Study study type PathologyT1T0Patientssample sizesROB Results

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 placebo plus SoC
atezolizumab plus SoC
IMpassion-031 (all population), 2020
  NCT03197935
RCTes-BC - TNBC - NA - all populationAtezolizumab plus nab-paclitaxel followed by doxorubicin and cyclophosphamide with filgrastim or pegfilgrastim supportplacebo plus nab-paclitaxel followed by doxorubicin and cyclophosphamide with filgrastim or pegfilgrastim supportneoadjuvant setting in participants with early stage (stage II-III) triple negative breast cancer165 / 168low
conclusif
  • demonstrated 95 % increase in pCR (PE)
versus Standard of Care (SoC)
atezolizumab plus SoC
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)
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.
NeoTrip Michel Angelo, 2022
  NCT02620280
RCTes-BC - TNBC - NA - all populationatezolizumab plus SOCSOCpatients with previously untreated histologically confirmed unilateral triple negative breast cancer, early high risk versus locally advanced. Pts with metastatic disease (stage IV) were excluded.138 / 142some concern
inconclusive
    no statistically significant result
The addition of atezolizumab to nab-paclitaxel and carboplatin did not significantly increase the rate of pCR in women with TNBC. In multivariate analysis, the presence of PD-L1 expression was the most significant factor influencing the rate of pCR (OR 2.08).