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

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02156648

Acronym

OTT14-01

Enrollment

Registered

2014-06-05

Start date

2014-08-31

Completion date

2020-07-31

Last updated

2020-04-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

Invasive ductal, HER2-neu positive

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.

Interventions

OTHERFeasibility 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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

19 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Recruitment rates	every 4 weeks up to 2 years

Secondary

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

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026