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Strain Imaging in Breast Cancer Patients Receiving Trastuzumab

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 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: September 24, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention
Her 2 Positive Breast Cancer
Procedure: Transthoracic echocardiogram (ultrasound)

Study Type: Observational
Study Design: Observational Model: Cohort
Official Title: Strain Imaging in Breast Cancer Patients Receiving Trastuzumab

Resource links provided by NLM:


Further study details as provided by University of Florida:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 100
Study Start Date: September 2014
Estimated Study Completion Date: June 2019
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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 Name: Transthoracic echocardiogram

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02080390

Contacts
Contact: Dana D Leach, DNP-ARNP-BC (352)273-8933

Locations
United States, Florida
Univerisity of Florida Recruiting
Gainesville, Florida, United States, 32610
Contact: Dana D Leach, DNP-ARNP    352-273-8933    leach@medicine.ufl.edu   
Principal Investigator: Anita D Szady, MD         
Sub-Investigator: Karen Daily, DO         
Sub-Investigator: John Petersen, MD         
Sponsors and Collaborators
University of Florida
Investigators
Principal Investigator: Anita D Szady, MD University of Florida
  More Information

No publications provided

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT02080390     History of Changes
Other Study ID Numbers: IRB201300763
Study First Received: February 27, 2014
Last Updated: September 24, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Florida:
Her 2 Positive Breast Cancer
Trastuzumab
Herceptin
Heart Failure
Echocardiography

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases
Trastuzumab
Antineoplastic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014