Study study type
PathologyT1T0Patientssample sizesROB Results

mBC - Triple negative (TNBC) - (neo)adjuvant (NA) breast cancer - triple negative breast cancer - triple negative metastatic mBC - Triple negative (TNBC) - (neo)adjuvant (NA)

versus carboplatin, pegylated liposomal doxorubicin and cyclophosphamide
atezolizumab based treatment
NSABP B-59/GBG 96-GeparDouze, 2018
  NCT03281954		RCTmBC - Triple negative (TNBC) - (neo)adjuvant (NA)atezolizumab plus NAC (neoadjuvant chemotherapy)placebo plus NACPatients with centrally-confirmed ER-neg, PR-neg, HER2-neg invasive breast cancer by ASCO/CAP guidelines, stage T2 or T3 if cN0 or cN1 with negative biopsy or T1c, T2, or T3 if cN1 with positive biopsy or cN2 or cN3. LVEF > 55% and no significant cardiac history773 / 777NA
 inconclusive
  • inconclusive 20 % decrease in events or deaths (EFS) (PE)

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

versus nab-paclitaxel
atezolizumab plus nab-paclitaxel
IMpassion-130 (all population), 2018
  NCT02425891		RCTla/mBC - 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)
versus paclitaxel
atezolizumab plus paclitaxel
IMpassion-131 (all population), 2020
  NCT03125902		RCTla/mBC - 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 / 220low
 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

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

versus nab-paclitaxel
atezolizumab plus nab-paclitaxel
IMpassion-130 (PDL1>1%), 2018
  NCT02425891		RCTla/mBC - 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)
versus paclitaxel
atezolizumab plus paclitaxel
IMpassion-131 (PD-L1 > 1%), 2020
  NCT03125902		RCTla/mBC - 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 / 101low
 inconclusive
  • inconclusive 18 % decrease in progression or deaths (PFS) (PE)

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 carboplatin, gemcitabine
atezolizumab based treatment
IMpassion-132 (ITT population), 2024
  NCT03371017		RCTla/mBC - TNBC - L2 - all populationatezolizumab 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
    no statistically significant result
OS was not improved by adding atezolizumab to chemotherapy for rapidly relapsing PD-L1-positive TNBC
versus carboplatin
atezolizumab based treatment
TBCRC, 2024

  NCT03206203		RCTla/mBC - TNBC - L2 - all populationcarboplatin atezolizumab, 1200 mgcarboplatinclinical stage IV or metastatic invasive TN breast cancer. 0 to 1 prior treatments for metastatic disease, and no prior carboplatin in the metastatic setting or prior immune-oncology treatment were eligible. Patients were not stratified by PD-L1 status.56 / 50high
 inconclusive
  • suggested 54 % decrease in deaths (OS)
  • inconclusive 34 % decrease in progression or deaths (PFS) (PE)
versus pegylated liposomal doxorubicin and cyclophosphamide
atezolizumab based treatment
Alice, 2022
  NCT03164993		RCTla/mBC - TNBC - L2 - all populationatezolizumab and pegylated liposomal doxorubicin (PLD) and low-dose cyclophosphamideplacebo and pegylated liposomal doxorubicin (PLD) and low-dose cyclophosphamidepatients with mTNBC, 18 years of age or older, with no more than one prior line of chemotherapy in the metastatic setting. Inclusion of patients both with and without PD-L1 expression in tumors was allowed in this trial42 / 28high
 suggested
  • suggested 43 % decrease in progression or deaths (PFS) (PE)
The addition of atezolizumab to PLD/cyclophosphamide was tolerable with an indication of clinical benefit

la/mBC - TNBC - L2 - PDL1 positive breast cancer - triple negative breast cancer - triple negative metastatic mBC-Triple negative (TNBC) - 2nd Line (L2) la/mBC - TNBC - L2 - PDL1 positive

versus carboplatin, gemcitabine
atezolizumab based treatment
IMpassion-132 (PD-L1 positive population), 2024
  NCT03371017		RCTla/mBC - TNBC - L2 - 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 stage177 / 177low
 inconclusive
  • inconclusive 7 % decrease in deaths (OS) (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
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 or 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).
versus nab-paclitaxel, pegylated liposomal doxorubicin and cyclophosphamide
atezolizumab plus nab-paclitaxel
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 carboplatin, paclitaxel
atezolizumab plus carboplatin plus paclitaxel
NCI 10013, 2022
  NCT02883062		RCTes-BC - TNBC - NA - all populationatezolizumab carboplatine plus paclitaxelcarboplatine plus paclitaxelpatients with clinical stages II and III TNBC.PDL1 status unknown for 59% control and 22% traitement arm patients45 / 22high
 suggested
  • suggested 4.4-fold increase in pCR (PE)
versus paclitaxel followed by doxorubicin plus cyclophosphamide
atezolizumab plus paclitaxel
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.

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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