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A Prospective Study to See if Cardiac Effects of Herceptin Can be Prevented With Standard Heart Medications

Phase 1/Phase 2
18 Years
Open (Enrolling)
Breast Cancer, Heart Failure

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Trial Information

A Prospective Study to See if Cardiac Effects of Herceptin Can be Prevented With Standard Heart Medications

We propose a randomized, placebo-controlled, double-blind study evaluating the efficacy of
an ACE-inhibitor (perindopril) or a beta blocker (bisoprolol) for the prevention of LV
remodeling among women with early breast cancer scheduled for chemotherapy and one year of
trastuzumab. Participants will undergo cardiac MRI at baseline and 3 and 12 months,
replacing the usual MUGA, as well as a post-treatment cardiac MRI at 24 months to evaluate
long-term effect.

Inclusion Criteria:

- Histologic diagnosis of HER2 positive breast carcinoma

- Eligible to receive trastuzumab

- Age > 18 years

- Able to give informed consent

- No contraindications to MRI

Exclusion Criteria:

- Known contraindication to beta-blocker therapy

- Known contraindication to ACEI therapy

- Current treatment with ACEI or beta blocker for other indication

- History of heart failure, cardiomyopathy or baseline LVEF < 50%

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Caregiver, Investigator), Primary Purpose: Diagnostic

Outcome Measure:

The primary objective is to determine if conventional heart failure pharmacotherapy can prevent trastuzumab-mediated left ventricular (LV) remodeling among women with HER2+ early breast cancer.

Outcome Time Frame:

3.5 years

Safety Issue:


Principal Investigator

Ian Paterson, MD FRCPC

Investigator Role:

Principal Investigator

Investigator Affiliation:

Alberta Health Services


Canada: Health Canada

Study ID:

00027 / Ethics 25253



Start Date:

September 2010

Completion Date:

Related Keywords:

  • Breast Cancer
  • Heart Failure
  • trastuzumab
  • cardiac MRI
  • beta-blocker
  • biomarkers
  • angiotensin converting enzyme inhibitor
  • cardiotoxicity
  • HER2 positive
  • Breast Neoplasms
  • Heart Failure