Biopsy Feasibility Trial for Breast Cancer Pathologic Complete Response Detection after Neoadjuvant Chemotherapy: Imaging Assessment and Correlation Endpoints

This study was designed to present the secondary imaging endpoints of the trial for evaluating mammogram (MMG), ultrasound (US) and image guided biopsy (IGBx) assessment of pathologic complete response (pCR) in breast cancer (BC) patients undergoing neoadjuvant chemotherapy (NAC). Patients with T1-3, N0-3, M0 triple-negative or HER2-positive BC who received NAC were enrolled in an Institutional Review Board-approved prospective, clinical trial. Patients underwent US and MMG at baseline and after NAC. Images were evaluated for residual abnormality and to determine modality for IGBx [US-guided (USG) or stereotactic guided (SG)]. Fine-needle aspiration and 9-G, vacuum-assisted core biopsy (VACBx) of tumor bed was performed after NAC and was compared with histopathology at surgery. Forty patients were enrolled. Median age was 50.5 (range 26-76) years; median baseline tumor size was 2.4 cm (range 0.8-6.3) and 1 cm (range 0-5.5) after NAC. Nineteen patients had pCR: 6 (32%) had residual Ca2+ presurgery, 5 (26%) residual mass, 1 (5%) mass with calcifications, and 7 (37%) no residual imaging abnormality. Sensitivity, specificity, and accuracy of US, MMG, and IGBx for pCR were 47/95/73%, 53/90/73%, and 100/95/98%, respectively. Twenty-five (63%) patients had SGBx and 15 (37%) had US-guided biopsy (USGBx). Median number of cores was higher with SGBx (12, range 6-14) than with USGBx (8, range 4-12), p < 0.002. Positive predictive value for pCR was significantly higher for SG VACBx than for USG VACBx (100 vs. 60%, p < 0.05). SG VACBx is the preferred IGBx modality for identifying patients with pCR for trials testing the safety of eliminating surgery.