Strain Imaging in Breast Cancer Patients Receiving Trastuzumab

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified March 2014 by University of Florida
Sponsor:
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT02080390
First received: February 27, 2014
Last updated: March 4, 2014
Last verified: March 2014

February 27, 2014
March 4, 2014
June 2014
June 2017   (final data collection date for primary outcome measure)
  • 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. ] [ Designated as safety issue: No ]
    Each transthoracic echocardiogram obtained during the patient's treatment will be assessed for longitudinal strain.
  • 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. ] [ Designated as safety issue: No ]
    Left ventricular ejection fraction from all clinically indicated transthoracic echocardiograms will be compared from baseline through the end of the study.
Same as current
Complete list of historical versions of study NCT02080390 on ClinicalTrials.gov Archive Site
  • Clinically evident congestive heart failure [ Time Frame: From baseline to end of study. Patients will be followed for a minimum of 1 year. ] [ Designated as safety issue: No ]
    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).
  • Cardiac medication use [ Time Frame: Baseline to end of study. Patients will be follwed for a minimum of 1 year. ] [ Designated as safety issue: No ]
    The type and dose of all cardiac medications will be followed from baseline to end of study.
Same as current
Not Provided
Not Provided
 
Strain Imaging in Breast Cancer Patients Receiving Trastuzumab
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.

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.

Observational
Observational Model: Cohort
Not Provided
Not Provided
Probability Sample

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

Her 2 Positive Breast Cancer
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 Name: Transthoracic echocardiogram
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.
Intervention: Procedure: Transthoracic echocardiogram (ultrasound)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
100
June 2019
June 2017   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact: Dana D Leach, DNP-ARNP-BC (352)273-8933
United States
 
NCT02080390
szady2014
No
University of Florida
University of Florida
Not Provided
Principal Investigator: Anita D Szady, MD University of Florida
University of Florida
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP