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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00806507
First Posted: December 10, 2008
Last Update Posted: July 23, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Massachusetts General Hospital
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
  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 ]
    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).

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00806507     History of Changes
Other Study ID Numbers: 2007-0339
First Submitted: November 20, 2008
First Posted: December 10, 2008
Last Update Posted: July 23, 2012
Last Verified: July 2012

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
Cardiotoxicity
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Pathologic Processes
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders
Radiation Injuries
Wounds and Injuries