Breast Cancer Clinical Trial
DWI in Assessing Treatment Response in Patients With Breast Cancer Receiving Neoadjuvant Chemotherapy
Summary
RATIONALE: Imaging procedures, such as diffusion-weighted magnetic resonance imaging (DWI) and dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI), may help in evaluating how well patients with breast cancer respond to treatment.
PURPOSE: This research trial studies DWI and DCE-MRI in assessing treatment response in patients with breast cancer undergoing neoadjuvant chemotherapy.
Full Description
OBJECTIVES:
Primary
To determine if the change in tumor apparent diffusion coefficient (ADC) value measured from each treatment timepoint to baseline is predictive of pathologic complete response (pCR).
Secondary
To determine if the combined measurement of change in tumor ADC value, change in tumor volume, and change in peak signal-enhancement ratio (SER) is predictive of pCR.
To investigate the relative effectiveness of the individual measurements, change in tumor ADC value, change in tumor volume, and change in peak SER for predicting pCR in experimental treatment arms.
To assess the test-retest reproducibility of ADC metrics applied to breast tumors.
OUTLINE: This is a multicenter study.
Patients undergo diffusion-weighted magnetic resonance imaging (DWI) at baseline, after week 3 of neoadjuvant paclitaxel regimen, and prior to and after completion of 4 courses of neoadjuvant chemotherapy. Patients then undergo surgery. Patients undergo DWI prior to contrast administration for dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI).
After completion of treatment procedure, patients are followed up for 5 years on the I-SPY 2 TRIAL.
Eligibility Criteria
DISEASE CHARACTERISTICS:
Meets I-SPY 2 TRIAL inclusion criteria
High-risk for recurrent disease
PATIENT CHARACTERISTICS:
Able to tolerate imaging required by protocol
PRIOR CONCURRENT THERAPY:
Not specified
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There are 7 Locations for this study
Birmingham Alabama, 35294, United States
San Francisco California, 94143, United States
Minneapolis Minnesota, 55455, United States
Portland Oregon, 97239, United States
Philadelphia Pennsylvania, 19104, United States
Houston Texas, 77030, United States
Seattle Washington, 98195, United States
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