Recruiting

Echocardiography

Sponsor:

Stony Brook University

Code:

NCT03155802

Conditions

Cardiotoxicity

Heart Failure

Breast Cancer

Anthracycline Induced Cardiomyopathy

Biomarkers

Eligibility Criteria

Sex: Female

Age: 18 - 70+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

This is a pilot prospective cohort study, in adult female subjects 18-85 years old with a diagnosis of invasive breast cancer who are planned for anthracycline-inclusive chemotherapy and followed up for a time period of 6 months post completion of anthracycline chemotherapy. They will participate in blood and imaging tests with a goal of determining the best method for predicting the occurrence of cardiotoxicity in this subpopulation.

Conditions

Cardiotoxicity

Heart Failure

Breast Cancer

Anthracycline Induced Cardiomyopathy

Biomarkers

Study ID

NCT03155802

Start date

Apr 18, 2017

Status verified date

Oct, 2019

Completion date

Dec, 2020

Anticipated

Primary completion date

Dec, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Female subjects aged 18-85 years old
2. Biopsy-proven diagnosis of invasive breast cancer carcinoma
3. Plan for anthracycline inclusive chemotherapy (+/- taxanes, +/- trastuzumab)

Exclusion Criteria:

1. History of major heart disease at the time of breast cancer diagnosis (myocardial infarction or known left ventricular dysfunction (LVD) at baseline (defined as ejection fraction <40%)
2. History of known obstructive coronary artery disease (CAD), or coronary revascularization within the past 1 year
3. History of clinical heart failure or previous heart failure hospitalization
4. Patients with elevations in NT-pro BNP (above 3x ULN), or ST2 (above 2x ULN), galectin-3 (above 2x ULN), or hs troponin (above 2x ULN) during baseline screening
5. Patients with metastatic disease or recurrent breast cancer at diagnosis
6. History of other chemotherapy treated malignancy

Study Design

Enrollment

35 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Association of Heart Failure Biomarkers with Global Longitudinal strain rate [ Time Frame: up to 35 weeks ]

Central Contacts and Locations

Central contacts

Michelle Bloom, MD

6314442031michelle.bloom@stonybrookmedicine.edu

Indre Caikauskaite

6314442031indre.caikauskaite@stonybrookmedicine.edu

Locations

Stony Brook Medicine

Recruiting

Stony Brook, New York, United States, 11738

Contacts

Michelle Bloom, MD

631-444-2031michelle.bloom@stonybrookmedicine.edu

More Information

Sponsor

Stony Brook University

Last update posted

Nov 1, 2019

Last verified

Oct, 2019

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Stony Brook University on 2019-11-01.