Multidisciplinary Approach to Novel Therapies in Cardiology Oncology Research

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

99 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2016-09-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Breast Cancer Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Caregivers Investigators

Study Groups

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1

Group Type EXPERIMENTAL

perindopril OR bisoprolol OR placebo

Intervention Type DRUG

perindopril- oral daily titrated does from 2mg up to 8mg

bisoprolol- oral daily titrated dose from 2.5mg up to 10mg

Interventions

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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

Intervention Type DRUG

Eligibility Criteria

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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%

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No