{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,24]],"date-time":"2026-10-24T19:36:03Z","timestamp":1792870563660,"version":"4.5.0"},"reference-count":24,"publisher":"American Medical Association (AMA)","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JAMA Oncol"],"abstract":"\n IMPORTANCE<\/jats:title>\n \n The combination of neoadjuvant taxanes with trastuzumab and pertuzumab remains the cornerstone treatment strategy in\n ERBB2<\/jats:italic>\n -positive breast cancer. Anbenitamab (a\n ERBB2<\/jats:italic>\n -biparatopic antibody that induces profound receptor clustering) and HB1801 (a solvent-free albumin-bound docetaxel), have shown promising antitumor activity and an acceptable safety profile in patients with breast cancer.\n <\/jats:p>\n <\/jats:sec>\n \n OBJECTIVE<\/jats:title>\n \n To evaluate whether neoadjuvant anbenitamab combined with HB1801 could improve efficacy without increasing toxic effects for patients with early\n ERBB2<\/jats:italic>\n -positive breast cancer.\n <\/jats:p>\n <\/jats:sec>\n \n DESIGN, SETTING, AND PARTICIPANTS<\/jats:title>\n \n This multicenter, phase 3 registrational randomized clinical trial enrolled patients with stage II or III\n ERBB2<\/jats:italic>\n -positive breast cancer from 61 hospitals in China between December 19, 2024, and August 29, 2025 (data cutoff: January 28, 2026). Data were analyzed from February 1 to March 20, 2026.\n <\/jats:p>\n <\/jats:sec>\n \n INTERVENTIONS<\/jats:title>\n Patients were randomly assigned (1:1) to receive 6 cycles of neoadjuvant anbenitamab plus HB1801, with or without carboplatin (investigational group), or trastuzumab, pertuzumab, and docetaxel, with or without carboplatin (control group).<\/jats:p>\n <\/jats:sec>\n \n MAIN OUTCOMES AND MEASURES<\/jats:title>\n The primary end point was total pathological complete response (tpCR) assessed by a blinded independent review committee.<\/jats:p>\n <\/jats:sec>\n \n RESULTS<\/jats:title>\n \n Among 521 included patients (median [IQR] age, 52.0 [23-79] years), 263 were randomized to the investigational group and 258 to the control group. The tpCR rate was significantly higher in the investigational group than the control group (164 patients [62.4%] vs 132 patients [51.2%]; absolute difference, 11.4 [95% CI, 3.2 to 19.6] percentage points;\n P<\/jats:italic>\n \u2009=\u2009.004). Benefit was consistent across subgroups, including subgroups with hormone receptor\u2013positive disease (77 patients [51.7%] vs 63 patients [44.4%]), hormone receptor\u2013negative disease (87 patients [76.3%] vs 69 patients [59.5%]), early-stage disease (111 patients [63.8%] vs 87 patients [51.8%]), locally advanced disease (53 patients [59.6%] vs 45 patients [50.0%]), with carboplatin treatment (74 patients [66.7%] vs 61 patients [54.5%]), and without carboplatin treatment (90 patients [59.2%] vs 71 patients [48.6%]). Grade 3 or 4 treatment-related adverse events occurred in 77 patients (29.3%) in the investigational group and 73 patients (28.3%) of the control group. No treatment-related deaths occurred.\n <\/jats:p>\n <\/jats:sec>\n \n CONCLUSIONS AND RELEVANCE<\/jats:title>\n This randomized clinical trial found that neoadjuvant anbenitamab and HB1801 in patients with breast cancer significantly improved the tpCR rate compared with standard therapy with a highly manageable safety profile. This new combination may offer an improved treatment option, although long-term survival follow-up analyses are warranted.<\/jats:p>\n <\/jats:sec>\n \n Trial Registration<\/jats:title>\n \n ClinicalTrials.gov Identifier:\n NCT06747338<\/jats:ext-link>\n <\/jats:p>\n <\/jats:sec>","DOI":"10.1001\/jamaoncol.2026.3329","type":"journal-article","created":{"date-parts":[[2026,9,3]],"date-time":"2026-09-03T16:03:50Z","timestamp":1788451430000},"source":"Crossref","is-referenced-by-count":2,"title":["Neoadjuvant Anbenitamab and HB1801 in\n ERBB2<\/i>\n -Positive Breast Cancer"],"prefix":"10.1001","author":[{"given":"Junjie","family":"Li","sequence":"first","affiliation":[{"name":"Department of Breast Surgery, Key Laboratory of Breast Cancer in Shanghai, Fudan University Shanghai Cancer Center, Shanghai, China"},{"name":"Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, 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