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


N/A
18 Years
N/A
Not Enrolling
Both
Breast Cancer

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Trial Information

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


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.


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

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

Predictors of cardio-toxicity in female patients with breast cancer exposed to trastuzumab +/- previous anthracycline agents

Outcome Description:

Identification of heart-related side effects of chemotherapy and trastuzumab using echocardiogram pictures plus blood tests.

Outcome Time Frame:

Baseline to 12 months

Safety Issue:

No

Principal Investigator

Jose Banchs, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

2007-0339

NCT ID:

NCT00806507

Start Date:

November 2008

Completion Date:

August 2011

Related Keywords:

  • Breast Cancer
  • Tissue Doppler Imaging
  • B-type natriuretic peptide
  • Advia Centaur immunoassay system
  • GE Vivid ultrasound machine
  • Roche 2010 system
  • Echocardiography
  • Herceptin
  • Breast Neoplasms

Name

Location

UT MD Anderson Cancer CenterHouston, Texas  77030
Partners Healthcare SystemsBoston, Massachusetts  02199