Examining the KAMILLA Trial of Trastuzumab Emtansine in Metastatic Breast Cancer

Rachel Wuerstein, MD, of the Unïversität Müchen, discusses the KAMILLA trial (NCT01702571) of trastuzumab emtansine (T-DM1) in metastatic breast cancer for both a global and Asian cohort.

The 2-cohort, open-label, multicenter KAMILLA trial was created to look at the safety and efficacy of T-DM1 in these patient populations. Over 2000 patients were included in the trial and 182 were in the Asian cohort.

Patients were required to be aged 18 years and older with HER2-positive disease determined locally, histologically or cytologically confirmed invasive breast cancer, prior treatment for breast cancer in the adjuvant, unresectable, locally advanced or metastatic setting with both chemotherapy, alone or in combination with another agent, and an anti-HER2 agent, alone or in combination with another agent, measurable and/or non-measurable disease, an ECOG performance status of 0,1 or 2, and adequate organ function.

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0:08 | KAMILLA was the safety and efficacy trial for a global and Asian cohort. It was of high importance because there was actually a need to get more safety data for T-DM1 (for patients with) metastatic breast cancer at the time. KAMILLA focused on a global cohort with large patient numbers, but also—and that’s of special interest—on an Asian cohort.

0:43 | Included in the KAMILLA trial is the highest number of patients entering a trial for T-DM1…more than 2000 patients in the global cohort and 182 patients in the Asian cohort. Ultimately, the reason for this trial at the time was the need for more safety data of this new track, which, in the meantime, got standard of care for second- or first-line treatment in HER2+ metastatic breast cancer.