Strain Imaging in Breast Cancer Patients Receiving Trastuzumab

NCT02080390 | Completed

• 1 other identifier: IRB201300763
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research study is to evaluate the effects of the chemotherapeutic drug, Trastuzumab (Herceptin) on the heart. Trastuzumab (Herceptin) is used to treat specific types of breast cancer and is known to cause weakening of the heart. Unfortunately, little is know as to why this this happens. The investigators want to identify any factors that may lead to the early detection, treatment and prevention of the cardiotoxicity (heart problem) associated with this drug.

Conditions

Her 2 Positive Breast Cancer

Keywords

Her 2 Positive Breast Cancer; Trastuzumab; Herceptin; Heart Failure; Echocardiography

Outcome Measures

Primary Outcomes (2)

• Longitudinal Strain

  Each transthoracic echocardiogram obtained during the patient's treatment will be assessed for longitudinal strain.

  Change in baseline longitudinal strain from beginning of study to end of study. Patients will be followed for a minimum of 1 year.

• Left Ventricular Ejection Fraction

  Left ventricular ejection fraction from all clinically indicated transthoracic echocardiograms will be compared from baseline through the end of the study.

  Change in ejection fraction from baseline to end of study. Patients will be followed for a minimum of 1 year.

Secondary Outcomes (2)

• Clinically evident congestive heart failure

  From baseline to end of study. Patients will be followed for a minimum of 1 year.

• Cardiac medication use

  Baseline to end of study. Patients will be follwed for a minimum of 1 year.

Study Arms (1)

Transthoracic echocardiogram (ultrasound)

Any transthoracic echocardiogram (ultrasound) of the heart, performed as part of standard clinical care, will be further evaluated for special parameters that may help to detect weakening.

Procedure: Transthoracic echocardiogram (ultrasound)

Interventions

Transthoracic echocardiogram (ultrasound) PROCEDURE

Any transthoracic echocardiogram (ultrasound) of the heart, performed as part of standard clinical care, will be further evaluated for special parameters that may help to detect weakening.

Also known as: Transthoracic echocardiogram

Transthoracic echocardiogram (ultrasound)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Women or men recieveing Trastuzumab (Herceptin) for HER2 positive breast cancer.

You may qualify if:

• Age greater than 18 years
• Her 2 positive breast cancer.
• Patients who are currently receiving Trastuzumab (Herceptin).
• Patients who received Trastuzumab (Herceptin) after the formation of the UFHealth Medical Plaza pharmacy database was initiated.

You may not qualify if:

• Age less than 18 years
• Patients who have not received Trastuzumab (Herceptin).
• Patients who received Trastuzumab prior to the formation of the UFHealth Medical Plaza pharmacy database.

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

Univerisity of Florida

Gainesville, Florida, 32610, United States

Location

MeSH Terms

Conditions

Heart Failure

Interventions

High-Energy Shock Waves

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Ultrasonic Waves; Sound; Radiation, Nonionizing; Radiation; Physical Phenomena

Study Officials

• Robert Hamburger, DO, MPH

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2014
• First Posted: March 6, 2014
• Study Start: September 1, 2014
• Primary Completion: October 28, 2016
• Study Completion: February 14, 2019
• Last Updated: March 1, 2019

Record last verified: 2019-02

Locations

US (1)