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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01016886
First Posted: November 20, 2009
Last Update Posted: February 9, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
AHS Cancer Control Alberta ( University of Alberta )
  Purpose
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.

Condition Intervention Phase
Breast Cancer Heart Failure Drug: perindopril OR bisoprolol OR placebo Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Care Provider, Investigator)
Primary Purpose: Diagnostic
Official Title: A Prospective Study to See if Cardiac Effects of Herceptin Can be Prevented With Standard Heart Medications

Resource links provided by NLM:


Further study details as provided by AHS Cancer Control Alberta ( University of Alberta ):

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. [ Time Frame: 3.5 years ]

Enrollment: 99
Study Start Date: September 2010
Estimated Study Completion Date: September 2016
Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: 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


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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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%
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01016886


Locations
Canada, Alberta
University of Alberta/ Cross Cancer Institute
Edmonton, Alberta, Canada
Sponsors and Collaborators
University of Alberta
Investigators
Principal Investigator: Ian Paterson, MD FRCPC Alberta Health Services
  More Information

Publications:
Haykowsky MJ, Mackey JR, Thompson B, Jones LW, Paterson DI. Adjuvant trastuzumab induces ventricular remodeling despite aerobic exercise training. Clin. Cancer Res.2009 Aug 1;15(15):4963-7. Mackey JR. Cardiac management during adjuvant trastuzumab therapy: recommendations of the Canadian Trastuzumab Working Group,et al.Current Oncology, Vol 15, No 1 (2008) Jones LW, Haykowsky MJ, Swatz JJ, Douglas PS, Mackey RJ.Early breast cancer therapy and cardiovascular injury.J Am Coll Cardiol. 2007 Oct9;50(15):1435-41. Epub 2007 Sep 24. Review.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Alberta
ClinicalTrials.gov Identifier: NCT01016886     History of Changes
Other Study ID Numbers: 00027 / Ethics 25253
First Submitted: November 18, 2009
First Posted: November 20, 2009
Last Update Posted: February 9, 2016
Last Verified: February 2016

Keywords provided by AHS Cancer Control Alberta ( University of Alberta ):
trastuzumab
cardiac MRI
beta-blocker
biomarkers
angiotensin converting enzyme inhibitor
cardiotoxicity
HER2 positive

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases
Bisoprolol
Perindopril
Angiotensin-Converting Enzyme Inhibitors
Antihypertensive Agents
Sympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic beta-1 Receptor Antagonists
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Protease Inhibitors
Enzyme Inhibitors