however, there are currently 3600 other trials recruiting applicants for research."

Answered by AI

What other research endeavors have been undertaken utilizing Simvastatin?

"Initially trialled at Spectrum Health Hospital - Butterworth Campus in 1997, 1706 studies have since been completed regarding simvastatin. Currently, 983 live trials are taking place - notable concentrations of these research projects can be found around Baltimore, Maryland."

Answered by AI

What is the total enrollment for this trial?

"Unfortunately, this medical trial is not presently accepting new participants. It was first posted in May 2014 and its details were modified last on the 19th of May 2022. Nonetheless, there are 2,617 trials for breast cancer as well as 983 studies related to simvastatin that are currently recruiting patients."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Detection and Prevention of Anthracycline-Related Cardiac Toxicity With Concurrent Simvastatin
2014. "Detection and Prevention of Anthracycline-Related Cardiac Toxicity With Concurrent Simvastatin". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02096588.
~3 spots leftby Apr 2025
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