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Completed

NCT Number: NCT02080390

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.

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Key information

Conditions

Her 2 Positive Breast Cancer Cardiovascular Diseases Heart Diseases Heart Failure

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Univerisity of Florida

Gainesville, Florida, 32610, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: Transthoracic echocardiogram

Primary outcomes

  1. Longitudinal Strain

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

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

  2. Left Ventricular Ejection Fraction

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

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

Secondary outcomes

  1. Clinically evident congestive heart failure

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

    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).

  2. Cardiac medication use

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

    The type and dose of all cardiac medications will be followed from baseline to end of study.

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Registry information

Important dates

Study start
2014
Primary completion
2016
Study completion
2019
First posted
Mar 6, 2014
Registry last updated
Mar 1, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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