6/28/23, 9:54 PM EMILIA Pathway Feedback Search Clinical Topics Home Studies EMILIA EMILIA Trial question What is the role of trastuzumab emtansine (T-DM1) in patients with HER2-positive advanced breast cancer? Study design Multi-center Open label RCT Population 991 female patients Inclusion criteria: patients with HER2-positive advanced breast cancer who had previously been treated with trastuzumab and a taxane Key exclusion criteria: prior treatment with T-DM1, lapatinib, or capecitabine; symptomatic CNS metastases or treatment for these metastases within 2 months before randomization; symptomatic congestive HF or serious cardiac arrhythmia requiring treatment; myocardial infarction or unstable angina within 6 months before randomization Interventions N=495 T-DM1 (trastuzumab emtansine 3.6 mg/kg of body weight IV every 21 days) N=496 lapatinib plus capecitabine (oral lapatinib at a dose of 1,250 mg daily plus oral capecitabine at a dose of 1,000 mg/m of body-surface area every 12h on days 1 through 14 of each 21-day treatment cycle) Primary outcome Median progression-free survival 9.6 months 9.6 7.2 months 6.4 4.8 months 2.4 months Significant increase 0.0 months T-DM1 Lapatinib plus capecitabine Significant increase in median progression-free survival (9.6 months vs. 6.4 months; HR 1.53, 95% CI 1.29 to 1.81) Secondary outcomes https://web.pathway.md/studies/rec2g0aQ5OJIUlAxi 1/2 6/28/23, 9:54 PM EMILIA Pathway Seco da y outco es Significant increase in median overall survival (30.9 vs. 25.1; HR 1.47, 95% CI 1.17 to 1.81) Significant increase in objective response (43.6% vs. 30.8%; ARD 12.7, 95% CI 6 to 19.4) Safety outcomes Significant difference in grade 3 or 4 adverse events (41% vs. 57%). Conclusion In patients with HER2-positive advanced breast cancer who had previously been treated with trastuzumab and a taxane, T-DM1 was superior to lapatinib plus capecitabine with respect to median progression-free survival. Reference Verma S, Miles D, Gianni L et al. Trastuzumab emtansine for HER2-positive advanced breast cancer. N Engl J Med. 2012 Nov 8;367(19):1783-91. Open reference URL https://web.pathway.md/studies/rec2g0aQ5OJIUlAxi 2/2