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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 UniversityMeharry Medical College
  • National Clinical Trial ID: NCT00875238
  • Secondary Protocol No: Not Specified

Description

None Provided.

Eligibility

Ages Eligible for Study:18 Years to 85 Years
Genders Eligible for Study:Both
Accepts Healthy Volunteers:No

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