Status:
COMPLETED
Side Effects Involving the Heart in Women With Breast Cancer Receiving Doxorubicin and Trastuzumab
Lead Sponsor:
Vanderbilt University
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Breast Cancer
Cardiac Toxicity
Eligibility:
All Genders
18-85 years
Brief Summary
RATIONALE: Studying samples of blood and tissue in the laboratory from women receiving doxorubicin and trastuzumab for breast cancer may help doctors learn more about changes that occur in DNA and ide...
Detailed Description
OBJECTIVES: Primary * To determine if polymorphisms in genes (e.g., CYBA, RAC2, NCF4, MRP1, MRP2, GTSP and CBR3) in women with breast cancer treated with doxorubicin hydrochloride increase the relat...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
June 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 1 2015
Estimated Enrollment :
133 Patients enrolled
Trial Details
Trial ID
NCT00875238
Start Date
June 1 2008
End Date
March 1 2015
Last Update
February 19 2018
Active Locations (4)
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1
University of Louisville James Graham Brown Cancer Center
Louisville, Kentucky, United States, 40202
2
Vanderbilt Heart One Hundred Oaks
Nashville, Tennessee, United States, 37204
3
MBCCOP - Meharry Medical College - Nashville
Nashville, Tennessee, United States, 37208
4
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232-6838