Safety of Continuing CHemotherapy in Overt Left Ventricular Dysfunction Using Antibodies to HER-2

• Status: Completed
• Trial end date: 2018-04-12
• Target enrollment: 0
• Participant gender: All

Summary

Trastuzumab is an important treatment for HER 2 positive breast cancer. But trastuzumab can cause injury to the heart, and this is one of the main reasons it cannot be administered as planned. Heart injury can often be successfully treated using cardiac medications. The aim of SCHOLAR is to evaluate whether it is safe to continue trastuzumab in individuals with mild or moderate cardiac injury, while treating them with appropriate cardiac medications. In this way the investigators hope to be able to optimise the delivery of a treatment to patients with breast cancer that has proven survival benefits, especially when administered for a full 12-month course.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Population Health Research Institute
• Treatments: Adrenergic beta-Antagonists

Criteria

Inclusion Criteria:

• Stage I-III HER-2 positive breast cancer

• Receiving adjuvant therapy with trastuzumab

• Provide informed consent

• Exhibit LV dysfunction as evidenced by either

• LVEF between 40% and the lower limit for normal (i.e. <54% in women or < 52% in men18), or

• LVEF within normal limits (i.e. ≥54% in women or ≥52% in men) and NYHA class II heart failure symptoms within the past year, or

• A fall in LVEF of ≥15% from baseline

Exclusion Criteria:

Patients will not be eligible for SCHOLAR if they have any of the following:

• NYHA class III or IV heart failure

• Systolic blood pressure <90mmHg

• Current use of both ACE-I/angiotensin receptor blocker and beta-blocker

• Contra-indication to both ACE-I/angiotensin receptor blocker and beta-blocker