{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,5]],"date-time":"2026-10-05T14:59:36Z","timestamp":1791212376502,"version":"4.1.0"},"reference-count":33,"publisher":"American Society of Clinical Oncology (ASCO)","issue":"26","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JCO"],"published-print":{"date-parts":[[2012,9,10]]},"abstract":"<jats:sec><jats:title>Purpose<\/jats:title><jats:p> To determine whether the antibody-drug conjugate trastuzumab emtansine (T-DM1), which combines human epidermal growth factor receptor 2 (HER2) \u2013targeted delivery of the potent antimicrotubule agent DM1 with the antitumor activity of trastuzumab, is effective in patients with HER2-positive metastatic breast cancer (MBC) who have previously received all standard HER2-directed therapies. <\/jats:p><\/jats:sec><jats:sec><jats:title>Patients and Methods<\/jats:title><jats:p> In this single-arm phase II study, T-DM1 3.6 mg\/kg was administered intravenously every 3 weeks to patients with HER2-positive MBC who had prior treatment with trastuzumab, lapatinib, an anthracycline, a taxane, and capecitabine. The primary objectives were overall response rate (ORR) by independent review and safety. <\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p> Among 110 pretreated patients (median, seven prior agents for MBC; median follow-up, 17.4 months), the ORR was 34.5% (95% CI, 26.1% to 43.9%), clinical benefit rate was 48.2% (95% CI, 38.8% to 57.9%), median progression-free survival (PFS) was 6.9 months (95% CI, 4.2 to 8.4 months), and median duration of response was 7.2 months (95% CI, 4.6 months to not estimable). In patients with confirmed HER2-positive tumors (n = 80 by retrospective central testing), the response rate was 41.3% (95% CI, 30.4% to 52.8%), and median PFS was 7.3 months (95% CI, 4.6 to 12.3 months). Most adverse events were grades 1 to 2; the most frequent grade \u2265 3 events were thrombocytopenia (9.1%), fatigue (4.5%), and cellulitis (3.6%). <\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p> T-DM1 is well tolerated and has single-agent activity in patients with HER2-positive MBC who have previously received both approved HER2-directed therapies and multiple chemotherapy agents. T-DM1 may be an effective new treatment for this patient population. <\/jats:p><\/jats:sec>","DOI":"10.1200\/jco.2011.40.5902","type":"journal-article","created":{"date-parts":[[2012,5,30]],"date-time":"2012-05-30T05:36:44Z","timestamp":1338356204000},"page":"3234-3241","source":"Crossref","is-referenced-by-count":318,"title":["A Phase II Study of Trastuzumab Emtansine in Patients With Human Epidermal Growth Factor Receptor 2\u2013Positive Metastatic Breast Cancer Who Were Previously Treated With Trastuzumab, Lapatinib, an Anthracycline, a Taxane, and Capecitabine"],"prefix":"10.1200","volume":"30","author":[{"given":"Ian E.","family":"Krop","sequence":"first","affiliation":[{"name":"Ian E. Krop and Eric P. Winer, Dana-Farber Cancer Institute, Boston, MA; Patricia LoRusso, Karmanos Cancer Institute, Detroit, MI; Kathy D. Miller, Indiana University Melvin and Bren Simon Cancer Center, Indianapolis, IN; Shanu Modi, Memorial Sloan-Kettering Cancer Center, New York, NY; Denise Yardley, Sarah Cannon Research Institute; Tennessee Oncology, Nashville, TN; Gladys Rodriguez, South Texas Oncology\/Hematology, San Antonio, TX; Ellie Guardino, Michael Lu, Maoxia Zheng, Sandhya Girish, and Lukas..."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Patricia","family":"LoRusso","sequence":"additional","affiliation":[{"name":"Ian E. Krop and Eric P. Winer, Dana-Farber Cancer Institute, Boston, MA; Patricia LoRusso, Karmanos Cancer Institute, Detroit, MI; Kathy D. Miller, Indiana University Melvin and Bren Simon Cancer Center, Indianapolis, IN; Shanu Modi, Memorial Sloan-Kettering Cancer Center, New York, NY; Denise Yardley, Sarah Cannon Research Institute; Tennessee Oncology, Nashville, TN; Gladys Rodriguez, South Texas Oncology\/Hematology, San Antonio, TX; Ellie Guardino, Michael Lu, Maoxia Zheng, Sandhya Girish, and Lukas..."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kathy D.","family":"Miller","sequence":"additional","affiliation":[{"name":"Ian E. Krop and Eric P. Winer, Dana-Farber Cancer Institute, Boston, MA; Patricia LoRusso, Karmanos Cancer Institute, Detroit, MI; Kathy D. Miller, Indiana University Melvin and Bren Simon Cancer Center, Indianapolis, IN; Shanu Modi, Memorial Sloan-Kettering Cancer Center, New York, NY; Denise Yardley, Sarah Cannon Research Institute; Tennessee Oncology, Nashville, TN; Gladys Rodriguez, South Texas Oncology\/Hematology, San Antonio, TX; Ellie Guardino, Michael Lu, Maoxia Zheng, Sandhya Girish, and Lukas..."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shanu","family":"Modi","sequence":"additional","affiliation":[{"name":"Ian E. Krop and Eric P. Winer, Dana-Farber Cancer Institute, Boston, MA; Patricia LoRusso, Karmanos Cancer Institute, Detroit, MI; Kathy D. Miller, Indiana University Melvin and Bren Simon Cancer Center, Indianapolis, IN; Shanu Modi, Memorial Sloan-Kettering Cancer Center, New York, NY; Denise Yardley, Sarah Cannon Research Institute; Tennessee Oncology, Nashville, TN; Gladys Rodriguez, South Texas Oncology\/Hematology, San Antonio, TX; Ellie Guardino, Michael Lu, Maoxia Zheng, Sandhya Girish, and Lukas..."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Denise","family":"Yardley","sequence":"additional","affiliation":[{"name":"Ian E. Krop and Eric P. Winer, Dana-Farber Cancer Institute, Boston, MA; Patricia LoRusso, Karmanos Cancer Institute, Detroit, MI; Kathy D. Miller, Indiana University Melvin and Bren Simon Cancer Center, Indianapolis, IN; Shanu Modi, Memorial Sloan-Kettering Cancer Center, New York, NY; Denise Yardley, Sarah Cannon Research Institute; Tennessee Oncology, Nashville, TN; Gladys Rodriguez, South Texas Oncology\/Hematology, San Antonio, TX; Ellie Guardino, Michael Lu, Maoxia Zheng, Sandhya Girish, and Lukas..."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gladys","family":"Rodriguez","sequence":"additional","affiliation":[{"name":"Ian E. Krop and Eric P. Winer, Dana-Farber Cancer Institute, Boston, MA; Patricia LoRusso, Karmanos Cancer Institute, Detroit, MI; Kathy D. Miller, Indiana University Melvin and Bren Simon Cancer Center, Indianapolis, IN; Shanu Modi, Memorial Sloan-Kettering Cancer Center, New York, NY; Denise Yardley, Sarah Cannon Research Institute; Tennessee Oncology, Nashville, TN; Gladys Rodriguez, South Texas Oncology\/Hematology, San Antonio, TX; Ellie Guardino, Michael Lu, Maoxia Zheng, Sandhya Girish, and Lukas..."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ellie","family":"Guardino","sequence":"additional","affiliation":[{"name":"Ian E. Krop and Eric P. Winer, Dana-Farber Cancer Institute, Boston, MA; Patricia LoRusso, Karmanos Cancer Institute, Detroit, MI; Kathy D. Miller, Indiana University Melvin and Bren Simon Cancer Center, Indianapolis, IN; Shanu Modi, Memorial Sloan-Kettering Cancer Center, New York, NY; Denise Yardley, Sarah Cannon Research Institute; Tennessee Oncology, Nashville, TN; Gladys Rodriguez, South Texas Oncology\/Hematology, San Antonio, TX; Ellie Guardino, Michael Lu, Maoxia Zheng, Sandhya Girish, and Lukas..."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael","family":"Lu","sequence":"additional","affiliation":[{"name":"Ian E. Krop and Eric P. Winer, Dana-Farber Cancer Institute, Boston, MA; Patricia LoRusso, Karmanos Cancer Institute, Detroit, MI; Kathy D. 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Miller, Indiana University Melvin and Bren Simon Cancer Center, Indianapolis, IN; Shanu Modi, Memorial Sloan-Kettering Cancer Center, New York, NY; Denise Yardley, Sarah Cannon Research Institute; Tennessee Oncology, Nashville, TN; Gladys Rodriguez, South Texas Oncology\/Hematology, San Antonio, TX; Ellie Guardino, Michael Lu, Maoxia Zheng, Sandhya Girish, and Lukas..."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sandhya","family":"Girish","sequence":"additional","affiliation":[{"name":"Ian E. Krop and Eric P. Winer, Dana-Farber Cancer Institute, Boston, MA; Patricia LoRusso, Karmanos Cancer Institute, Detroit, MI; Kathy D. 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