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

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. Identifier: NCT01016886
Recruitment Status : Unknown
Verified February 2016 by AHS Cancer Control Alberta ( University of Alberta ).
Recruitment status was:  Active, not recruiting
First Posted : November 20, 2009
Last Update Posted : February 9, 2016
Information provided by (Responsible Party):
AHS Cancer Control Alberta ( 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.

Condition or disease Intervention/treatment Phase
Breast Cancer Heart Failure Drug: perindopril OR bisoprolol OR placebo Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 99 participants
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
Study Start Date : September 2010
Actual Primary Completion Date : September 2015
Estimated Study Completion Date : September 2016

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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%

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 identifier (NCT number): NCT01016886

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

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 Identifier (NCT Number):
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Responsible Party: University of Alberta Identifier: NCT01016886     History of Changes
Other Study ID Numbers: 00027 / Ethics 25253
First Posted: November 20, 2009    Key Record Dates
Last Update Posted: February 9, 2016
Last Verified: February 2016
Keywords provided by AHS Cancer Control Alberta ( University of Alberta ):
cardiac MRI
angiotensin converting enzyme inhibitor
HER2 positive
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases
Antihypertensive Agents
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
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors