Multidisciplinary Approach to Novel Therapies in Cardiology Oncology Research

Breast Cancer Clinical Trial

— MANTICORE  

Official title:

A Prospective Study to See if Cardiac Effects of Herceptin Can be Prevented With Standard Heart Medications

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01016886
• Other study ID #: 00027 / Ethics 25253
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• First received: November 18, 2009
• Last updated: February 8, 2016
• Start date: September 2010
• Est. completion date: September 2016

Study information

• Verified date: February 2016
• Source: AHS Cancer Control Alberta
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 99
• Est. completion date: September 2016
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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%

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Caregiver, Investigator), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Breast Cancer
• Heart Failure

Intervention

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

Locations

Country	Name	City	State
Canada	University of Alberta/ Cross Cancer Institute	Edmonton	Alberta

Sponsors (1)

Lead Sponsor	Collaborator
University of Alberta

Country where clinical trial is conducted

Canada, 

References & Publications (1)

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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		3.5 years	No