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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by AHS Cancer Control Alberta
Sponsor:
Information provided by (Responsible Party):
AHS Cancer Control Alberta ( University of Alberta )
ClinicalTrials.gov Identifier:
NCT01016886
First received: November 18, 2009
Last updated: June 10, 2014
Last verified: June 2014
  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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Caregiver, 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:

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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 159
Study Start Date: September 2010
Estimated Primary Completion Date: September 2014 (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

Ages Eligible for Study:   18 Years and older
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01016886

Contacts
Contact: Edith Pituskin, RN MN 780-432-8792 pituskin@ualberta.ca

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

No publications provided by AHS Cancer Control Alberta

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: AHS Cancer Control Alberta ( University of Alberta )
ClinicalTrials.gov Identifier: NCT01016886     History of Changes
Other Study ID Numbers: 00027 / Ethics 25253
Study First Received: November 18, 2009
Last Updated: June 10, 2014
Health Authority: Canada: Health Canada

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

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

ClinicalTrials.gov processed this record on November 20, 2014