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SCHOLAR

Official Title

Safety of Continuing Chemothrapy in Overt Left Ventricular Dysfunction using Antibodies to Human Epidermal Growth Factor Receptor-2

Status

Ongoing

Overview

Trastuzumab has been shown to improve survival in individuals with early stage HER-2 positive breast cancer. Injury to the heart is an important complication of trastuzumab therapy. we speculate that patients receiving trastuzumab despite the development of heart injury may still have chances of surviving breast cancer long-term by using heart failure therapies. The aim of the present study is therefore to determine the safety and tolerability of trastuzumab therapy for Stage I-III HER-2 positive breast cancer in patients with mild or moderate heart failure or LV dysfunction.

Study Design

Prospective modified phase I, non-randomized clinical study.

Primary Endpoint

The primary safety outcome will be the development of dose-limiting toxicity, defined as the occurrence of any of:

a). cardiovascular death, b). left ventricular ejection fraction (LVEF) <40% together with any heart failure symptoms, or c). LVEF <35%

The efficacy outcome will be the number of trastuzumab cycles completed after enrollment as a proportion of the originally planned number of trastuzumab cycles.

Number of Patients

20

Number of Sites

2

Number of Countries

1

Study Period

November2016 – November2018

Principal Investigator

Darryl Leong

Program Manager

Shirley Pettit

Research Coordinator

Yongning Ou