{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,20]],"date-time":"2026-10-20T14:23:41Z","timestamp":1792506221125,"version":"4.5.0"},"reference-count":21,"publisher":"American Medical Association (AMA)","issue":"7","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JAMA Surg"],"published-print":{"date-parts":[[2025,7,1]]},"abstract":"\n Importance<\/jats:title>\n Use of modern neoadjuvant chemotherapy (NAC) regimens has markedly increased rates of pathologic complete response (pCR) in breast cancer, raising the question of whether surgical removal of the primary tumor is required for patients with pCR. For surgery to be omitted, one must be able to accurately predict pCR before surgery.<\/jats:p>\n <\/jats:sec>\n \n Objective<\/jats:title>\n To investigate if adding post-NAC core needle biopsy of the tumor bed to trimodality imaging in patients who have clinical complete response (cCR) will predict pCR (resolution of both invasive disease and ductal carcinoma in situ) in 90% or more cases.<\/jats:p>\n <\/jats:sec>\n \n Design, Setting, and Participants<\/jats:title>\n This was a phase 2, prospective, nonrandomized clinical trial. Patients were enrolled from August 2017 to June 2019. This is the final analysis, which was completed in December 2023. The setting included academic and community hospital center members of NRG (ie, the National Surgical Adjuvant Breast and Bowel Project, the Radiation Therapy Oncology Group, and the Gynecologic Oncology Group) in the US and Canada. Patients with operable (T1-T3, stage I-III) invasive ductal carcinoma who completed NAC and achieved cCR and radiological complete response (rCR) or near rCR by mammography (mass \u22641 cm and no malignant microcalcifications), ultrasound (mass \u22642 cm), and magnetic resonance imaging (no mass with rapid rise or washout kinetics).<\/jats:p>\n <\/jats:sec>\n \n Interventions<\/jats:title>\n Patients underwent marker-directed stereotactic multiple-core needle biopsy of the tumor bed with marker placement before breast-conservation surgery.<\/jats:p>\n <\/jats:sec>\n \n Main Outcomes and Measures<\/jats:title>\n End points were negative predictive value (NPV) and sensitivity of the biopsy.<\/jats:p>\n <\/jats:sec>\n \n Results<\/jats:title>\n \n A total of 105 patients were enrolled with 101 evaluable (mean [SD] age, 52.8 [10.5] years); 77 patients (76.2%) were younger than 60 years, and all breast cancer subtypes were represented with 32 (31.7%) triple-negative breast cancer, 21 (20.8%) hormone receptor\u2013positive\/epidermal growth factor receptor 2 (\n ERBB2<\/jats:italic>\n ; formerly\n HER2<\/jats:italic>\n )\u2013negative (\n ERBB2<\/jats:italic>\n \u2212) breast cancer, and 46 (45.5%)\n ERBB2<\/jats:italic>\n -positive (\n ERBB2<\/jats:italic>\n +) breast cancer. In 101 evaluable patients, 36 had residual disease at surgery (pCR\u2009=\u200964%). With imaging criteria, NPV of the biopsy was 78.3% (95% CI, 67.9%-86.6%), and the sensitivity of the biopsy was 50% (95% CI, 32.9%-67.1%). In an exploratory subset analysis, the NPV in patients with\n ERBB2<\/jats:italic>\n + breast cancer was 90% (95% CI, 76.3%-97.2%). On retrospective central review, 62 of 101 enrolled patients met imaging eligibility criteria. In this exploratory post hoc analysis, NPV in these patients was 86.8% (95% CI, 74.7%-94.5%).\n <\/jats:p>\n <\/jats:sec>\n \n Conclusions and Relevance<\/jats:title>\n These findings do not support breast conservation treatment without surgery based on the study criteria for cCR and rCR\/near rCR by trimodality imaging and negative tumor-bed biopsy. Strict adherence to imaging criteria may be required to achieve acceptable predictive values.<\/jats:p>\n <\/jats:sec>\n \n TRIAL Registration<\/jats:title>\n \n ClinicalTrials.gov Identifier:\n NCT03188393<\/jats:ext-link>\n <\/jats:p>\n <\/jats:sec>","DOI":"10.1001\/jamasurg.2025.1072","type":"journal-article","created":{"date-parts":[[2025,5,7]],"date-time":"2025-05-07T11:52:57Z","timestamp":1746618777000},"page":"723","source":"Crossref","is-referenced-by-count":22,"title":["Breast Tumor-Bed Biopsy for Pathological Complete Response Prediction"],"prefix":"10.1001","volume":"160","author":[{"given":"Mark","family":"Basik","sequence":"first","affiliation":[{"name":"Jewish General Hospital, Montr\u00e9al, Qu\u00e9bec, Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Reena S.","family":"Cecchini","sequence":"additional","affiliation":[{"name":"NRG Oncology Statistics and Data Management Center, and University of Pittsburgh School of Public Health, Department of Biostatistics and Health Data Science, Pittsburgh, Pennsylvania"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jennifer F.","family":"De Los Santos","sequence":"additional","affiliation":[{"name":"Washington University School of Medicine, Saint Louis, Missouri"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Heidi R.","family":"Umphrey","sequence":"additional","affiliation":[{"name":"NEA Baptist Memorial Hospital, Jonesboro, Arkansas"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Thomas B.","family":"Julian","sequence":"additional","affiliation":[{"name":"Allegheny Health Network Cancer Institute, Pittsburgh, Pennsylvania"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Eleftherios P.","family":"Mamounas","sequence":"additional","affiliation":[{"name":"Orlando Health UF Cancer Center, Orlando, Florida"},{"name":"Now with AdventHealth Cancer Institute, Orlando, Florida"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Julia R.","family":"White","sequence":"additional","affiliation":[{"name":"Ohio State University Comprehensive Cancer Center, Columbus"},{"name":"Now with University of Kansas Medical Center Comprehensive Cancer Center, Kansas City"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Peter C.","family":"Lucas","sequence":"additional","affiliation":[{"name":"University of Pittsburgh School of Medicine, and UPMC Hillman Cancer Center, Pittsburgh, Pennsylvania"},{"name":"Now with Mayo Clinic, Rochester, Minnesota"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christa R.","family":"Balanoff","sequence":"additional","affiliation":[{"name":"University of Kansas Medical Center and Cancer Center, Kansas City, Kansas"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Antoinette R.","family":"Tan","sequence":"additional","affiliation":[{"name":"Atrium Health Levine Cancer Institute, Wake Forest University School of Medicine, Charlotte, North Carolina"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Joseph J.","family":"Weber","sequence":"additional","affiliation":[{"name":"Advocate Aurora Health, Milwaukee, Wisconsin"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David A.","family":"Edmonson","sequence":"additional","affiliation":[{"name":"Brown University\/Women & Infants Hospital, Providence, Rhode Island"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ursa A.","family":"Brown-Glaberman","sequence":"additional","affiliation":[{"name":"University of New Mexico Comprehensive Cancer Center, Albuquerque"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Emilia J.","family":"Diego","sequence":"additional","affiliation":[{"name":"University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mediget","family":"Teshome","sequence":"additional","affiliation":[{"name":"University of Texas MD Anderson Cancer Center LAPS, Houston"},{"name":"Now with UCLA Health, Jonsson Comprehensive Cancer Center, UCLA David Geffen School of Medicine, Los Angeles, California"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Cindy B.","family":"Matsen","sequence":"additional","affiliation":[{"name":"University of Utah - Huntsman Cancer Institute LAPS, Salt Lake City"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Samantha A.","family":"Seaward","sequence":"additional","affiliation":[{"name":"Kaiser Permanente Oncology Clinical Trials, Vallejo, California"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Irene L.","family":"Wapnir","sequence":"additional","affiliation":[{"name":"Stanford Cancer Institute Palo Alto, Stanford, California"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jamie L.","family":"Wagner","sequence":"additional","affiliation":[{"name":"University of Kansas Medical Center and Cancer Center, Kansas City, Kansas"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Judy A.","family":"Tjoe","sequence":"additional","affiliation":[{"name":"Advocate Aurora Health, Aurora Research Institute, Milwaukee, Wisconsin"},{"name":"Now with Green Bay Oncology, Appleton, Wisconsin"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alastair M.","family":"Thompson","sequence":"additional","affiliation":[{"name":"Baylor College of Medicine, Houston, Texas"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Norman","family":"Wolmark","sequence":"additional","affiliation":[{"name":"NSABP Foundation Inc, University of Pittsburgh School of Medicine, and UPMC Hillman Cancer Center, Pittsburgh, Pennsylvania"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"10","reference":[{"issue":"1","key":"soi250018r1","doi-asserted-by":"publisher","first-page":"115","DOI":"10.1016\/S1470-2045(17)30716-7","article-title":"Neoadjuvant trastuzumab, pertuzumab, and chemotherapy vs trastuzumab emtansine plus pertuzumab in patients with HER2-positive breast cancer (KRISTINE): a randomized, open-label, multicenter, phase 3 trial.","volume":"19","author":"Hurvitz","year":"2018","journal-title":"Lancet Oncol"},{"issue":"9","key":"soi250018r2","doi-asserted-by":"publisher","first-page":"810","DOI":"10.1056\/NEJMoa1910549","article-title":"Pembrolizumab for early triple-negative breast cancer.","volume":"382","author":"Schmid","year":"2020","journal-title":"N Engl J Med"},{"issue":"1","key":"soi250018r3","doi-asserted-by":"publisher","first-page":"28","DOI":"10.1186\/s13058-016-0684-6","article-title":"Selective elimination of breast cancer surgery in exceptional responders: historical perspective and current trials.","volume":"18","author":"van la Parra","year":"2016","journal-title":"Breast Cancer Res"},{"issue":"24","key":"soi250018r4","doi-asserted-by":"publisher","first-page":"4540","DOI":"10.1200\/JCO.2003.05.208","article-title":"Is surgery necessary after complete clinical remission following neoadjuvant chemotherapy for early breast cancer?","volume":"21","author":"Ring","year":"2003","journal-title":"J Clin Oncol"},{"issue":"10","key":"soi250018r5","doi-asserted-by":"publisher","first-page":"1776","DOI":"10.1002\/cncr.27995","article-title":"Magnetic resonance imaging as a predictor of pathologic response in patients treated with neoadjuvant systemic treatment for operable breast cancer: Translational Breast Cancer Research Consortium trial 017.","volume":"119","author":"De Los Santos","year":"2013","journal-title":"Cancer"},{"issue":"4","key":"soi250018r6","doi-asserted-by":"publisher","first-page":"477","DOI":"10.1016\/j.amjsurg.2009.03.012","article-title":"Accuracy of ultrasonography and mammography in predicting pathologic response after neoadjuvant chemotherapy for breast cancer.","volume":"199","author":"Keune","year":"2010","journal-title":"Am J Surg"},{"issue":"11","key":"soi250018r7","doi-asserted-by":"publisher","first-page":"1443","DOI":"10.1245\/s10434-006-9086-9","article-title":"Accuracy of the combination of mammography and sonography in predicting tumor response in breast cancer patients after neoadjuvant chemotherapy.","volume":"13","author":"Peintinger","year":"2006","journal-title":"Ann Surg Oncol"},{"issue":"3","key":"soi250018r8","doi-asserted-by":"publisher","first-page":"789","DOI":"10.1245\/s10434-015-4918-0","article-title":"Can routine imaging after neoadjuvant chemotherapy in breast cancer predict pathologic complete response?","volume":"23","author":"Schaefgen","year":"2016","journal-title":"Ann Surg Oncol"},{"issue":"1","key":"soi250018r9","doi-asserted-by":"publisher","first-page":"1","DOI":"10.1016\/0197-2456(89)90015-9","article-title":"Optimal 2-stage designs for phase 2 clinical trials.","volume":"10","author":"Simon","year":"1989","journal-title":"Control Clin Trials"},{"issue":"15","key":"soi250018r10","doi-asserted-by":"publisher","first-page":"1796","DOI":"10.1200\/JCO.2011.38.8595","article-title":"Definition and impact of pathologic complete response on prognosis after neoadjuvant chemotherapy in various intrinsic breast cancer subtypes.","volume":"30","author":"von Minckwitz","year":"2012","journal-title":"J Clin Oncol"},{"issue":"28","key":"soi250018r11","doi-asserted-by":"publisher","first-page":"4414","DOI":"10.1200\/JCO.2007.10.6823","article-title":"Measurement of residual breast cancer burden to predict survival after neoadjuvant chemotherapy.","volume":"25","author":"Symmans","year":"2007","journal-title":"J Clin Oncol"},{"key":"soi250018r12","doi-asserted-by":"publisher","DOI":"10.3389\/fonc.2021.617167","article-title":"Meta-analysis of shrinkage mode after neoadjuvant chemotherapy for breast cancers: association with hormonal receptor.","volume":"11","author":"Zheng","year":"2022","journal-title":"Front Oncol"},{"issue":"3","key":"soi250018r13","doi-asserted-by":"publisher","first-page":"576","DOI":"10.1097\/SLA.0000000000004246","article-title":"Diagnosing pathologic complete response in the breast after neoadjuvant systemic treatment of breast cancer patients by minimal invasive biopsy, oral presentation, San Antonio Breast Cancer Symposium, December 13, 2019, prog number GS5-03.","volume":"275","author":"Heil","year":"2022","journal-title":"Ann Surg"},{"issue":"2","key":"soi250018r14","doi-asserted-by":"publisher","first-page":"1076","DOI":"10.1245\/s10434-021-10847-9","article-title":"Vacuum-assisted breast biopsy after neoadjuvant systemic treatment for reliable exclusion of residual cancer in breast cancer patients.","volume":"29","author":"Koelbel","year":"2022","journal-title":"Ann Surg Oncol"},{"issue":"6","key":"soi250018r15","doi-asserted-by":"publisher","first-page":"3243","DOI":"10.1245\/s10434-020-09273-0","article-title":"Minimally invasive complete response assessment of the breast after neoadjuvant systemic therapy for early breast cancer (MICRA trial): interim analysis of a multicenter observational cohort study.","volume":"28","author":"van Loevezijn","year":"2021","journal-title":"Ann Surg Oncol"},{"issue":"1","key":"soi250018r16","doi-asserted-by":"publisher","first-page":"97","DOI":"10.1007\/s10549-020-05678-3","article-title":"Prediction of pathologic complete response using image-guided biopsy after neoadjuvant chemotherapy in breast cancer patients selected based on MRI findings: a prospective feasibility trial.","volume":"182","author":"Lee","year":"2020","journal-title":"Breast Cancer Res Treat"},{"issue":"12","key":"soi250018r17","doi-asserted-by":"publisher","DOI":"10.1001\/jamasurg.2020.4103","article-title":"Accuracy of postneoadjuvant chemotherapy image-guided breast biopsy to predict residual cancer.","volume":"155","author":"Tasoulis","year":"2020","journal-title":"JAMA Surg"},{"issue":"12","key":"soi250018r18","doi-asserted-by":"publisher","first-page":"1517","DOI":"10.1016\/S1470-2045(22)00613-1","article-title":"Eliminating breast surgery for invasive breast cancer in exceptional responders to neoadjuvant systemic therapy: a multicenter, single-arm, phase 2 trial.","volume":"23","author":"Kuerer","year":"2022","journal-title":"Lancet Oncol"},{"key":"soi250018r19","doi-asserted-by":"publisher","first-page":"S278","DOI":"10.1016\/j.annonc.2023.09.441","article-title":"Omission of breast surgery after neoadjuvant systemic therapy for invasive cancer: 3-year preplanned primary-endpoint on a phase II multicentre prospective trial.","volume":"34","author":"Kuerer","year":"2023","journal-title":"Ann Oncol"},{"issue":"17","key":"soi250018r20","doi-asserted-by":"publisher","first-page":"1903","DOI":"10.1200\/JCO.21.02439","article-title":"Intelligent vacuum-assisted biopsy to identify breast cancer patients with pathologic complete response (ypT0 and ypN0) after neoadjuvant systemic treatment for omission of breast and axillary surgery.","volume":"40","author":"Pfob","year":"2022","journal-title":"J Clin Oncol"},{"issue":"1","key":"soi250018r21","doi-asserted-by":"publisher","first-page":"61","DOI":"10.4048\/jbc.2023.0265","article-title":"Omission of breast surgery in predicted pathologic complete response after neoadjuvant systemic therapy: a multicenter, single-arm, noninferiority trial.","volume":"27","author":"Jung","year":"2024","journal-title":"J Breast Cancer"}],"container-title":["JAMA Surgery"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/jamanetwork.com\/journals\/jamasurgery\/articlepdf\/2833511\/jamasurgery_basik_2025_oi_250018_1751386034.78695.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,7,9]],"date-time":"2025-07-09T15:00:59Z","timestamp":1752073259000},"score":1,"resource":{"primary":{"URL":"https:\/\/jamanetwork.com\/journals\/jamasurgery\/fullarticle\/2833511"}},"subtitle":["The NRG-BR005 Nonrandomized Clinical Trial"],"short-title":[],"issued":{"date-parts":[[2025,7,1]]},"references-count":21,"journal-issue":{"issue":"7","published-print":{"date-parts":[[2025,7,1]]}},"URL":"https:\/\/doi.org\/10.1001\/jamasurg.2025.1072","relation":{},"ISSN":["2168-6254"],"issn-type":[{"value":"2168-6254","type":"print"}],"subject":[],"published":{"date-parts":[[2025,7,1]]}}}