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Hoffmann-La Roche Ltd.","doi-asserted-by":"crossref","id":[{"id":"10.13039\/100007013","id-type":"DOI","asserted-by":"crossref"}]}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Breast Cancer Res Treat"],"published-print":{"date-parts":[[2021,6]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Purpose<\/jats:title>\n                    <jats:p>Intravenous trastuzumab, pertuzumab, and docetaxel are first-line standard of care for patients with HER2-positive metastatic breast cancer (mBC). MetaPHER is the first study assessing the safety and tolerability of subcutaneous trastuzumab plus intravenous pertuzumab and chemotherapy in a global patient population with HER2-positive mBC.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>\n                      In this open-label, single-arm, multicenter, phase 3b study, eligible patients were\u2009\u2265\u200918\u00a0years old with histologically\/cytologically confirmed previously untreated HER2-positive mBC. All received\u2009\u2265\u20091 subcutaneous trastuzumab 600\u00a0mg fixed dose plus intravenous pertuzumab (loading dose: 840\u00a0mg\/kg; maintenance: 420\u00a0mg\/kg) and docetaxel (\u2265\u20096 cycles; initial dose 75\u00a0mg\/m\n                      <jats:sup>2<\/jats:sup>\n                      ) every 3\u00a0weeks. The primary objective was safety and tolerability; secondary objectives included efficacy.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>At clinical cutoff, 276 patients had completed the study; median duration of follow-up was 27\u00a0months. The most common any-grade adverse events were diarrhea, alopecia, and asthenia; the most common grade\u2009\u2265\u20093 events were neutropenia, febrile neutropenia, and hypertension. There were no cardiac deaths and mean left ventricular ejection fraction was stable over time. Median investigator-assessed progression-free survival was 18.7\u00a0months; objective response rate was 75.6%.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Safety and efficacy with subcutaneous trastuzumab plus intravenous pertuzumab and docetaxel in mBC are consistent with historical evidence of intravenous trastuzumab with this combination. Findings further support subcutaneous administration not affecting safety\/efficacy profiles of trastuzumab in HER2-positive BC with increased flexibility in patient care. A fixed-dose combination of pertuzumab and trastuzumab for subcutaneous injection has recently been approved for the treatment of HER2-positive early\/mBC, further addressing the increasing relevance of and need for patient-centric treatment strategies.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration<\/jats:title>\n                    <jats:p>NCT02402712<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1007\/s10549-021-06145-3","type":"journal-article","created":{"date-parts":[[2021,3,21]],"date-time":"2021-03-21T14:02:21Z","timestamp":1616335341000},"page":"467-476","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":21,"title":["Subcutaneous trastuzumab with pertuzumab and docetaxel in HER2-positive metastatic breast cancer: Final analysis of MetaPHER, a phase IIIb single-arm safety study"],"prefix":"10.1007","volume":"187","clinical-trial-number":[{"clinical-trial-number":"nct02402712","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-9355-494X","authenticated-orcid":false,"given":"Sherko","family":"Kuemmel","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Carlo A.","family":"Tondini","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jacinta","family":"Abraham","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Zbigniew","family":"Nowecki","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bartosz","family":"Itrych","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Erika","family":"Hitre","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bogus\u0142awa","family":"Karaszewska","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alejandro","family":"Ju\u00e1rez-Ramiro","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Flavia","family":"Morales-V\u00e1squez","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jose Manuel","family":"P\u00e9rez-Garc\u00eda","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Servando","family":"Cardona-Huerta","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Estefania","family":"Monturus","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marco","family":"Sequi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Eleonora","family":"Restuccia","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mark","family":"Benyunes","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Miguel","family":"Mart\u00edn","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2021,3,21]]},"reference":[{"key":"6145_CR1","doi-asserted-by":"publisher","first-page":"109","DOI":"10.1056\/NEJMoa1113216","volume":"366","author":"J Baselga","year":"2012","unstructured":"Baselga J, Cort\u00e9s J, Kim SB, Im SA, Hegg R, Im YH, Roman L, Pedrini JL, Pienkowski T, Knott A, Clark E, Benyunes MC, Ross G, Swain SM (2012) CLEOPATRA Study Group Pertuzumab plus trastuzumab plus docetaxel for metastatic breast cancer. 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Hoffmann-La Roche Ltd. Professor K\u00fcmmel has received consulting fees from F. Hoffmann-La Roche Ltd, Genomic Health, Novartis, Amgen, Celgene, Daiichi Sankyo, AstraZeneca, Somatex, Merck Sharp & Dohme, Pfizer, PUMA Biotechnology, and PFM Medical, and has received non-financial support outside the submitted work for a travel grant from F. Hoffmann-La Roche Ltd, Daiichi Sankyo, and SonoScape. Dr. Tondini has received an institutional grant from ASST Papa Giovanni XXIII for participation in the MetaPHER study, and institutional grants for participation in other clinical trials from F. Hoffmann-La Roche Ltd, Novartis, Merck Sharp & Dohme, Bristol Myers Squibb, AstraZeneca, and Array BioPharma, Inc. Dr. Abraham has received personal fees for conference participation from Eisai, and personal fees for an advisory board from Merck & Co, Inc. Dr. Nowecki has received a travel grant from F. Hoffmann-La Roche Ltd. Dr. Itrych has no other conflicts to disclose. Dr. Hitre has received research funding and non-financial support (i.e., drugs) outside the submitted work from F. Hoffmann-La Roche Ltd. Dr. Karaszewska has received research grants from F. Hoffmann-La Roche Ltd, Novartis, Merck & Co, Inc., and Amgen. Dr. Ju\u00e1rez-Ramiro has received fees for clinical research from F. Hoffmann-La Roche Ltd, Bristol Myers Squibb, Merck Sharp & Dohme, Bayer, Pfizer, and Amgen, and personal speaker fees from F. Hoffmann-La Roche Ltd, Bristol Myers Squibb, Merck Serono, Bayer, and Amgen. Dr. Morales-V\u00e1squez has received consulting fees from F. Hoffmann-La Roche Ltd, AstraZeneca, and Asofarma. Dr. P\u00e9rez Garc\u00eda has received personal fees for an advisory board and travel grants from F. Hoffmann-La Roche Ltd, and has received personal fees for an advisory board from Lilly. Dr. Cardona-Huerta has received consulting fees from F. Hoffmann-La Roche Ltd and AstraZeneca. Dr. Monturus is an employee of F. Hoffmann-La Roche Ltd (author and spouse\/partner) and has stock\/ownership interest in F. Hoffmann-La Roche Ltd\/Genentech, Inc. (author and spouse\/partner). Dr. Sequi is an employee of PAREXEL and is contracted by F. Hoffmann-La Roche Ltd. Dr. Restuccia is an employee of F. Hoffmann-La Roche Ltd and has stock\/ownership interest in F. Hoffmann-La Roche Ltd. Dr. Benyunes is an employee of Genentech, Inc. Dr. Mart\u00edn has received research grants and personal fees from F. Hoffmann-La Roche Ltd, PUMA, and Novartis, consulting\/advisory fees from AstraZeneca, Amgen, Taiho Oncology, F. Hoffmann-La Roche Ltd\/Genentech, Inc., Novartis, PharmaMar, Eli Lilly, PUMA, Daiichi Sankyo, and Pfizer.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict 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":"All patients provided written informed consent.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent to participate"}}]}}