Clinical Trial: A Feasibility Study for Women Receiving Anthracycline Chemotherapy With or Without Radiation for HER2-neu Positive Invasive Ductal Carcinoma

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: A Feasibility Study for Women Receiving Adjuvant or Neo-adjuvant Anthracycline Chemotherapy With or Without Radiation for HER2-neu Positive Invasive Ductal Carcinoma

Brief Summary: The purpose of this project is to assess the feasibility of collecting plasma samples for cardiac biomarker assessment, and to identify if there is an associations between the biomarkers, echocardiographic features and the cardiac PET scan results (in patients receiving radiation therapy). This is the first step in a research program that has an overall goal of being able to predict early-treatment induced cardiotoxicity in patients with breast cancer.

Detailed Summary:
Sponsor: Ottawa Hospital Research Institute

Current Primary Outcome: Recruitment rates [ Time Frame: every 4 weeks up to 2 years ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Cardiotoxicity [ Time Frame: Once when the last participant completes week 57 ]

To measure biomarkers, myocardial perfusion, cardiac adverse events and peak systolic longitudinal strain.


Original Secondary Outcome: Same as current

Information By: Ottawa Hospital Research Institute

Dates:
Date Received: May 12, 2014
Date Started: August 2014
Date Completion: December 2017
Last Updated: January 27, 2017
Last Verified: January 2017