Breast Cancer Clinical Trial
— PACE in BCOfficial title:
Predicting Adverse Cardiac Events in Breast Cancer Therapy (PACE in Breast Cancer)
Verified date | February 2018 |
Source | Vanderbilt University Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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 identify biomarkers for increased risk of cardiac effects.
PURPOSE: This clinical trial is studying side effects involving the heart in women with
breast cancer receiving doxorubicin and trastuzumab.
Status | Completed |
Enrollment | 133 |
Est. completion date | March 2015 |
Est. primary completion date | March 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 85 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Louisville James Graham Brown Cancer Center | Louisville | Kentucky |
United States | MBCCOP - Meharry Medical College - Nashville | Nashville | Tennessee |
United States | Vanderbilt Heart One Hundred Oaks | Nashville | Tennessee |
United States | Vanderbilt-Ingram Cancer Center | Nashville | Tennessee |
Lead Sponsor | Collaborator |
---|---|
Vanderbilt University | National Cancer Institute (NCI) |
United States,
Geisberg CA, Abdallah WM, da Silva M, Silverstein C, Smith HM, Abramson V, Mayer I, Means-Powell J, Freehardt D, White B, Lenihan D, Sawyer DB. Circulating neuregulin during the transition from stage A to stage B/C heart failure in a breast cancer cohort. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in cardiac function by echocardiogram | change in cardiac function as measured by serial echocardiograms | 5 years | |
Secondary | Overall feasibility | 3 years |
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