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
toripalimab
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)

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 placebo plus SoC
pembrolizumab plus SoC
KEYNOTE-355 (all population), 2020
  NCT02819518		RCTmBC - TNBC - L1 - all populationPembrolizumab plus chemotherapyplacebo plus chemotherapypatients with with untreated locally recurrent inoperable or metastatic triple-negative breast cancer (all population)566 / 281low
 inconclusive
  • inconclusive 11 % decrease in deaths (OS) (PE)
  • suggested 18 % decrease in progression or deaths (PFS) (PE)
  • statistically significant 76 % decrease in objective responses (ORR)
OS results from ESMO Congres 2021
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
pembrolizumab plus SoC
KEYNOTE-355 (CPS>1), 2020
  NCT02819518		RCTmBC - TNBC - L1 - PDL1 positivePembrolizumab plus chemotherapyplacebo plus chemotherapypatients with with untreated locally recurrent inoperable or metastatic triple-negative breast cancer (PDL1 CPS>1)425 / 211low
 suggested
  • inconclusive 14 % decrease in deaths (OS) (PE)
  • suggested 25 % decrease in progression or deaths (PFS) (PE)
OS results from ESMO Congres 2021
KEYNOTE-355 (CPS>10), 2020
  NCT02819518		RCTmBC - TNBC - L1 - PDL1 positivePembrolizumab plus chemotherapyplacebo plus chemotherapypatients with with untreated locally recurrent inoperable or metastatic triple-negative breast cancer (PDL1 CPS>10)220 / 103low
 conclusif
  • demonstrated 27 % decrease in deaths (OS) (PE)
  • demonstrated 34 % decrease in progression or deaths (PFS) (PE)
OS results from ESMO Congres 2021
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)

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

versus Standard of Care (SoC)
pembrolizumab alone
KEYNOTE-119 (all population), 2019
  NCT02555657		RCTmBC - 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

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

versus Standard of Care (SoC)
pembrolizumab alone
KEYNOTE-119 (PDL1 CPS>1), 2019
  NCT02555657		RCTmBC - TNBC - L2 - PDL1 positivePembrolizumabchemotherapy (single agent)patients with previously treated metastatic triple negative breast cancer (mTNBC) patients with PDL1 CPS> 1 only203 / 202some concern
 inconclusive
  • inconclusive 14 % decrease in deaths (OS) (PE)
  • statistically significant 35 % increase in progression or deaths (PFS)
KEYNOTE-119 (PDL1 CPS>10), 2019
  NCT02555657		RCTmBC - TNBC - L2 - PDL1 positivePembrolizumabchemotherapy (single agent)patients with previously treated metastatic triple negative breast cancer (mTNBC) patients with PDL1 CPS> 10 only96 / 98some concern
 inconclusive
  • inconclusive 22 % decrease in deaths (OS) (PE)

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

versus non active control
avelumab alone
A-Brave, 2024
  NCT02926196		RCTes-BC - Triple negatif (TNBC) - (neo)adjuvant (NA)avelumabcontrolPatiennts at High-risk Triple Negative Breast Cancer after completion of standard treatment with curative intent including surgery and neoadjuvant/adjuvant chemotherapy.-/-NA
 suggested
  • suggested 34 % decrease in deaths (OS)
  • inconclusive 18 % decrease in RFS/DFS (PE)
  • inconclusive 19 % decrease in RFS/DFS (PE)
One year adjuvant avelumab versus control does not significantly improve DFS in high-risk TNBC patients. Nevertheless, the secondary enpoind OS was significanlty improved with avelumab vs control.

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
durvalumab alone
GeparNuevo, 2019
  NCT02685059		RCTes-BC - TNBC - NA - all populationdurvalumab followed by nab-paclitaxelplacebo followed by nab-paclitaxelPatients with previously untreated uni- or bilateral primary, non-metastatic invasive TNBC with a tumour of at least 2 cm (cT2-cT4a-d) treated as neoadjuvant88 / 86some concern
 suggested
  • suggested 76 % decrease in deaths (OS) (extension)
  • inconclusive 45 % increase in pCR (PE)
pembrolizumab alone
KEYNOTE-522, 2020
  NCT03036488		RCTes-BC - TNBC - NA - all populationpembrolizumabplacebopreviously previously untreated, nonmetastatic disease, stage II or stage III, triple-negative breast cancer treated with paclitaxel and carboplatin, treated for neoadjuvant phase and an adjuvant phase;784 / 390low
 conclusif
  • demonstrated 12.6-fold increase in pCR (PE)
  • suggested 37 % decrease in events or deaths (EFS) (PE)
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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