Vanderbilt-Ingram Cancer Center

Clinical Trial VICCBRE0767

Title

Predicting Cardiac Effects of Breast Cancer Therapy

Principal Investigator(s)

Daniel Lenihan

Details

• Protocol No. VICCBRE0767
• Open Date: 06/11/2008
• Staging: Phase IV
• Age Group: Adults
• Scope: Local
• Objective: Genetic Aim: To assess whether certain polymorphisms in genes including, but not necessarily limited to, CYBA, RAC2, NCF4, MRP1, MRP2, GTSP and CBR3, increase the relative risk of developing NCI Grade 1 or greater anthracycline cardiotoxicity. Biologic Aim: To assess whether pre-treatment levels of certain biomarkers, including neuregulin, IGF-1, cardiotrophin-1, IL-6, VEGF, hepatocyte growth factor and heparin binding EGF, correlate with relative risk of developing NCI Grade 1 or greater anthracycline cardiotoxicity.
• Disease Sites: Breast
• Therapies: Correlative
• Drugs: None Specified
• Participating Institutions: Vanderbilt University; Meharry Medical College
• National Clinical Trial ID: NCT00875238
• Secondary Protocol No: Not Specified

Description

Eligibility

Criteria
 DISEASE CHARACTERISTICS:

 • Diagnosed with breast cancer

 • Receiving treatment at Vanderbilt Ingram Cancer Center and other participating oncology practices in middle Tennessee and southern Kentucky

 • Starting a standard doxorubicin hydrochloride regimen for 4 courses

 • Also scheduled to receive trastuzumab (for patients enrolled in sub-study B only)

 • No presence of metastatic disease

 • Hormone receptor status not specified

 PATIENT CHARACTERISTICS:

 • Menopausal status not specified

 • Karnofsky performance status 60-100%

 • Not pregnant

 • Negative pregnancy test

 • Additional criteria for sub-study A (MRI):

 • Glomerular filtration rate ≥ 60 mL/min

 • No implanted electronic devices, cochlear implants, metallic implants, shrapnel or neurosurgical clips

 • No prior adverse reaction to gadolinium-based contrast agents

 • Must not exceed the weight limit or be too large to fit in the MRI scanner

 PRIOR CONCURRENT THERAPY:

 • See Disease Characteristics

 • No prior anthracycline chemotherapy 

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