Early Detection and Prediction of Chemotherapy Induced Cardiac Toxicity in Breast Cancer Patients

July 19, 2012 updated by: M.D. Anderson Cancer Center
The goal of this clinical research study is to learn whether different ways of viewing echocardiogram pictures along with blood tests can help to see heart-related side effects of chemotherapy and trastuzumab earlier than the usual tests.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Echocardiogram:

Because of the heart-related side effects of chemotherapy and trastuzumab, your regular doctor will monitor your heart's function as part of your routine care. You will have echocardiograms performed before you begin treatment, and then every 3 months. An echocardiogram uses sound waves to check your heart's health.

If you decide to take part in this study, researchers will take several additional pictures of your heart during each of your regularly scheduled echocardiograms. The additional pictures will make the procedure take about 5-10 minutes longer than the regular echocardiogram. These pictures will be viewed in a different way than the standard echocardiogram pictures. Researchers hope viewing the pictures this way can help researchers to find heart problems earlier than the usual tests.

Blood Tests:

Blood (about 4 teaspoon each time) will be drawn during the routine blood draw that occurs closest to the regularly scheduled echocardiograms.

The heart produces hormones called BNP and NT-proBNP. These hormones can be measured in the blood. BNP and NT-proBNP levels can be higher when the heart is not working as well. Researchers will measure these hormones at the time of each echocardiogram. Researchers hope to learn whether measuring these hormones can help identify the heart-related side effects of chemotherapy and trastuzumab earlier than the usual tests.

Researchers will also measure metabolic proteins (such as sugars and acids) in the blood. Researchers hope to learn whether measuring these metabolic proteins can help identify the heart-related side effects of chemotherapy and trastuzumab earlier than the usual tests.

Because protein, sugar or acid levels may be temporarily changed after you eat, you will be asked not to eat overnight before having your blood drawn.

Study Visits:

You will have 6 study visits around the time that you have an echocardiogram. These visits will occur before you take Herceptin, when you begin Herceptin, and 3, 6, 9, and 12 months later. These study visits will be scheduled on days when you are already making a visit to your regular doctor. You will not have to make any special visits to the hospital for this research study.

During each study visit, you will be asked about any symptoms you may be experiencing, and any medications you may be taking. Your blood pressure and heart rate will be measured.

You will also take a quality of life questionnaire at each study visit. This questionnaire asks you how the cancer may have interfered with your daily life. It should take about 15 minutes to complete.

Length of Study:

You will be considered off-study once you complete the 6 study visits.

This is an investigational study. Up to 100 patients will take part in this multicenter study. Up to 20 patients will be enrolled at M. D. Anderson.

Study Type

Observational

Enrollment (Actual)

45

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02199
        • Partners Healthcare Systems
    • Texas
      • Houston, Texas, United States, 77030
        • UT MD Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Breast cancer patients treated with chemotherapy and Herceptin (trastuzumab)

Description

Inclusion Criteria:

  1. Age 18 years or older
  2. HER-2 positive breast cancer
  3. Scheduled to receive Herceptin infusion therapy after exposure to anthracycline-based chemotherapy in one of the following manners: Adjuvant or neoadjuvant treatment with anthracycline-based chemotherapy preceded or followed by Herceptin infusion therapy, Herceptin monotherapy in patients with metastatic disease previously treated with anthracycline-based chemotherapy, Herceptin in combination with non-anthracycline chemotherapy in patients with metastatic disease previously treated with anthracycline-based chemotherapy
  4. Normal baseline left ventricular ejection fraction.

Exclusion Criteria:

  1. Pre-existing cardiomyopathy (Left Ventricular Ejection Fraction (LVEF) < 50%)
  2. Other contraindication to Herceptin therapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Echocardiogram + Blood Test
Additional Echocardiogram views performed in 5-10 minutes of regularly scheduled echocardiograms plus blood tests measuring of hormones and metabolic proteins (such as sugars and acids).
Procedure: Echocardiograms
Additional views performed in 5-10 minutes of regularly scheduled echocardiograms.
Procedure: Blood Test
Measuring of hormones and metabolic proteins (such as sugars and acids).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Predictors of cardio-toxicity in female patients with breast cancer exposed to trastuzumab +/- previous anthracycline agents
Time Frame: Baseline to 12 months
Identification of heart-related side effects of chemotherapy and trastuzumab using echocardiogram pictures plus blood tests.
Baseline to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Collaborators

Massachusetts General Hospital

Investigators

  • Principal Investigator: Jose Banchs, MD, M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2008

Primary Completion (ACTUAL)

August 1, 2011

Study Completion (ACTUAL)

August 1, 2011

Study Registration Dates

First Submitted

November 20, 2008

First Submitted That Met QC Criteria

December 9, 2008

First Posted (ESTIMATE)

December 10, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

July 23, 2012

Last Update Submitted That Met QC Criteria

July 19, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2007-0339

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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