DWI in Assessing Treatment Response in Patients With Breast Cancer Receiving Neoadjuvant Chemotherapy

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Diffusion Weighted MR Imaging Biomarkers for Assessment of Breast Cancer Response to Neoadjuvant Treatment: A Sub-study of the I-SPY 2 TRIAL (Investigation of Serial Studies to Predict Your Therapeutic Response With Imaging And MoLecular Analysis)

Conditions
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Breast Cancer

Intervention / Treatment
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* Procedure: diffusion-weighted magnetic resonance imaging


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diffusion Weighted-MRI<br>Participants on all arms of the I-SPY II trial will undergo diffusion-weighted magnetic resonance imaging as described in the ACRIN 6698 protocol. The experimental component/intervention is whether DW-MRI can predict therapeutic response in neoadjuvant treatment for breast cancer. | Procedure: diffusion-weighted magnetic resonance imaging<br>* diffusion-weighted magnetic resonance imaging examination and subsequent radiologist interpretation<br>* Other names: DW-MRI;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pathologic Complete Response (pCR) | Pathologic complete response (pCR) is defined as the lack of all signs of cancer in tissue samples removed during surgery after Neoadjuvant treatment for Breast cancer. ie., no residual invasive disease in either breast or axillary lymph nodes after neoadjuvant therapy (ypT0/is, ypN0) Histopathologic analysis was performed using the Residual Cancer Burden system | Surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional Tumor Volume (FTV) as a Predictor of Pathologic Complete Response (pCR) | Pathologic complete response (pCR) is defined as the lack of all signs of cancer in tissue samples removed during surgery after Neoadjuvant treatment for Breast cancer. ie., no residual invasive disease in either breast or axillary lymph nodes after neoadjuvant therapy (ypT0/is, ypN0) Histopathologic analysis was performed using the Residual Cancer Burden system Functional tumor volume (FTV) (units cm3) was computed by summing all tumor voxels meeting specific enhancement criteria, with customized thresholds for each site to account for variability in MR imaging systems | Surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer, stage IV breast cancer, HER2-negative breast cancer, HER2-positive breast cancer