STOP Heart Disease in Breast Cancer Survivors Trial (NCT02674204) | Clinical Trial Compass
TerminatedPhase 2
STOP Heart Disease in Breast Cancer Survivors Trial
Stopped: Closed due to low accrual
United States2 participantsStarted 2016-05-05
Plain-language 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.
Who can participate
Age range18 Years
SexFEMALE
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Inclusion Criteria:
* Female patients with newly diagnosed stage 1-3 breast cancer
* Histologically confirmed HER2, ER, and PR status
* Recommended to undergo trastuzumab treatment, with or without anthracycline. Patients will be eligible for up to 3 weeks after starting treatment.
* Age minimum 18 years
* Able and willing to read, understand, and sign an informed consent form (ICF) and medical release form
* Willing and able to comply with trial protocol and follow-up
* ECOG performance status 0-1 (Karnofsky ≥ 70%)
Exclusion Criteria:
* Prior use of statin medication within the past year
* Not using statin medication but is eligible for statin therapy based on the 2013 ACC/AHA guidelines (LDL cholesterol \>190, or LDL \<190 and ASCVD risk \>7.5%; http://tools.acc.org/ASCVD-Risk-Estimator/) and is \> 50 years old; or is eligible for statin therapy based on the 2013 ACC/AHA guidelines and is 40-50 years old and wishes to be placed on statin therapy
* History of adverse effects, intolerance, or allergic reactions attributed to statin medication
* Current use of gemfibrozil, cyclosporine, clarithromycin, itraconazole, erythromycin, the hepatitis C protease inhibitor telaprevir, HIV protease inhibitors, colchicine, or red yeast rice
* Current use of any other investigational agent
* Pregnant or intention to get pregnant during the next 18 months. Pregnant women are excluded from this study because atorvastatin is a lipid-lowering agent with the potential for teratogenic or abo…
What they're measuring
1
Change in Global Circumferential Strain (GCS) Measured by Cardiac MRI (CMRI)
Timeframe: baseline to 12 months post initiation of statin intervention