a study on Breast Cancer
RATIONALE: Comparing results of diagnostic procedures performed before, during, and after chemotherapy may help doctors predict a patient's response to treatment and help plan the most effective treatment.
PURPOSE: Diagnostic trial to study magnetic resonance imaging (MRI) and biomarkers in women who are receiving chemotherapy before surgery for locally advanced breast cancer.
Contrast-Enhanced Breast MRI, MRS, And Correlative Science Studies To Characterize Tumor Response In Patients Undergoing Neoadjuvant Treatment For Locally Advanced Breast Cancer
OUTLINE: This is a diagnostic, multicenter study conducted concurrently with CALGB-150012/ACRIN-6657 imaging protocol and concurrently with neoadjuvant anthracycline-based chemotherapy.
Patients receive an injection of gadopentetate dimeglumine and undergo magnetic resonance imaging (MRI) of the breast before initiation, 1-3 days after initiation, and then after completion of neoadjuvant anthracycline-based chemotherapy and prior to surgery. Patients who previously received a taxane also undergo an additional contrast-enhanced MRI scan.
Patients undergo biopsies before initiation and at the time of surgery. Patients also undergo blood draws at the time of the first biopsy and prior to surgery. Serum and tissue samples are used to assess biomarkers of genetic instability, cell cycle progression and cellular proliferation as predictors for anthracycline responsiveness, markers of apoptotic potential as predictors for taxane responsiveness in vivo, angiogenesis, hormone receptors, and molecular profiles using immunohistochemical methods.
Mammograms and possibly ultrasounds are performed prior to and after chemotherapy (before surgery).
Patients are followed every 6 months for 5 years and then annually for up to 10 years.
PROJECTED ACCRUAL: A total of 384 patients will be accrued for this study within 3 years.
Breast Cancer stage II breast cancer stage IV breast cancer stage IIIA breast cancer stage IIIB breast cancer stage IIIC breast cancer inflammatory breast cancer
For females ages 18 years and up
18 and over
No uncontrolled or severe cardiovascular disease
PRIOR CONCURRENT THERAPY:
No prior chemotherapy to the ipsilateral breast for this malignancy
At least 4 weeks since prior tamoxifen or raloxifene
No prior radiotherapy to the ipsilateral breast for this malignancy
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