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Multidisciplinary Approach to Novel Therapies in Cardiology Oncology Research (MANTICORE)

Primary Purpose

Breast Cancer, Heart Failure

Status
Unknown status
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
perindopril OR bisoprolol OR placebo
Sponsored by
University of Alberta
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Breast Cancer focused on measuring trastuzumab, cardiac MRI, beta-blocker, biomarkers, angiotensin converting enzyme inhibitor, cardiotoxicity, HER2 positive

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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%

Sites / Locations

  • University of Alberta/ Cross Cancer Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
November 18, 2009
Last Updated
February 8, 2016
Sponsor
University of Alberta
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1. Study Identification

Unique Protocol Identification Number
NCT01016886
Brief Title
Multidisciplinary Approach to Novel Therapies in Cardiology Oncology Research
Acronym
MANTICORE
Official Title
A Prospective Study to See if Cardiac Effects of Herceptin Can be Prevented With Standard Heart Medications
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Unknown status
Study Start Date
September 2010 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
September 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Alberta

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Heart Failure
Keywords
trastuzumab, cardiac MRI, beta-blocker, biomarkers, angiotensin converting enzyme inhibitor, cardiotoxicity, HER2 positive

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
Care ProviderInvestigator
Allocation
Randomized
Enrollment
99 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
perindopril OR bisoprolol OR placebo
Intervention Description
perindopril- oral daily titrated does from 2mg up to 8mg bisoprolol- oral daily titrated dose from 2.5mg up to 10mg
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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%
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ian Paterson, MD FRCPC
Organizational Affiliation
Alberta Health services
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alberta/ Cross Cancer Institute
City
Edmonton
State/Province
Alberta
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
19622583
Citation
Haykowsky MJ, Mackey JR, Thompson RB, Jones LW, Paterson DI. Adjuvant trastuzumab induces ventricular remodeling despite aerobic exercise training. Clin Cancer Res. 2009 Aug 1;15(15):4963-7. doi: 10.1158/1078-0432.CCR-09-0628. Epub 2009 Jul 21.
Results Reference
background
PubMed Identifier
21794114
Citation
Pituskin E, Haykowsky M, Mackey JR, Thompson RB, Ezekowitz J, Koshman S, Oudit G, Chow K, Pagano JJ, Paterson I. Rationale and design of the Multidisciplinary Approach to Novel Therapies in Cardiology Oncology Research Trial (MANTICORE 101--Breast): a randomized, placebo-controlled trial to determine if conventional heart failure pharmacotherapy can prevent trastuzumab-mediated left ventricular remodeling among patients with HER2+ early breast cancer using cardiac MRI. BMC Cancer. 2011 Jul 27;11:318. doi: 10.1186/1471-2407-11-318.
Results Reference
derived

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Multidisciplinary Approach to Novel Therapies in Cardiology Oncology Research

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