Study study type PathologyT1T0Patientssample sizesROB Results

mBC - Triple negative (TNBC) - 1st Line (L1) breast cancer - triple negative breast cancer - triple negative metastatic mBC - Triple negative (TNBC) - 1st Line (L1)

versus nab-paclitaxel, placebo
nab-paclitaxel
TORCHLIGHT, 2024
  NCT04085276
RCTmBC - Triple negative (TNBC) - 1st Line (L1)toripalimab and nab-paclitaxelplacebo and nab-PPatients aged at least 18 years with histologically confirmed TNBC, previously untreated or no more than one previous systemic chemotherapy regimen for stage IV or locally advanced TNBC that is not amenable to surgery353 / 178low
inconclusive
  • suggested 31 % decrease in deaths (OS)
  • suggested 23 % decrease in progression or deaths (PFS) (PE)
  • statistically significant 73 % increase in SAE (grade 3-4)

es-BC - TNBC - NA - all population breast cancer - triple negative es-BC - Triple negatif (TNBC) - (neo)adjuvant (NA) es-BC - TNBC - NA - all population

versus paclitaxel followed by doxorubicin plus cyclophosphamide
paclitaxel followed by doxorubicin plus cyclophosphamide
ALEXANDRA/IMpassion-030, 2024
  NCT03498716
RCTes-BC - TNBC - NA - all populationatezolizumab plus chemotherapychemotherapyPatients with newly diagnosed Stage II-III (es) primary invasive Breast cancer (BC) that is of triple negative phenotype and who were to be treated with adjuvant systemic chemotherapy following definitive surgery,1101 / 1098NA
inconclusive
  • inconclusive 11 % increase in iDFS (PE)
  • statistically significant 81 % increase in SAE (any grade)
At the final analysis, the addition of atezo to adjuvant anthracycline- and taxane-based chemo did not improve iDFS in the ITT population of stage II-III TNBC or in any of the subgroups interrogated. Safety data remain consistent with the known profile of atezo in early TNBC.