A Feasibility Study for Women Receiving Anthracycline Chemotherapy With or Without Radiation for HER2-neu Positive Invasive Ductal Carcinoma (OTT14-01)

April 18, 2020 updated by: Ottawa Hospital Research Institute

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Ottawa, Ontario, Canada, K1H 8L6
        • The Ottawa Hospital Cancer Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. Stage I-III, HER2-neu positive invasive ductal carcinoma
  2. Scheduled to receive adjuvant/neo-adjuvant 5-Fluorouracil, Epirubicin, Cyclophosphamide and Docetaxel (FEC-D) chemotherapy
  3. Scheduled to receive adjuvant Trastuzumab
  4. ECOG Performance status 0-2
  5. Adequate baseline imaging on transthoracic echocardiography, and baseline cardiac ejection fraction of ≥ 55%. Additionally, breast cancer patients≥45 years of age and scheduled to receive whole breast radiation therapy will receive two cardiac PET scans.

Exclusion Criteria:

  1. Prior anthracycline chemotherapy
  2. History of dilated cardiomyopathy, congestive heart failure, or coronary artery disease
  3. Life expectancy less than 15 months
  4. Pregnant or lactating women
  5. Use of beta receptor antagonists, calcium channel antagonists, angiotensin converting enzyme inhibitors, or angiotensin receptor inhibitors at baseline.
  6. Previous chest wall/breast or nodal radiation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Feasibility study
All participants will have blood draws for biomarkers during the course of the study at visit 1, 2, 3, 4, 5, 6, 7 and 8. they will also have the speckle tracking echocardiogram at visit 1, 4, 5, 6, 7 and 8. For women 45 an over a cardiac PET scan will be performed at visit 1 and 5.
Other: Feasibility study
All participants will have blood draws for biomarkers during the course of the study at visit 1, 2, 3, 4, 5, 6, 7 and 8. they will also have the speckle tracking echocardiogram at visit 1, 4, 5, 6, 7 and 8. For women 45 an over a cardiac PET scan will be performed at visit 1 and 5.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Recruitment rates
Time Frame: every 4 weeks up to 2 years
every 4 weeks up to 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cardiotoxicity
Time Frame: Once when the last participant completes week 57
To measure biomarkers, myocardial perfusion, cardiac adverse events and peak systolic longitudinal strain.
Once when the last participant completes week 57

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ottawa Hospital Research Institute

Investigators

  • Principal Investigator: Susan Dent, Oncologist, The Ottawa Hospital Cancer Centre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2014

Primary Completion (Anticipated)

July 1, 2020

Study Completion (Anticipated)

July 1, 2020

Study Registration Dates

First Submitted

May 12, 2014

First Submitted That Met QC Criteria

May 30, 2014

First Posted (Estimate)

June 5, 2014

Study Record Updates

Last Update Posted (Actual)

April 21, 2020

Last Update Submitted That Met QC Criteria

April 18, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20140259-01H

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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