{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,18]],"date-time":"2026-08-18T01:50:59Z","timestamp":1787017859380,"version":"build-2736575974"},"reference-count":17,"publisher":"Wiley","issue":"1","license":[{"start":{"date-parts":[[2026,4,20]],"date-time":"2026-04-20T00:00:00Z","timestamp":1776643200000},"content-version":"vor","delay-in-days":109,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"},{"start":{"date-parts":[[2026,1,1]],"date-time":"2026-01-01T00:00:00Z","timestamp":1767225600000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["International Journal of Breast Cancer"],"published-print":{"date-parts":[[2026,1]]},"abstract":"<jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Trastuzumab emtansine (T\u2010DM1) represents an advancement in HER2\u2010targeted therapy, offering a unique combination of trastuzumab\u2032s specificity and the cytotoxic potency of maytansine. It demonstrates therapeutic efficacy across the spectrum of breast cancer, including both early\u2010stage and advanced disease. With the emergence of biosimilar formulations, there is a growing need to generate real\u2010world evidence supporting their clinical performance. This study investigates the effectiveness and safety of a T\u2010DM1 biosimilar in routine oncology practice across adjuvant and metastatic HER2\u2010positive breast cancer populations.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>In this prospective, single\u2010institute study conducted at a tertiary oncology center in India, 116 patients with HER2\u2010positive breast cancer (51 adjuvant and 65 metastatic) received T\u2010DM1 biosimilar (Ujvira) between June 2021 and October 2023. Outcomes assessed included overall response rate (ORR), progression\u2010free survival (PFS), overall survival (OS), and treatment\u2010emergent adverse events (AEs), graded using CTCAE v5.0.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>In the metastatic cohort, ORR was 63.4%, median PFS was 8.0 months (95% CI: 5.8\u201310.2), and estimated median OS was 18.0 months (95% CI: 16.1\u201319.9). Clinical benefit rate was 75%. In the adjuvant cohort, 62.7% completed the planned 14 cycles, and treatment was well tolerated. Grade \u2265\u20093 AEs occurred in 6.9% of all patients, with fatigue and thrombocytopenia being the most common AEs. No unexpected safety signals were observed.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>T\u2010DM1 biosimilar showed outcomes consistent with those reported for the originator in real\u2010world settings, supporting its broader adoption in both early and advanced HER2\u2010positive breast cancer. Its affordability may improve access and outcomes in resource\u2010limited settings.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1155\/ijbc\/8863217","type":"journal-article","created":{"date-parts":[[2026,4,21]],"date-time":"2026-04-21T06:29:21Z","timestamp":1776752961000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["Real\u2010World Safety and Efficacy of Biosimilar Trastuzumab Emtansine (T\u2010DM1) in HER2\u2010Positive Breast Cancer: A Prospective Single\u2010Institution Study From India"],"prefix":"10.1155","volume":"2026","author":[{"ORCID":"https:\/\/orcid.org\/0009-0007-5903-2225","authenticated-orcid":false,"given":"Divya","family":"Gandrala","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5597-756X","authenticated-orcid":false,"given":"Senthil J.","family":"Rajappa","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Krishnamohan","family":"Mallavarapu","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8333-6161","authenticated-orcid":false,"given":"A.","family":"Santa","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0008-9257-2925","authenticated-orcid":false,"given":"B.","family":"Pavan Kumar","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0007-9412-6155","authenticated-orcid":false,"given":"Rakesh","family":"Pinninti","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Pallavi S.","family":"Ladda","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4570-2028","authenticated-orcid":false,"given":"Nikhil","family":"Pathi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sanath","family":"Kandem","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0004-1024-185X","authenticated-orcid":false,"given":"Rohan Kamlesh","family":"Tewani","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2781-9898","authenticated-orcid":false,"given":"Vipulkumar","family":"Thummar","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0886-9670","authenticated-orcid":false,"given":"Priya","family":"Mehta","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2026,4,20]]},"reference":[{"key":"e_1_2_10_1_2","doi-asserted-by":"publisher","DOI":"10.1111\/bcp.12044"},{"key":"e_1_2_10_2_2","doi-asserted-by":"publisher","DOI":"10.2471\/BLT.19.024135"},{"key":"e_1_2_10_3_2","doi-asserted-by":"publisher","DOI":"10.7759\/cureus.103700"},{"key":"e_1_2_10_4_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.clbc.2021.11.006"},{"key":"e_1_2_10_5_2","doi-asserted-by":"publisher","DOI":"10.6004\/jnccn.2013.0098"},{"key":"e_1_2_10_6_2","doi-asserted-by":"publisher","DOI":"10.18231\/j.joapr.2024.12.2.35.41"},{"key":"e_1_2_10_7_2","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1814017"},{"key":"e_1_2_10_8_2","volume-title":"National Cancer Institute. 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