{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,29]],"date-time":"2026-10-29T20:55:39Z","timestamp":1793307339020,"version":"4.5.0"},"reference-count":20,"publisher":"American Society of Clinical Oncology (ASCO)","issue":"14","content-domain":{"domain":["ascopubs.org"],"crossmark-restriction":true},"short-container-title":["J Clin Oncol"],"published-print":{"date-parts":[[2026,5,10]]},"abstract":"<jats:sec>\n                    <jats:title>PURPOSE<\/jats:title>\n                    <jats:p>Patients with stage II\/III human epidermal growth factor receptor 2 (HER2)\u2013positive or triple-negative breast cancer (TNBC) frequently receive neoadjuvant therapy (NAT). Although pathologic complete response (pCR) correlates with improved outcomes, many non-pCR patients have long-term survival. Circulating tumor-DNA (ctDNA) minimal residual disease (MRD) assessment may provide additional or superior risk stratification.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>METHODS<\/jats:title>\n                    <jats:p>Pathologic Response Evaluation and Detection in Circulating Tumor-DNA is a prospective, multicenter study evaluating ctDNA as a biomarker of treatment response using a tumor-informed, ultrasensitive (&lt;100 parts per million) assay. The primary objective was to determine whether the negative predictive value (NPV) of post-NAT ctDNA for pCR was \u226590%. A prespecified secondary objective for the TNBC cohort was to assess associations between ctDNA and 5-year invasive disease-free survival (IDFS). ctDNA was evaluated at baseline, after NAT before surgery, and after surgery.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>RESULTS<\/jats:title>\n                    <jats:p>\n                      Of 227 enrolled patients, 220 were evaluable for pCR (48% HER2-positive; 52% TNBC) and 91 patients (41%) had pCR. The primary objective was not met. Although all patients with pCR were ctDNA-negative after NAT, 40% of non-pCR patients were also ctDNA-negative (NPV, 60% [95% CI, 0.50 to 0.69]). However, the prespecified secondary objective was met. Detectable ctDNA after NAT was prognostic for recurrence (hazard ratio [HR], 8.9 [95% CI, 2.4 to 33];\n                      <jats:italic toggle=\"yes\">P<\/jats:italic>\n                      = .001), independent of pCR. Additionally, detectable ctDNA after surgery identified patients at extremely high recurrence risk (HR, 128 [95% CI, 15 to 1,083];\n                      <jats:italic toggle=\"yes\">P<\/jats:italic>\n                      &lt; .001), while ctDNA-negative patients after surgery had 94% 5-year IDFS.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>CONCLUSION<\/jats:title>\n                    <jats:p>In HER2-positive breast cancer and TNBC, ctDNA after NAT does not discriminate pCR from non-pCR. However, ctDNA provides markedly superior prognostic stratification, identifying patients with exceptional outcomes and those at extreme risk. These findings support ctDNA-guided therapeutic de-escalation and escalation strategies.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1200\/jco-25-02934","type":"journal-article","created":{"date-parts":[[2026,3,10]],"date-time":"2026-03-10T20:00:11Z","timestamp":1773172811000},"page":"1283-1295","update-policy":"https:\/\/doi.org\/10.1200\/crossmark","source":"Crossref","is-referenced-by-count":19,"title":["The Pathologic Response Evaluation and Detection in Circulating Tumor-DNA Study: Ultrasensitive Circulating Tumor-DNA Assessment of Breast Cancer Minimal Residual Disease"],"prefix":"10.1200","volume":"44","clinical-trial-number":[{"clinical-trial-number":"nct02743910","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-4762-2152","authenticated-orcid":false,"given":"Natasha B.","family":"Hunter","sequence":"first","affiliation":[{"name":"Fred Hutchinson Cancer Center, University of Washington, Seattle, WA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8178-6612","authenticated-orcid":false,"given":"Heather A.","family":"Parsons","sequence":"additional","affiliation":[{"name":"Fred Hutchinson Cancer Center, University of Washington, Seattle, WA"},{"name":"Dana Farber Cancer Institute, Boston, MA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Leslie","family":"Cope","sequence":"additional","affiliation":[{"name":"Johns Hopkins University, Baltimore, MD"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1084-6918","authenticated-orcid":false,"given":"Jenna V.","family":"Canzoniero","sequence":"additional","affiliation":[{"name":"Johns Hopkins University, Baltimore, MD"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5640-9070","authenticated-orcid":false,"given":"Fabio C.P.","family":"Navarro","sequence":"additional","affiliation":[{"name":"Personalis, Fremont, CA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2080-4172","authenticated-orcid":false,"given":"Sherif","family":"El-Refai","sequence":"additional","affiliation":[{"name":"Personalis, Fremont, CA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1898-180X","authenticated-orcid":false,"given":"Jesus D.","family":"Anampa","sequence":"additional","affiliation":[{"name":"Montefiore Einstein Comprehensive Cancer Center, Bronx, NY"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9031-2010","authenticated-orcid":false,"given":"Joseph A.","family":"Sparano","sequence":"additional","affiliation":[{"name":"Montefiore Einstein Comprehensive Cancer Center, Bronx, NY"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4284-5656","authenticated-orcid":false,"given":"Mothaffar","family":"Rimawi","sequence":"additional","affiliation":[{"name":"Baylor College of Medicine, Houston, TX"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8701-7889","authenticated-orcid":false,"given":"Anna Maria","family":"Storniolo","sequence":"additional","affiliation":[{"name":"Indiana University Melvin and Bren Simon Comprehensive Cancer Center, Indianapolis, IN"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4431-7101","authenticated-orcid":false,"given":"Candace","family":"Mainor","sequence":"additional","affiliation":[{"name":"Medstar Georgetown University-Hospital-Lombardi Comprehensive Cancer Center, Washington, DC"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5248-0876","authenticated-orcid":false,"given":"Rita","family":"Nanda","sequence":"additional","affiliation":[{"name":"University of Chicago, Chicago, IL"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1297-4251","authenticated-orcid":false,"given":"Angela","family":"DeMichele","sequence":"additional","affiliation":[{"name":"University of Pennsylvania, Philadelphia, PA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9177-552X","authenticated-orcid":false,"given":"Gaorav P.","family":"Gupta","sequence":"additional","affiliation":[{"name":"University of North Carolina, Chapel Hill, NC"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1862-3367","authenticated-orcid":false,"given":"Erica J.","family":"Stringer-Reasor","sequence":"additional","affiliation":[{"name":"University of Alabama at Birmingham, Birmingham, AL"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6615-7076","authenticated-orcid":false,"given":"Filipa","family":"Lynce","sequence":"additional","affiliation":[{"name":"Dana Farber Cancer Institute, Boston, MA"},{"name":"Medstar Georgetown University-Hospital-Lombardi Comprehensive Cancer Center, Washington, DC"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9602-8611","authenticated-orcid":false,"given":"Erin F.","family":"Cobain","sequence":"additional","affiliation":[{"name":"Rogel Cancer Center, University of Michigan, Ann Arbor, MI"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shannon","family":"Puhalla","sequence":"additional","affiliation":[{"name":"University of Pittsburgh, UPMC Hillman Cancer Center, Pittsburgh, PA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7691-2389","authenticated-orcid":false,"given":"Rachel","family":"Jankowitz","sequence":"additional","affiliation":[{"name":"University of Pennsylvania, Philadelphia, PA"},{"name":"University of Pittsburgh, UPMC Hillman Cancer Center, Pittsburgh, PA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Brent","family":"Rexer","sequence":"additional","affiliation":[{"name":"Vanderbilt University Medical Center, Nashville, TN"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8147-335X","authenticated-orcid":false,"given":"Ingrid","family":"Mayer","sequence":"additional","affiliation":[{"name":"Vanderbilt University Medical Center, Nashville, TN"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0204-2012","authenticated-orcid":false,"given":"E. Shelley","family":"Hwang","sequence":"additional","affiliation":[{"name":"Duke University and Duke Cancer Institute, Durham, NC"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kimberly","family":"Blackwell","sequence":"additional","affiliation":[{"name":"Duke University and Duke Cancer Institute, Durham, NC"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Walid","family":"El Ayass","sequence":"additional","affiliation":[{"name":"Tidal Health, Peninsula Regional Medical Center, Salisbury, MD"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Young","family":"Lee","sequence":"additional","affiliation":[{"name":"Anne Arundel Medical Center, Annapolis, MD"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5370-3610","authenticated-orcid":false,"given":"Carol","family":"Tweed","sequence":"additional","affiliation":[{"name":"Anne Arundel Medical Center, Annapolis, MD"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mary","family":"Wilkinson","sequence":"additional","affiliation":[{"name":"Johns Hopkins University, Baltimore, MD"},{"name":"Inova Schar Cancer, Fairfax, VA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3706-3780","authenticated-orcid":false,"given":"Angela","family":"Pennisi","sequence":"additional","affiliation":[{"name":"Inova Schar Cancer, Fairfax, VA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bonnie","family":"Sun","sequence":"additional","affiliation":[{"name":"Johns Hopkins University, Baltimore, MD"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Pamela","family":"Wright","sequence":"additional","affiliation":[{"name":"Johns Hopkins University, Baltimore, MD"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3837-9928","authenticated-orcid":false,"given":"Julie R.","family":"Gralow","sequence":"additional","affiliation":[{"name":"Fred Hutchinson Cancer Center, University of Washington, Seattle, WA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2842-4476","authenticated-orcid":false,"given":"Richard","family":"Chen","sequence":"additional","affiliation":[{"name":"Personalis, Fremont, CA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sean M.","family":"Boyle","sequence":"additional","affiliation":[{"name":"Personalis, Fremont, CA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4018-4708","authenticated-orcid":false,"given":"Vered","family":"Stearns","sequence":"additional","affiliation":[{"name":"Johns Hopkins University, Baltimore, MD"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3734-1063","authenticated-orcid":false,"given":"Antonio C.","family":"Wolff","sequence":"additional","affiliation":[{"name":"Johns Hopkins University, Baltimore, MD"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8119-2291","authenticated-orcid":false,"given":"Ben Ho","family":"Park","sequence":"additional","affiliation":[{"name":"Vanderbilt University Medical Center, Nashville, TN"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"233","reference":[{"key":"e_1_3_12_2_2","doi-asserted-by":"publisher","DOI":"10.1093\/annonc\/mdu118"},{"key":"e_1_3_12_3_2","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(13)62422-8"},{"key":"e_1_3_12_4_2","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.22.02241"},{"key":"e_1_3_12_5_2","doi-asserted-by":"publisher","DOI":"10.1001\/jamaoncol.2022.3755"},{"key":"e_1_3_12_6_2","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.23.00435"},{"key":"e_1_3_12_7_2","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1612645"},{"key":"e_1_3_12_8_2","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa2406070"},{"key":"e_1_3_12_9_2","doi-asserted-by":"publisher","DOI":"10.1172\/JCI154941"},{"key":"e_1_3_12_10_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.ccell.2023.04.008"},{"key":"e_1_3_12_11_2","doi-asserted-by":"publisher","DOI":"10.1158\/1078-0432.CCR-24-3472"},{"key":"e_1_3_12_12_2","doi-asserted-by":"publisher","DOI":"10.1038\/s41467-025-57988-z"},{"key":"e_1_3_12_13_2","doi-asserted-by":"publisher","DOI":"10.1245\/s10434-010-0985-4"},{"key":"e_1_3_12_14_2","doi-asserted-by":"publisher","DOI":"10.18632\/oncotarget.28565"},{"key":"e_1_3_12_15_2","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa2409932"},{"key":"e_1_3_12_16_2","doi-asserted-by":"publisher","DOI":"10.1007\/s10549-025-07758-8"},{"key":"e_1_3_12_17_2","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1910549"},{"key":"e_1_3_12_18_2","doi-asserted-by":"publisher","DOI":"10.1038\/s41698-025-00876-y"},{"key":"e_1_3_12_19_2","doi-asserted-by":"publisher","DOI":"10.1186\/s13058-025-01986-y"},{"key":"e_1_3_12_20_2","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2025.43.16_suppl.1010"},{"key":"e_1_3_12_21_2","doi-asserted-by":"publisher","DOI":"10.1016\/S1470-2045(21)00589-1"}],"container-title":["Journal of Clinical Oncology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/ascopubs.org\/doi\/pdfdirect\/10.1200\/JCO-25-02934","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,5,6]],"date-time":"2026-05-06T21:59:26Z","timestamp":1778104766000},"score":1,"resource":{"primary":{"URL":"https:\/\/ascopubs.org\/doi\/10.1200\/JCO-25-02934"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,5,10]]},"references-count":20,"journal-issue":{"issue":"14","published-print":{"date-parts":[[2026,5,10]]}},"alternative-id":["10.1200\/JCO-25-02934"],"URL":"https:\/\/doi.org\/10.1200\/jco-25-02934","relation":{},"ISSN":["0732-183X","1527-7755"],"issn-type":[{"value":"0732-183X","type":"print"},{"value":"1527-7755","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,5,10]]},"assertion":[{"value":"2025-12-08","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2025-12-12","order":1,"name":"revised","label":"Revised","group":{"name":"publication_history","label":"Publication History"}},{"value":"2026-02-02","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2026-03-10","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}