A Multi-Center Study in Patients Undergoing Anthracycline-Based Chemotherapy to Assess the Effectiveness of Using Biomarkers to Detect and Identify Cardiotoxicity and Describe Treatment
- To assess the sensitivity and specificity of cardiac biomarkers, specifically B-type
natriuretic peptide (BNP) and troponin I, in detecting cardiotoxicity in patients
undergoing anthracycline-based chemotherapy.
- To define the sensitivity and specificity of serial LVEF measurements in detecting
- To describe the clinical management and outcomes of patients identified with abnormal
cardiac biomarkers or clinically defined cardiotoxicity during chemotherapy.
- To confirm the supportive utility of patient-reported symptoms for the development of
OUTLINE: This is a multicenter study.
Patients receive anthracycline-based chemotherapy for approximately 8 courses.
Patients undergo physical exam, ECHO, EKG, and laboratory assessments, including measurement
of B-type natriuretic peptide (BNP) and troponin I biomarkers, at baseline and periodically
for up to 12 months. Patients also complete the M.D. Anderson Symptom Index-Heart Failure
questionnaire at baseline and periodically for up to 12 months. Patients with an identified
cardiac event, suspected cardiotoxicity, or abnormal biomarkers are referred to a
cardiologist for treatment.
After completion of chemotherapy, patients are followed up at 6 and 12 months.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Sensitivity and specificity of cardiac biomarkers in detecting cardiotoxicity within 12 months of initiation of anthracycline-based chemotherapy
Michael J. Fisch, MD, MPH, FACP
M.D. Anderson Cancer Center
United States: Institutional Review Board
|M. D. Anderson Cancer Center at University of Texas||Houston, Texas 77030-4009|