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- Safety of Continuing HER-2 Directed Therapy in Overt Left Ventricular Dysfunction: A Randomized, Controlled Trial (SCHOLAR-2)
Clinical Trial
Safety of Continuing HER-2 Directed Therapy in Overt Left Ventricular Dysfunction: A Randomized, Controlled Trial (SCHOLAR-2)
The purpose of this study is to evaluate whether is it safe and effective to continue trastuzumab, pertuzumab, or trastuzumab-emtansine (T-DM1) in patients with early stage HER-2 positive breast cancer who develop mild, minimally symptomatic or asymptomatic systolic left ventricular dysfunction. There will be up to 20 participants enrolled at Augusta University with a total of 130 at all sites.
Eligibility Criteria
- Inclusion: · Stage I-III HER-2 positive breast cancer Receiving adjuvant or neoadjuvant therapy with trastuzumab, pertuzumab, or trastuzumab-emtansine (T-DM1) Evidence of left ventricular dysfunction, as defined by at least one of a) LVEF < 54% or b) LVEF ?54% and either i. Fall in LVEF of ?15% from prior to trastuzumab, pertuzumab, or trastuzumab-emtansine (T-DM1) exposure, or ii. New York Heart Association (NYHA) class II heart failure symptoms within the past 6 months Exclusion: · Current use of both angiotensin converting enzyme inhibitor (ACE-I) /angiotensin receptor blocker (ARB) and beta-blocker · < 18 years of age · Systolic blood pressure <100mmHg
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