Strain Imaging in Breast Cancer Patients Receiving Trastuzumab

Her 2 Positive Breast Cancer Clinical Trial

Official title:

Strain Imaging in Breast Cancer Patients Receiving Trastuzumab

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02080390
• Other study ID #: IRB201300763
• Status: Completed
• Start date: September 2014
• Est. completion date: February 14, 2019

Study information

• Verified date: February 2019
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: February 14, 2019
• Est. primary completion date: October 28, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Neoplasms
• Her 2 Positive Breast Cancer

Intervention

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.

Locations

Country	Name	City	State
United States	Univerisity of Florida	Gainesville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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	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.
Secondary	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.