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We aimed to assess the cCR rate in this trial and identify predictive factors.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>HER2-positivity was defined as an immunohistochemistry (IHC) score of 3\u2009+\u2009or in situ hybridization-positivity. A cCR was defined as the absence of detectable lesions upon palpation, contrast-enhanced magnetic resonance imaging, and ultrasonography; biopsy-based confirmation was optional in hormone receptor (HR)-negative cases and mandatory in HR-positive cases. Multivariate logistic regression analyses were used to identify predictors of a cCR.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>The cCR rate was 57.6% (196\/340 patients; 95% confidence interval [CI]: 52.2\u201363.0%). Strongly estrogen-receptor (ER)-positive tumors (\u2265\u200910%) were significantly less likely to have a cCR than ER-negative tumors (odds ratio [OR], 0.41; 95% CI: 0.20\u20130.81). IHC 3\u2009+\u2009tumors had higher cCR rates than IHC 1\u2009+\u2009or 2\u2009+\u2009tumors (OR, 2.19; 95% CI: 1.01\u20134.74). Compared with histological grade I tumors, cCR odds were higher in grade II (OR: 2.92; 95% CI: 1.07\u20137.93) and III (OR: 4.90; 95% CI: 1.76\u201313.7) tumors. Among patients without a cCR patients undergoing surgery, 22.2% were diagnosed with ypT0 tumors upon analysis of surgical specimens.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>ER-negativity, an IHC score of 3\u2009+\u2009, and a higher histological grade were independent predictors of a cCR. Identifying these features may improve the feasibility and safety of surgery omission for patients with HER2-positive early breast cancer.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1007\/s10147-026-02967-7","type":"journal-article","created":{"date-parts":[[2026,1,22]],"date-time":"2026-01-22T17:25:04Z","timestamp":1769102704000},"page":"528-536","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":4,"title":["Clinical complete response and predictive factors in HER2-positive early breast cancer treated with neoadjuvant chemotherapy aimed at omission of surgery: an exploratory analysis of the JCOG1806 trial"],"prefix":"10.1007","volume":"31","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-9393-9655","authenticated-orcid":false,"given":"Hideo","family":"Shigematsu","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tomomi","family":"Fujisawa","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fumikata","family":"Hara","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hiroji","family":"Iwata","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Toshiyuki","family":"Ishiba","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yukinori","family":"Ozaki","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Takehiko","family":"Sakai","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yasuaki","family":"Sagara","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Akihiko","family":"Shimomura","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kazuki","family":"Sudo","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kaori","family":"Terata","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yoichi","family":"Naito","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kazuki","family":"Nozawa","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Keita","family":"Sasaki","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Noriko","family":"Mitome","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ryo","family":"Sadachi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Taro","family":"Shibata","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tadahiko","family":"Shien","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2026,1,22]]},"reference":[{"issue":"9938","key":"2967_CR1","doi-asserted-by":"publisher","first-page":"164","DOI":"10.1016\/S0140-6736(13)62422-8","volume":"384","author":"P Cortazar","year":"2014","unstructured":"Cortazar P, Zhang L, Untch M et al (2014) Pathological complete response and long-term clinical benefit in breast cancer: the CTNeoBC pooled analysis. 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Fumikata Hara has received honoraria for lectures and presentations from Pfizer, Kyowa Kirin, Eli Lilly, Chugai Pharmaceutical, Daiichi Sankyo, MSD, and Gilead Sciences. Hiroji Iwata has received grants to his institution from Chugai Pharmaceutical, Daiichi Sankyo, and AstraZeneca; and has received consulting fees and honoraria for lectures and educational events from Daiichi Sankyo, Chugai Pharmaceutical, AstraZeneca, Eli Lilly, MSD, Pfizer, and Gilead Sciences. Yukinori Ozaki has received honoraria from Pfizer, Daiichi Sankyo, Eli Lilly, and Chugai Pharmaceutical. Yasuaki Sagara has received honoraria for lectures and presentations from Pfizer, AstraZeneca, Daiichi Sankyo, Eisai, Eli Lilly, Chugai Pharmaceutical, MSD, Nippon Kayaku, Kyowa Kirin, and Sysmex. Akihiko Shimomura has received research grants from Daiichi Sankyo, Pfizer, AstraZeneca, Gilead Sciences, Eisai, and MSD; and honoraria from AstraZeneca, Daiichi Sankyo, Pfizer, Eli Lilly, MSD, Chugai Pharmaceutical, Nihon Medi-physics, Taiho Pharmaceutical, and Exact Sciences (with honoraria exceeding \u00a5500,000 from AstraZeneca, Daiichi Sankyo, Pfizer, Eli Lilly, MSD, and Chugai Pharmaceutical). Youichi Naito has received grants to his institution from AbbVie, Ono, Daiichi Sankyo, Taiho Pharmaceutical, Pfizer, Boehringer Ingelheim, Eli Lilly, Eisai, AstraZeneca, Chugai Pharmaceutical, Bayer, Takeda, Anthos Therapeutics, and Gilead Sciences; and has received consulting fees and honoraria for lectures and educational events from AstraZeneca, Eisai, Gilead Sciences, Eli Lilly, Novartis, Pfizer, Chugai Pharmaceutical, Taiho, Bayer, Daiichi Sankyo, MSD, Ono, Guardant, PDR Pharma, Nihon Kayaku, and Bristol Myers Squibb. Kazuki Nozawa has received consulting fees from Pfizer and Chugai Pharmaceutical, and honoraria for lectures and educational events from Daiichi Sankyo, Chugai Pharmaceutical, Eli Lilly, MSD, and Pfizer. Tadahiko Shien has received honoraria for lectures and educational events from AstraZeneca, Novartis, MSD, Eisai, Taiho Pharmaceutical, Gilead Sciences, Pfizer, Chugai Pharmaceutical, Daiichi Sankyo, Takeda, Kyowa Kirin, and Eli Lilly. Motonobu Ozaki has received honoraria from Pfizer, Daiichi Sankyo, Eli Lilly, and Chugai Pharmaceutical. The following authors declare no conflicts of interest: Tomomi Fujisawa, Toshiyuki Ishiba, Takehiko Sakai, Kazuki Sudo, Kaori Terada, Keita Sasaki, Noriko Mitome, Ryo Sadachi, and Taro Shibata.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing Interests"}}]}}