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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
34
Simvastatin will be administered on an outpatient basis orally at a dose of 40 mg once daily.
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.
Kimmel Cancer Center at Johns Hopkins at Sibley Memorial Hospital
Washington D.C., District of Columbia, United States
Kimmel Cancer Center at Johns Hopkins
Baltimore, Maryland, United States
Change in Echocardiographic Global Longitudinal Strain (GLS)
To compare the absolute change in echocardiographic GLS (Global Longitudinal Strain) from baseline (T0) to 2-3 weeks after (T2) completion of 4 cycles of (neo)adjuvant anthracycline-based chemotherapy in early stage breast cancer patients who do and do not receive concurrent simvastatin therapy
Time frame: up to 15 weeks
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Number of participants with concurrent administration of simvastatin with (neo)adjuvant anthracycline-based chemotherapy in early stage breast cancer patients who experience adverse events as defined by NCI CTCAE v4.0.
Time frame: 52 weeks
Recurrence Free Survival (RFS) With Concurrent Simvastatin
To describe the recurrence free survival (RFS) in early stage breast cancer patients treated with anthracycline-based chemotherapy with and without concurrent simvastatin
Time frame: 5 years
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