Clinical trials

EMILIA study (Metastatic HER2+ breast cancer)

The EMILIA study was a randomised Phase III clinical trial that took place from February 2009 to October 2011 which compared the treatment of 991 patients with HER2+ unresectable advanced or metastatic breast cancer who had already been treated with trastuzumab and a taxane. The trial measured the responses to a treatment of either 3.6 mg Kadcyla/kg bodyweight intravenously every 3 weeks in the Kadcyla group or a treatment of capecitabine and lapatinib in the control group (Diéras et al., 2017).

The EMILIA study reported that trastuzumab emtansine improved overall survival in patients with previously treated HER2+ metastatic breast cancer when compared to treatment with capecitabine and lapatinib.

This clinical trial influenced the decision of many regulatory bodies to grant marketing authorisation to Genentech/Roche in 2013 for Kadcyla.

KATHERINE study (Early HER2+ breast cancer)

The KATHERINE study (Von Minckwitz et al., 2019) was a randomised, Phase III clinical trial that took place from April 2013 through December 2015 which focused on the treatment of patients with HER2-positive early breast cancer who still had invasive disease after receiving therapy with a taxane and trastuzumab. This clinical trial compared the effectiveness of adjuvant Trastuzumab-DM1 (T-DM1)/Kadcyla with that of trastuzumab/Herceptin in treating HER2-positive early breast cancer.

The trial was conducted with 1486 patients from 28 countries who were randomly assigned to two groups; 743 patients were treated using T-DM1 and another 743 were treated using trastuzumab alone. Those treated with T-DM1 were given a dose of 3.6 mg T-DM1/kg body weight and the trastuzumab group received a dose of 6 mg trastuzumab/kg body weight. These doses were administered intravenously every 3 weeks for 14 cycles.

The trial showed that patients treated with adjuvant T-DM1 had a 50% lower chance of developing recurrent invasive breast cancer or death when compared to those treated with trastuzumab alone.

The KATHERINE study shaped the FDA’s May 2019 decision to extend the approval of Kadcyla for the adjuvant treatment of patients with HER2+ early breast cancer who have residual invasive disease following treatment with trastuzumab and a taxane (Wedam et al., 2020)