Study Type
Observational
completed
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%
Efficacy outcome:
The number of trastuzumab cycles completed after enrollment as a proportion of the originally planned number of trastuzumab cycles.
Study Design
Prospective modified phase I, non-randomized clinical study.
NO. of Countries
1
NO. of Sites
1
NO. of Participants
20
Study Period
2016-2019
Sponsor
PHRI
Darryl Leong
Senior Scientist
Darryl Leong
Senior Scientist
Leong’s clinical interests include cardio-oncology, frailty, multi-morbidity, and echocardiography. He is the Director of the McMaster University and Hamilton Health Sciences Cardio-Oncology Program. Leong graduated from the University of Adelaide Medical School with Deans Listing and Honours for academic excellence in 2000. He completed his cardiology training, Doctor of Philosophy, Master of Public Health, and Master of Biostatistics degrees at the University of Adelaide, Australia. He has completed a fellowship in cardiovascular imaging at the Leiden University Medical Centre, the Netherlands, before relocating to Canada.
Leong is an Associate Professor in the Division of Cardiology, Department of Medicine, at McMaster University and Hamilton Health Sciences. His research is supported by the Canadian Institutes of Health Research, Canadian Cancer Society, and the United States Department of Defense, among others. He has published approximately 200 manuscripts, including leading publications in the Lancet and New England Journal of Medicine as well as top cardiovascular journals. He is a Clinician Scientist of the Heart and Stroke Foundation of Canada and has received the Clive Kearon Mid-Career Award from McMaster University. Additionally, he serves as the Director of the Internal Medicine Resident Research Program and the Cardio-Oncology Program at McMaster University.
Sumathy Rangarajan
Program Director
Sumathy Rangarajan
Program Director
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.
Sarah Karampatos
Senior Research Coordinator
Sarah Karampatos
Senior Research Coordinator
Sarah Karampatos has been employed by Population Health Research Institute since 2017, working currently in the Global Health Department on the following cancer survivorship studies: RADICAL PC and ORCHID. She has experience working on large international investigator-initiated studies.
She holds a Masters of Science from McMaster University, Bachelor of Applied Science in Kinesiology from the University of Guelph and a Diploma in Fitness and Health Promotion from Humber College.
Hamilton Health Sciences
Heart and Stroke Foundation of Canada
Canadian Institutes of Health Research (CIHR)
Canadian Cancer Society
Novartis
ongoing
SCHOLAR 2
Cancer Survivorship
The objective of the SCHOLAR-2 study is to evaluate whether is it safe and effective...
