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

Ottawa Hospital Research Institute

Status: Unknown

Conditions: Breast Cancer

Treatments: Other: Feasibility study

Study type: Interventional

Funder types: Other

Identifiers

NCT02156648

20140259-01H

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: Female

Ages: 19+ years old

Volunteers: No 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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

20 participants in 1 patient group

Feasibility study

Other group

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.

Treatment:

Other: Feasibility study