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)
trastuzumab emtasine plus endocrine therapy
Harbeck (TDM1 plus ET), 2017
  NCT01817452		RCTes-BC - HER2 positive - (neo)adjuvant (NA), es-BC - HR positive - (neo)adjuvant (NA)trastuzumab emtasine plus endocrine therapytrastuzumab 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 eligible-/-NA
 suggested
  • suggested 3.0-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)
versus trastuzumab emtansine
trastuzumab deruxtecan
DESTINY Breast03, 2022
  NCT03529110		RCTla/mBC - HER2 positive - 2nd Line (L2)trastuzumab deruxtecantrastuzumab emtansinepatients with HER2-positive metastatic breast cancer previously treated with trastuzumab and a taxane-/-some concern
 suggested
  • suggested 45 % decrease in deaths (OS)
  • suggested 72 % decrease in progression or deaths (PFS)

 

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