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Hoffmann-La Roche","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100007013","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Int J Clin Oncol"],"published-print":{"date-parts":[[2026,7]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>\n                      Neoadjuvant fixed-dose combination of pertuzumab and trastuzumab for subcutaneous injection (PH FDC SC) demonstrated non-inferior cycle 7 pertuzumab and trastuzumab serum trough concentrations (C\n                      <jats:sub>trough<\/jats:sub>\n                      ), and similar total pathological complete response (tpCR) rates and safety, to intravenous pertuzumab plus trastuzumab (P\u2009+\u2009H IV) in HER2-positive early breast cancer (eBC). In the FDChina study (NCT04024462), we assessed neoadjuvant\u2013adjuvant PH FDC SC vs. P\u2009+\u2009H IV in Chinese patients with HER2-positive eBC.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>\n                      Patients received four doxorubicin (60\u00a0mg\/m\n                      <jats:sup>2<\/jats:sup>\n                      ) plus cyclophosphamide (600\u00a0mg\/m\n                      <jats:sup>2<\/jats:sup>\n                      ), then four docetaxel (75\u2013100\u00a0mg\/m\n                      <jats:sup>2<\/jats:sup>\n                      ) cycles, every 3\u00a0weeks. Patients were randomized 1:1 to PH FDC SC (loading: 1200\u00a0mg pertuzumab\/600\u00a0mg trastuzumab; maintenance: 600\u00a0mg\/600\u00a0mg) or P\u2009+\u2009H IV (loading: 840\u00a0mg\/8\u00a0mg\/kg; maintenance: 420\u00a0mg\/6\u00a0mg\/kg) alongside docetaxel before surgery. Patients then continued HER2-targeted therapy for 14 cycles. Co-primary non-inferiority endpoints: cycle 7 pertuzumab and trastuzumab C\n                      <jats:sub>trough<\/jats:sub>\n                      . Secondary endpoints: tpCR, long-term efficacy, safety.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>The lower bounds of the 90% confidence intervals of pertuzumab and trastuzumab cycle 7 geometric mean ratios (0.99 and 1.44, respectively) exceeded the pre-specified non-inferiority margin (0.8). tpCR rates were 55.6% for PH FDC SC vs. 56.4% for P\u2009+\u2009H IV. Grade\u2009\u2265\u20093 adverse events occurred in 72% vs. 69% of patients.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>\n                      The study met the co-primary endpoints of non-inferiority of cycle 7 serum C\n                      <jats:sub>trough<\/jats:sub>\n                      for pertuzumab and trastuzumab for PH FDC SC vs. P\u2009+\u2009H IV. tpCR rates and safety were comparable between arms. PH FDC SC may be a viable treatment option for Chinese patients with HER2-positive eBC.\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1007\/s10147-025-02935-7","type":"journal-article","created":{"date-parts":[[2026,5,7]],"date-time":"2026-05-07T15:41:52Z","timestamp":1778168512000},"page":"1189-1200","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":2,"title":["The fixed-dose combination of pertuzumab and trastuzumab for subcutaneous injection in Chinese patients with HER2-positive early breast cancer: primary analysis of the phase III, randomized FDChina study"],"prefix":"10.1007","volume":"31","author":[{"given":"Tao","family":"Huang","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Zhimin","family":"Fan","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yongsheng","family":"Wang","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xi","family":"Yan","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hongjian","family":"Yang","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shu","family":"Wang","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Da","family":"Pang","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Huiping","family":"Li","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Haibo","family":"Wang","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Cuizhi","family":"Geng","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Liang","family":"Huang","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yaqing","family":"Sun","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bei","family":"Wang","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Guofang\u00a0","family":"Sun","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Asna","family":"Siddiqui","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Eleonora","family":"Restuccia","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Zhimin","family":"Shao","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2026,5,7]]},"reference":[{"key":"2935_CR1","doi-asserted-by":"publisher","first-page":"519","DOI":"10.1016\/s1470-2045(19)30863-0","volume":"21","author":"SM Swain","year":"2020","unstructured":"Swain SM, Miles D, Kim SB et al (2020) Pertuzumab, trastuzumab, and docetaxel for HER2-positive metastatic breast cancer (CLEOPATRA): end-of-study results from a double-blind, randomised, placebo-controlled, phase 3 study. 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Hoffmann-La Roche Ltd. Yaqing Sun is an employee of Roche (China) Holding Co. Ltd. Guofang Sun is an employee of Roche (China) Holding Co. Ltd and holds stocks\/shares in F. Hoffmann-La Roche Ltd. Bei Wang is an employee of Genentech, Inc. and holds stocks\/shares in F. Hoffmann-La Roche Ltd. Asna Siddiqui is an employee of Roche Products Limited and holds stocks\/shares in F. Hoffmann-La Roche Ltd. Eleonora Restuccia is an employee of and holds stocks\/shares in F. Hoffmann-La Roche Ltd. Non-financial interests: All authors received research funding in the form of third-party medical writing assistance for this manuscript from F. Hoffmann-La Roche Ltd.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflicts of interest"}},{"value":"The study was performed in accordance with the Declaration of Helsinki and Good Clinical Practice guidelines. Approval for the study protocol and all accompanying material provided to patients was obtained from independent ethics committees at participating institutions.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethical approval"}},{"value":"Informed consent was obtained from all individual participants involved in the study.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Informed consent"}}]}}