Study study type PathologyT1T0Patientssample sizesROB Results

es-BC - HER2 positive - (neo)adjuvant (NA) breast cancer - HER2-positive es-BC - HER2 positive - (neo)adjuvant (NA)

versus trastuzumab
trastuzumab emtansine
KATHERINE, 2019
  NCT01772472
RCTes-BC - HER2 positive - (neo)adjuvant (NA)trastuzumab emtasine (T-DM1)trastuzumabPatients had histologically confirmed, HER2-positive, nonmetastatic, invasive primary breast cancer and if residual invasive disease after completion of taxane-based neoadjuvant chemotherapy ad and had to have completed at least six cycles (16 weeks) of a conventional preoperative chemotherapy regimen containing a minimum of 9 weeks of taxane-based therapy and 9 weeks of trastuzumab therapy.743 / 743high
conclusif
  • inconclusive 30 % decrease in deaths (OS) (PE)
  • demonstrated 50 % decrease in iDFS (PE)
versus trastuzumab plus endocrine therapy
trastuzumab emtansine
Harbeck (TDM-1), 2017 RCTes-BC - HER2 positive - (neo)adjuvant (NA), es-BC - HR positive - (neo)adjuvant (NA)trastuzumab emtasinetrastuzumab plus endocrine therapyWomen older than 18yr with histologically confirmed unilateral primary BC, no evidence of distant metastasis, ER and/or PR-positive and HER2-positive who were candidates for neoadjuvant chemotherapy were eligible119 / 129NA
suggested
  • suggested 2.9-fold increase in pCR (PE)

la/mBC - HER2 positive - 2nd Line (L2) breast cancer - HER2-positive la/mBC - HER2 positive la/mBC - HER2 positive - 2nd Line (L2)

versus lapatinib plus capecitabine
trastuzumab emtansine
EMILIA, 2012
  NCT00829166
RCTla/mBC - HER2 positive - 2nd Line (L2)trastuzumab emtansinelapatinib plus capecitabinepatients with HER2-positive unresectable, locally advanced or metastatic breast cancer, who had previously been treated with trastuzumab and a taxane.495 / 496some concern
conclusif
  • demonstrated 32 % decrease in deaths (OS) (PE)
  • demonstrated 35 % decrease in progression or deaths (PFS) (PE)
  • suggested 25 % decrease in deaths (OS) (extension)
  • demonstrated 73 % increase in objective responses (ORR) (PE)