Back to resultsA Feasibility Study for Women Receiving Anthracycline Chemotherapy With or Without Radiation for HER2-neu Positive Invasive Ductal Carcinoma (OTT14-01)
Primary Purpose
Breast Cancer
Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Feasibility study
Sponsored by
About this trial
This is an interventional other trial for Breast Cancer focused on measuring Invasive ductal, HER2-neu positive
Eligibility Criteria
Inclusion Criteria:
- Stage I-III, HER2-neu positive invasive ductal carcinoma
- Scheduled to receive adjuvant/neo-adjuvant 5-Fluorouracil, Epirubicin, Cyclophosphamide and Docetaxel (FEC-D) chemotherapy
- Scheduled to receive adjuvant Trastuzumab
- ECOG Performance status 0-2
- 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:
- Prior anthracycline chemotherapy
- History of dilated cardiomyopathy, congestive heart failure, or coronary artery disease
- Life expectancy less than 15 months
- Pregnant or lactating women
- Use of beta receptor antagonists, calcium channel antagonists, angiotensin converting enzyme inhibitors, or angiotensin receptor inhibitors at baseline.
- Previous chest wall/breast or nodal radiation.
Sites / Locations
- The Ottawa Hospital Cancer Centre
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Feasibility study
Arm Description
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.
Outcomes
Primary Outcome Measures
Recruitment rates
Secondary Outcome Measures
Cardiotoxicity
To measure biomarkers, myocardial perfusion, cardiac adverse events and peak systolic longitudinal strain.
Full Information
NCT ID
NCT02156648
First Posted
May 12, 2014
Last Updated
April 18, 2020
Sponsor
Ottawa Hospital Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT02156648
Brief Title
A Feasibility Study for Women Receiving Anthracycline Chemotherapy With or Without Radiation for HER2-neu Positive Invasive Ductal Carcinoma
Acronym
OTT14-01
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Unknown status
Study Start Date
August 2014 (undefined)
Primary Completion Date
July 2020 (Anticipated)
Study Completion Date
July 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ottawa Hospital Research Institute
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Invasive ductal, HER2-neu positive
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Feasibility study
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Feasibility study
Intervention Description
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.
Primary Outcome Measure Information:
Title
Recruitment rates
Time Frame
every 4 weeks up to 2 years
Secondary Outcome Measure Information:
Title
Cardiotoxicity
Description
To measure biomarkers, myocardial perfusion, cardiac adverse events and peak systolic longitudinal strain.
Time Frame
Once when the last participant completes week 57
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Stage I-III, HER2-neu positive invasive ductal carcinoma
Scheduled to receive adjuvant/neo-adjuvant 5-Fluorouracil, Epirubicin, Cyclophosphamide and Docetaxel (FEC-D) chemotherapy
Scheduled to receive adjuvant Trastuzumab
ECOG Performance status 0-2
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:
Prior anthracycline chemotherapy
History of dilated cardiomyopathy, congestive heart failure, or coronary artery disease
Life expectancy less than 15 months
Pregnant or lactating women
Use of beta receptor antagonists, calcium channel antagonists, angiotensin converting enzyme inhibitors, or angiotensin receptor inhibitors at baseline.
Previous chest wall/breast or nodal radiation.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susan Dent, Oncologist
Organizational Affiliation
The Ottawa Hospital Cancer Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Ottawa Hospital Cancer Centre
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
A Feasibility Study for Women Receiving Anthracycline Chemotherapy With or Without Radiation for HER2-neu Positive Invasive Ductal Carcinoma
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