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

Breast Cancer Clinical Trial

— 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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02156648
• Other study ID #: 20140259-01H
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 2014
• Est. completion date: July 2020

Study information

• Verified date: April 2020
• Source: Ottawa Hospital Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: July 2020
• Est. primary completion date: July 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 19 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Carcinoma, Ductal

Intervention

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.

Locations

Country	Name	City	State
Canada	The Ottawa Hospital Cancer Centre	Ottawa	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Ottawa Hospital Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recruitment rates		every 4 weeks up to 2 years
Secondary	Cardiotoxicity	To measure biomarkers, myocardial perfusion, cardiac adverse events and peak systolic longitudinal strain.	Once when the last participant completes week 57