Study study type PathologyT1T0Patientssample sizesROB Results

la/mBC - TNBC - L2 - all population breast cancer - triple negative breast cancer - triple negative metastatic mBC-Triple negative (TNBC) - 2nd Line (L2) la/mBC - TNBC - L2 - all population

versus Standard of Care (SoC)
pembrolizumab alone
KEYNOTE-119 (all population), 2019
  NCT02555657
RCTla/mBC - TNBC - L2 - all populationPembrolizumabchemotherapy (single agent)patients with previously treated metastatic triple negative breast cancer (mTNBC)312 / 310some concern
inconclusive
  • inconclusive 3 % decrease in deaths (OS) (PE)
  • statistically significant 60 % increase in progression or deaths (PFS)
  • statistically significant 40 % decrease in DCR
KEYNOTE-119 (all population) DUPLICATE, 2019
  NCT02555657
RCTla/mBC - TNBC - L2 - all populationPembrolizumabChemotherapyEligible participants were aged 18 years or older; had centrally confirmed metastatic triple-negative breast cancer; had received one or two previous systemic treatments for metastatic breast cancer, with documented disease progression on the most recent therapy; had receivedprevious treatment with an anthracycline or a taxane312 / 310low
inconclusive
  • inconclusive 3 % decrease in deaths (OS) (PE)
  • statistically significant 60 % increase in progression or deaths (PFS)
  • statistically significant 57 % decrease in DCR