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.
Primary safety outcome:
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 number of trastuzumab cycles completed after enrollment as a proportion of the originally planned number of trastuzumab cycles.
Prospective modified phase I, non-randomized clinical study.
Darryl Leong is a Scientist at PHRI, Director of the McMaster University and Hamilton Health Sciences Cardio-Oncology Program, Associate Professor, Department of Medicine (Cardiology), McMaster University, and Staff Cardiologist at Hamilton Health Sciences. He has methodological expertise in clinical epidemiology and clinical trials, and content expertise in physical frailty, echocardiography, and cardio-oncology. His research is supported by the CIHR, and he has published more than 100 manuscripts including all the leading internal medical and cardiovascular journals.
He graduated from the University of Adelaide Medical School with Deans Listing and Honours for academic excellence, completed his cardiology training, Doctor of Philosophy, Master of Public Health, and Master of Biostatistics degrees at the University of Adelaide in Australia, and completed a post-doctorate fellowship in cardiovascular imaging at the Leiden University Medical Centre in The Netherlands, before re-locating to Canada.
Sumathy Rangarajan has been Program Director, Global Health, since 2016, preceded by many years’ service at PHRI in other roles. She oversees the PURE study team, as well as the INVICTUS rheumatic AF treatment trial, the CANPWR pediatric weight management registry, and others.
She holds both a Bachelor of Science Degree and a Master of Science degree from Pune University in India.
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