A Study of Trastuzumab Emtansine Versus Capecitabine + Lapatinib in Participants With HER2-positive Locally Advanced or Metastatic Breast Cancer
Summary
This is a Phase III, randomized, multicenter, international, 2-arm, open-label clinical trial designed to compare the safety and efficacy of trastuzumab emtansine (T-DM1) with that of capecitabine + lapatinib in participants with human epidermal growth factor receptor 2 (HER2)-positive locally advanced or metastatic breast cancer. Participants will be treated until disease progression (PD), unmanageable toxicity, or study termination. Once disease progression is reported, all participants will be followed for survival every 3 months until death, loss to follow-up, withdrawal of consent, or study termination.
Timeline
- Start
- 2009-02
- Primary completion
- 2012-07
- Completion
- 2015-09
Outcome
Met primary endpoint
registry analysis (superiority or other test); Trastuzumab Emtansine vs Lapatinib + Capecitabine; p <0.0001; Hazard Ratio (HR) 0.650 (95% CI 0.549 to 0.771); Log Rank NCT00829166 ↗
registry analysis (superiority or other test); Trastuzumab Emtansine vs Lapatinib + Capecitabine; p = 0.0006; Hazard Ratio (HR) 0.682 (95% CI 0.548 to 0.849); Log Rank NCT00829166 ↗
paper CONCLUSIONS: T-DM1 significantly prolonged progression-free and overall survival with less toxicity than lapatinib plus capecitabine PMID 23020162 ↗
release “Roche has announced trastuzumab emtansine met the PFS endpoint in the lead Phase III trial, EMILIA.” abbvie.com ↗
release “Trastuzumab emtansine significantly improved overall survival (OS) as well as progression-free survival (PFS) in its lead Phase III trial, EMILIA.” abbvie.com ↗
Publications
- Dieras V, Miles D, Verma S, Pegram M, Welslau M, Baselga J, Krop IE, Blackwell K, Hoersch S, Xu J, Green M, Gianni L. Trastuzumab emtansine versus capecitabine plus lapatinib in patients with previously treated HER2-positive advanced breast cancer (EMILIA): a descriptive analysis of final overall survival results from a randomised, open-label, phase 3 trial. Lancet Oncol. 2017 Jun;18(6):732-742. doi: 10.1016/S1470-2045(17)30312-1. Epub 2017 May 16.
- Verma S, Miles D, Gianni L, Krop IE, Welslau M, Baselga J, Pegram M, Oh DY, Dieras V, Guardino E, Fang L, Lu MW, Olsen S, Blackwell K; EMILIA Study Group. Trastuzumab emtansine for HER2-positive advanced breast cancer. N Engl J Med. 2012 Nov 8;367(19):1783-91. doi: 10.1056/NEJMoa1209124. Epub 2012 Oct 1.
- Scott AM, Wolchok JD, Old LJ. Antibody therapy of cancer. Nat Rev Cancer. 2012 Mar 22;12(4):278-87. doi: 10.1038/nrc3236.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Capecitabine | Small molecule | 1000 mg/m2 | Oral |
| Comparator | Lapatinib | Small molecule | 1250 mg | Oral |
| Subject | Trastuzumab emtansine | Other / unclassified | 3.6 mg/kg | Intravenous |