Study study type
PathologyT1T0Patientssample sizesROB Results

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

versus Standard of Care (SoC)
atezolizumab plus nab-paclitaxel
IMpassion-130 (all population), 2018
  NCT02425891		RCTmBC - TNBC - L1 - all populationatezolizumab plus nab-paclitaxelplacebo plus nab-paclitaxelpatients with untreated metastatic triple-negative breast cancer (TNBC) treated with nab-paclitaxel451 / 451low
 conclusif
  • inconclusive 14 % decrease in deaths (OS) (PE)
  • demonstrated 20 % decrease in progression or deaths (PFS) (PE)
  • suggested 20 % decrease in PFS (extension)
atezolizumab plus paclitaxel
IMpassion-131 (all population), 2020
  NCT03125902		RCTmBC - TNBC - L1 - all populationAtezolizumab plus paclitaxelplacebo plus paclitaxelPatients had metastatic or unresectable locally advanced measurable TNBC, had received no prior chemotherapy or targeted therapy for aTNBC and had completed any prior (neo)adjuvant chemotherapy for early breast cancer 12 months before being randomised to the trial.431 / 220NA
 inconclusive
  • inconclusive 14 % decrease in progression or deaths (PFS) (PE)
Atezolizumab (Tecentriq) in combination with paclitaxel did not demonstrate a statistically significant improvement in progression-free survival (PFS) as a first-line treatment for patients with PD-L1–positive triple-negative breast cancer (TNBC) / qualitative results only NO ROB

mBC - TNBC - L1 - PDL1 positive breast cancer - triple negative breast cancer - triple negative metastatic mBC - Triple negative (TNBC) - 1st Line (L1) mBC - TNBC - L1 - PDL1 positive

versus placebo plus SoC
atezolizumab plus SoC
IMpassion-132, 2024
  NCT03371017		RCTmBC - TNBC - L1 - PDL1 positiveatezolizumab plus SOCplacebo plus SOCPatients with locally advanced/metastatic TNBC recurring ≤12 months after completing standard (neo)adjuvant anthracycline and taxane chemotherapy or surgery in early stage297 / 298low
 inconclusive
  • inconclusive 7 % decrease in deaths (OS) (PE)
OS was not improved by adding atezolizumab to chemotherapy for rapidly relapsing PD-L1-positive TNBC
versus Standard of Care (SoC)
atezolizumab plus nab-paclitaxel
IMpassion-130 (PDL1>1%), 2018
  NCT02425891		RCTmBC - TNBC - L1 - PDL1 positiveatezolizumab plus nab-paclitaxelplacebo plus nab-paclitaxelpatients with untreated metastatic triple-negative breast cancer treated with nab-paclitaxel, and PDL1 positive population (>1%)185 / 184low
 conclusif
  • suggested 29 % decrease in deaths (OS) (PE)
  • demonstrated 38 % decrease in progression or deaths (PFS) (PE)
  • suggested 37 % decrease in PFS (extension)
atezolizumab plus paclitaxel
IMpassion-131 (PD-L1 > 1%), 2020
  NCT03125902		RCTmBC - TNBC - L1 - PDL1 positiveAtezolizumab plus paclitaxelplacebo plus paclitaxelPatients had metastatic or unresectable locally advanced measurable TNBC, had received no prior chemotherapy or targeted therapy for aTNBC and had completed any prior (neo)adjuvant chemotherapy for early breast cancer 12 months before being randomised to the trial.191 / 101NA
 inconclusive
  • inconclusive 18 % decrease in progression or deaths (PFS) (PE)

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 carboplatin plus nab-paclitaxel
atezolizumab plus carboplatin plus nab-paclitaxel
NeoTRIPaPDLA unpublished
  NCT02620280		RCTes-BC - TNBC - NA - all populationatezolizumab plus carboplatine plus nab-paclitaxelcarboplatine plus nab-paclitaxelNeoadjuvant Therapy in TRIPle Negative Breast Cancer (early or locally advanced)88 / 86NA
 inconclusive
    no statistically significant result
versus paclitaxel followed by doxorubicin plus cyclophosphamide
atezolizumab based treatment
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.
versus placebo plus SoC
atezolizumab plus nab-paclitxel followed by doxorubicin plus cyclophosphamide
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)

es-BC - TNBC - NA - PDL1 positive breast cancer - triple negative es-BC - Triple negatif (TNBC) - (neo)adjuvant (NA) es-BC - TNBC - NA - PDL1 positive

versus placebo plus SoC
atezolizumab plus nab-paclitxel followed by doxorubicin plus cyclophosphamide
IMpassion-031 (PDL1>1%), 2020
  NCT03197935		RCTes-BC - TNBC - NA - PDL1 positiveAtezolizumab 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 cancer with PDL1 >1%78 / 76low
 suggested
  • suggested 1.2-fold increase in pCR (PE)

 

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