Strain Imaging in Breast Cancer Patients Receiving Trastuzumab

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.

Study Overview

• Status: Completed
• Conditions: Her 2 Positive Breast Cancer
• Intervention / Treatment: Procedure: Transthoracic echocardiogram (ultrasound)

Detailed Description

As a subject participating in this study the following information will be collected: complete past medical history including age, height, and weight will be done with each echocardiogram; blood pressure at clinic visits during treatment with trastuzumab, type of cancer will be noted, type of chemotherapy, doses of chemotherapy, type and dose of chemotherapy in the past, type and dose of radiation therapy received, names and doses of cardiac medications, results of cardiac tests, results of lab tests, family history of heart disease, and social history which will include risk factors for developing heart disease including tobacco and alcohol use. This information will be entered into a database for the investigators to try and detect any factors that may lead to the cardiotoxicity (heart problem) that may be caused by Trastuzumab (Herceptin).

Any transthoracic echocardiogram (heart ultrasound) ordered will be further evaluated for special parameters that may help to detect weakening of the heart earlier than a normal ultrasound. An echocardiogram (heart ultrasound) is when a probe is placed on the chest and pictures are taken using sound waves and a special camera.

• Study Type: Observational
• Enrollment (Actual): 25

Contacts and Locations

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32610
      • Univerisity of Florida

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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); 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.; Other Names: Transthoracic echocardiogram

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinically evident congestive heart failure	Clinically evident congestive heart failure(symptoms of fluid overload such as shortness of breath, dyspnea on exertion, orthopnea or paroxysmal nocturnal dyspnea or physical findings of congestive heart failure such as jugular venous distension, rales on pulmonary exam, lower extremity edema).	From baseline to end of study. Patients will be followed for a minimum of 1 year.
Cardiac medication use	The type and dose of all cardiac medications will be followed from baseline to end of study.	Baseline to end of study. Patients will be follwed for a minimum of 1 year.

Collaborators and Investigators

• Sponsor: University of Florida
• Investigators: Principal Investigator: Robert Hamburger, DO, MPH, University of Florida

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (ACTUAL): October 28, 2016
• Study Completion (ACTUAL): February 14, 2019

Study Registration Dates

• First Submitted: February 27, 2014
• First Submitted That Met QC Criteria: March 4, 2014
• First Posted (ESTIMATE): March 6, 2014

Study Record Updates

• Last Update Posted (ACTUAL): March 1, 2019
• Last Update Submitted That Met QC Criteria: February 28, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: Heart Failure; Echocardiography; Trastuzumab; Herceptin; Her 2 Positive Breast Cancer
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: IRB201300763