Multidisciplinary Approach to Novel Therapies in Cardiology Oncology Research

Phase 1

• Conditions: Breast Cancer; Heart Failure
• Interventions: Drug: perindopril OR bisoprolol OR placebo

• Registration Number: NCT01016886
• Lead Sponsor: University of Alberta

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2009-11-18
• Study First Submitted QC: 2009-11-19
• Study First Posted: 2009-11-20
• Study Start: 2010-09
• Primary Completion: 2015-09
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-08
• Last Update Posted: 2016-02-09
• Study Completion: 2016-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 99

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%

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	perindopril OR bisoprolol OR placebo	-

Primary Outcome Measures

Name	Time	Method
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.	3.5 years

Trial Locations

Locations (1)

University of Alberta/ Cross Cancer Institute; 🇨🇦 Edmonton, Alberta, Canada