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

Not Applicable

• Conditions: Breast Cancer
• Interventions: Other: Feasibility study

• Registration Number: NCT02156648
• Lead Sponsor: Ottawa Hospital Research Institute

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 Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2014-05-12
• Study First Submitted QC: 2014-05-30
• Study First Posted: 2014-06-05
• Study Start: 2014-08
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-18
• Last Update Posted: 2020-04-21
• Primary Completion: 2020-07
• Study Completion: 2020-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 20

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Feasibility study	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.

Primary Outcome Measures

Name	Time	Method
Recruitment rates	every 4 weeks up to 2 years

Secondary Outcome Measures

Name	Time	Method
Cardiotoxicity	Once when the last participant completes week 57	To measure biomarkers, myocardial perfusion, cardiac adverse events and peak systolic longitudinal strain.

Trial Locations

Locations (1)

The Ottawa Hospital Cancer Centre; 🇨🇦 Ottawa, Ontario, Canada