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

NCT00806507 | Completed

• 1 other identifier: 2007-0339
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Breast Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

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

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

  Baseline to 12 months

Study Arms (1)

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; Procedure: Blood Test

Interventions

Echocardiograms PROCEDURE

Additional views performed in 5-10 minutes of regularly scheduled echocardiograms.

Echocardiogram + Blood Test

Blood Test PROCEDURE

Measuring of hormones and metabolic proteins (such as sugars and acids).

Echocardiogram + Blood Test

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Breast cancer patients treated with chemotherapy and Herceptin (trastuzumab)

You may qualify if:

• Age 18 years or older
• HER-2 positive breast cancer
• 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
• Normal baseline left ventricular ejection fraction.

You may not qualify if:

• Pre-existing cardiomyopathy (Left Ventricular Ejection Fraction (LVEF) \< 50%)
• Other contraindication to Herceptin therapy

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Massachusetts General Hospital: collaborator

Study Sites (2)

Partners Healthcare Systems

Boston, Massachusetts, 02199, United States

Location

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• The University of Texas M.D.Anderson Cancer Center

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Hematologic Tests

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Jose Banchs, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2008
• First Posted: December 10, 2008
• Study Start: November 1, 2008
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2011
• Last Updated: July 23, 2012

Record last verified: 2012-07

Locations

US (2)