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 Type


Study Design

Prospective modified phase I, non-randomized clinical study.

NO. of Countries


NO. of Sites


NO. of Participants


Study Period




Hamilton Health Sciences

Heart and Stroke Foundation of Canada

Canadian Institutes of Health Research (CIHR)

Canadian Cancer Society


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