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

This study has been completed.
Sponsor:
Collaborator:
Massachusetts General Hospital
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00806507
First received: November 20, 2008
Last updated: July 19, 2012
Last verified: July 2012
  Purpose

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.


Condition Intervention
Breast Cancer
Procedure: Echocardiograms
Procedure: Blood Test

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Early Detection and Prediction of Chemotherapy Induced Cardiac Toxicity in Breast Cancer Patients

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Predictors of cardio-toxicity in female patients with breast cancer exposed to trastuzumab +/- previous anthracycline agents [ Time Frame: Baseline to 12 months ] [ Designated as safety issue: No ]
    Identification of heart-related side effects of chemotherapy and trastuzumab using echocardiogram pictures plus blood tests.


Enrollment: 45
Study Start Date: November 2008
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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).

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.

  Eligibility

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

Breast cancer patients treated with chemotherapy and Herceptin (trastuzumab)

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00806507

Locations
United States, Massachusetts
Partners Healthcare Systems
Boston, Massachusetts, United States, 02199
United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Massachusetts General Hospital
Investigators
Principal Investigator: Jose Banchs, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00806507     History of Changes
Other Study ID Numbers: 2007-0339
Study First Received: November 20, 2008
Last Updated: July 19, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Tissue Doppler Imaging
B-type natriuretic peptide
Advia Centaur immunoassay system
GE Vivid ultrasound machine
Roche 2010 system
Echocardiography
Herceptin

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Natriuretic Peptide, Brain
Natriuretic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 16, 2014