Lisinopril or Coreg CR(r) in Reducing Side Effects in Women With Breast Cancer Receiving Trastuzumab

The SunCoast CCOP Research Base is currently conducting a randomized, placebo controlled phase II study of lisinopril and extended-release carvedilol phosphate for the reduction of trastuzumab-induced cardiotoxicity in breast cancer patients receiving trastuzumab. The end point for this trial is a reduction in left ventricular ejection fraction (LVEF), a commonly used marker of cardiotoxicity. By design, those enrolled in this study are treated in multiple community settings and the echocardiograms are read locally. This gives rise to sonographer/cardiologist variability in LVEF readings. Recently there has been an attempt to address this variability by the development of standards for core laboratories. This proposal seeks to gather the individual echocardiograms and have them read centrally: 1) To obtain a broader, enlarged set of cardiac measurements (such as strain rate) to identify those measurements, individually or in combination which are predictive of LVEF changes; 2) To validate the findings in aim 1 using echocardiograms from the PREDICT or other DCP funded studies; 3) To evaluate the difference between multiple community operator readings and that of a central core; 4) To restate the clinical outcome of the current trial using an end point based upon a central review.