This trial is active, not recruiting.

Conditions breast cancer, heart failure
Treatment perindopril or bisoprolol or placebo
Phase phase 1/phase 2
Sponsor University of Alberta
Start date September 2010
End date September 2015
Trial size 99 participants
Trial identifier NCT01016886, 00027 / Ethics 25253


While trastuzumab has been shown to prevent recurrences of breast cancer, some women may also experience damage to their heart muscle (including heart failure) as a result of their treatment. The investigators hope to learn if standard medications used in heart failure can prevent heart damage caused by trastuzumab in women with breast cancer. The investigators would also like to know if there are any ways to detect this damage earlier using magnetic resonance imaging (MRI) and blood tests.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model single group assignment
Masking double blind (caregiver, investigator)
Primary purpose diagnostic
perindopril or bisoprolol or placebo
perindopril- oral daily titrated does from 2mg up to 8mg bisoprolol- oral daily titrated dose from 2.5mg up to 10mg

Primary Outcomes

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.
time frame: 3.5 years

Eligibility Criteria

Female participants at least 18 years old.

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%

Additional Information

Official title A Prospective Study to See if Cardiac Effects of Herceptin Can be Prevented With Standard Heart Medications
Principal investigator Ian Paterson, MD FRCPC
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by AHS Cancer Control Alberta.