Clinical trial NCT02080390: Strain Imaging in Breast Cancer Patients Receiving Trastuzumab
Official title: Strain Imaging in Breast Cancer Patients Receiving Trastuzumab
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Her 2 Positive Breast Cancer
Keywords: Her 2 Positive Breast Cancer
Trastuzumab
Herceptin
Heart Failure
Echocardiography
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2014-03-06
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Women or men recieveing Trastuzumab (Herceptin) for HER2 positive breast cancer.

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Longitudinal Strain
timeFrame: Change in baseline longitudinal strain from beginning of study to end of study. Patients will be followed for a minimum of 1 year.
measure: Left Ventricular Ejection Fraction
timeFrame: Change in ejection fraction from baseline to end of study. Patients will be followed for a minimum of 1 year.
Secondary outcomes:
measure: Clinically evident congestive heart failure
timeFrame: From baseline to end of study. Patients will be followed for a minimum of 1 year.
measure: Cardiac medication use
timeFrame: Baseline to end of study. Patients will be follwed for a minimum of 1 year.
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: Univerisity of Florida
state: Florida
Study officials:
affiliation: University of Florida
name: Robert Hamburger, DO, MPH
role: PRINCIPAL_INVESTIGATOR
References: