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A Phase II Trial Assessing the Accuracy of Tumor Bed Biopsies in Predicting Pathologic Response in Patients With Clinical/Radiologic Complete Response After Neoadjuvant Chemotherapy in Order to Explore the Feasibility of Breast Conserving Treatment Without Surgery

Primary Objective To assess the accuracy of post-neoadjuvant systemic therapy (NST) image-directed tumor bed biopsy for pathologic complete response (pCR), defined as resolution of both invasive disease and DCIS (von Minckwitz 2012), in cases of clinical and radiologic complete response with trimodality imaging. This will determine whether post-NST tumor bed needle core biopsies in addition to clinical examination and trimodality imaging can identify appropriate patients after NST, who are optimal candidates to proceed with radiotherapy treatment without formal breast conserving surgery (lumpectomy). Secondary Objectives To collect axillary pathology results, surgical staging methods (sentinel lymph node biopsy and/or axillary lymph node dissection), and management (surgery and/or radiation) in order to determine axillary nodal response to neoadjuvant chemotherapy and its relationship to breast pCR. In addition, to correlate imaging results with pathologic nodal status following neoadjuvant chemotherapy for future planning of axillary management in the next study. To retrospectively assess the negative predictive value (NPV) of a trimodality imaging algorithm in combination with the tumor bed biopsy for predicting pCR, and to collect all trimodality imaging data to determine which combination of the trimodality imaging best identifies the group achieving pCR. To correlate the number of needle cores and tumor bed clip retrieval with the NPV of the tumor site biopsy. To determine the clinical, imaging, pathologic, and molecular tumor factors associated with the highest NPVs of post-NST tumor bed biopsies. To improve identification and selection of patients with breast and possible axillary pCR for future trial planning, routine biomarkers (ER, PR, HER2 neu, and Ki67) will be collected to allow comparison to image/clinical CR, and tumor bed biopsies.

Primary Objective To assess the accuracy of post-neoadjuvant systemic therapy (NST) image-directed tumor bed biopsy for pathologic complete response (pCR), defined as resolution of both invasive disease and DCIS (von Minckwitz 2012), in cases of clinical and radiologic complete response with trimodality imaging. This will determine whether post-NST tumor bed needle core biopsies in addition to clinical examination and trimodality imaging can identify appropriate patients after NST, who are optimal candidates to proceed with radiotherapy treatment without formal breast conserving surgery (lumpectomy). Secondary Objectives To collect axillary pathology results, surgical staging methods (sentinel lymph node biopsy and/or axillary lymph node dissection), and management (surgery and/or radiation) in order to determine axillary nodal response to neoadjuvant chemotherapy and its relationship to breast pCR. In addition, to correlate imaging results with pathologic nodal status following neoadjuvant chemotherapy for future planning of axillary management in the next study. To retrospectively assess the negative predictive value (NPV) of a trimodality imaging algorithm in combination with the tumor bed biopsy for predicting pCR, and to collect all trimodality imaging data to determine which combination of the trimodality imaging best identifies the group achieving pCR. To correlate the number of needle cores and tumor bed clip retrieval with the NPV of the tumor site biopsy. To determine the clinical, imaging, pathologic, and molecular tumor factors associated with the highest NPVs of post-NST tumor bed biopsies. To improve identification and selection of patients with breast and possible axillary pCR for future trial planning, routine biomarkers (ER, PR, HER2 neu, and Ki67) will be collected to allow comparison to image/clinical CR, and tumor bed biopsies.