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 Standard of Care (SoC)
capivasertib plus paclitaxel
PAKT (PIK3CA/AKT1/PTEN-altered), 2020
  NCT02423603		RCTmBC - Triple negative (TNBC) - 1st Line (L1)capiversatib plus paclitaxelplacebo plus paclitaxelPatients had histologically confirmed, metastatic or locally advanced TNBC not amenable to curative resection. Previous systemic therapy for locally advanced or metastatic disease was not permitted, but previous adjuvant or neoadjuvant chemotherapy was allowed.17 / 11NA
 suggested
  • suggested 70 % decrease in progression or deaths (PFS)

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 plus placebo
nab-paclitaxel plus toripalimab
TORCHLIGHT, 2024
  NCT04085276		RCTla/mBC - TNBC - L1 - all populationtoripalimab 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)
versus placebo plus 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 placebo plus 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 / 220NA
 inconclusive
  • inconclusive 14 % decrease in progression or deaths (PFS),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
versus placebo plus SoC
pembrolizumab plus SoC
KEYNOTE-355 (all population), 2020
  NCT02819518		RCTla/mBC - 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)
capivasertib plus paclitaxel
PAKT (all population), 2020
  NCT02423603		RCTla/mBC - TNBC - L1 - all populationcapiversatib plus paclitaxelplacebo plus paclitaxelPatients had histologically confirmed, metastatic or locally advanced TNBC not amenable to curative resection. Previous systemic therapy for locally advanced or metastatic disease was not permitted, but previous adjuvant or neoadjuvant chemotherapy was allowed.70 / 70NA
 suggested
  • suggested 39 % decrease in deaths (OS)
  • inconclusive 26 % decrease in progression or deaths (PFS) (PE)
ipatasertib plus paclitaxel
LOTUS, 2017
  NCT02162719		RCTla/mBC - TNBC - L1 - all populationipatasertib plus paclitaxelplacebo plus paclitaxelWomen with locally advanced or metastatic TNBC not amenable to curative resection. Previous systemic therapy for locally advanced or metastatic disease was not permitted. Previous (neo)adjuvant treatment completed at least 6 months before the first dose was allowed62 / 62NA
 suggested
  • suggested 40 % decrease in progression or deaths (PFS) (PE)
veliparib plus paclitaxel plus carboplatin
BrighTNess (velaparib-P-C (arm A) vs paclitaxel - carboplatin (arm B)), 2018
  NCT02032277		RCTla/mBC - TNBC - L1 - all populationveliparib plus paclitaxel plus carboplatinplacebo plus paclitaxel plus carboplatinPatients: women who had histologically or cytologically confirmed invasive TNBC, clinical stage II-III316 / 160NA
 inconclusive
  • inconclusive 12 % increase in events or deaths (EFS) (PE)
  • inconclusive 25 % increase in events or deaths (EFS) (PE)
  • inconclusive 16 % decrease in pCR (PE)
BrighTNess (velaparib-P-C (arm A) vs paclitaxel alone (arm C)), 2018
  NCT02032277		RCTla/mBC - TNBC - L1 - all populationveliparib plus paclitaxel plus carboplatinplacebo matching veliparib plus placebo matching carboplatin plus paclitaxelPatients: women who had histologically or cytologically confirmed invasive TNBC, clinical stage II-III316 / 158NA
 conclusif
  • inconclusive 18 % decrease in deaths (OS) (PE)
  • demonstrated 1.5-fold increase in pCR (PE)
  • suggested 37 % decrease in events or deaths (EFS) (PE)

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 plus placebo
nab-paclitaxel plus toripalimab
TORCHLIGHT PDL 1 positive population, 2024
  NCT04085276		RCTla/mBC - TNBC - L1 - PDL1 positivetoripalimab 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 surgery200 / 100low
 conclusif
  • suggested 38 % decrease in deaths (OS)
  • demonstrated 35 % decrease in progression or deaths (PFS) (PE)
The addition of toripalimab to nab-P provided a significant improvement in PFS for PD-L1-positive patients with metastatic or recurrent TNBC with an acceptable safety profile.
versus placebo plus 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 placebo plus SoC
pembrolizumab plus SoC
KEYNOTE-355 (CPS>1), 2020
  NCT02819518		RCTla/mBC - 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		RCTla/mBC - 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 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 / 101NA
 inconclusive
  • inconclusive 18 % decrease in progression or deaths (PFS),progression or deaths (PFS) (PE)

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

versus Standard of Care (SoC)
sacituzumab govitecan
ASCENT (all population), 2021
  NCT02574455		RCTmBC-Triple negative (TNBC) - 2nd Line (L2)Sacituzumab govitecansingle agent chemotheraopy of the physician's choice (eribulin, vinorelbine, capecitabine or gemcitabine)Patients with metastatic triple-negative breast cancer that was relapsed or refractory to two or more previous standard chemotherapy regimens for unresectable, locally andvanced or metastatic disease (previous thearapy had to include taxanes).267 / 262NA
 suggested
  • suggested 49 % decrease in deaths (OS) (PE)
  • suggested 57 % decrease in progression or deaths (PFS) (PE)
ASCENT (patients without brain metastases), 2021
  NCT02574455		RCTmBC-Triple negative (TNBC) - 2nd Line (L2)Sacituzumab govitecansingle agent chemotheraopy² of the physician's choice (eribulin, vinorelbine, capecitabine or gemcitabine)Patients with metastatic triple-negative breast cancer that was relapsed or refractory to two or more previous standard chemotherapy regimens for unresectable, locally andvanced or metastatic disease (previous thearapy had to include taxanes).235 / 233NA
 suggested
  • suggested 52 % decrease in deaths (OS) (PE)
  • suggested 59 % decrease in progression or deaths (PFS) (PE)
talazoparib
EMBRACA, 2018
  NCT01945775		RCTmBC-Triple negative (TNBC) - 2nd Line (L2)talazoparibchemotherapyPatients with HER2-negative locally advanced or metastatic breast cancer and a deleterious or suspected deleterious gBRCA1/2 mutation. Patients had received 3 or less previous cytotoxic regimens for advanced disease and previous treatment with a taxane, an anthracycline, or both (unless contraindicated).287 / 144NA
 conclusif
  • inconclusive 15 % decrease in deaths (OS) (PE)
  • demonstrated 46 % decrease in progression or deaths (PFS) (PE)
  • demonstrated 4.0-fold increase in objective responses (ORR) (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 placebo plus SoC
atezolizumab plus SoC
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 Standard of Care (SoC)
olaparib
OlympiAD, 2017
  NCT02000622		RCTla/mBC - TNBC - L2 - all populationolaparibstandard chemotherapyPatients with HER-2 negative metastatic breast cancer that was HR positive or triple negative. Patients had a confirmed deleterious or suspected deleterious germline BRCA mutation and had receive no more than 2 previous chemotherapy regimens for metastatic disease.205 / 97NA
 conclusif
  • inconclusive 10 % decrease in deaths (OS) (PE)
  • demonstrated 42 % decrease in progression or deaths (PFS) (PE)
pembrolizumab alone
KEYNOTE-119 (all population), 2019

          NCT02555657    		RCTla/mBC - 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),deaths (OS) (PE)
    • statistically significant 60 % increase in progression or deaths (PFS),progression or deaths (PFS)
    • statistically significant 40 % decrease in DCR,DCR

    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 placebo plus SoC
    atezolizumab plus SoC
    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)
    versus Standard of Care (SoC)
    pembrolizumab alone
    KEYNOTE-119 PD-L1 positive (CPS = 10 or more), 2019

              NCT02555657      		RCTla/mBC - TNBC - L2 - PDL1 positivePembrolizumabchemotherapy (single agent)patients with previously treated metastatic triple negative breast cancer (mTNBC)96 / 98some concern
      		 inconclusive
      • inconclusive 22 % decrease in deaths (OS),deaths (OS) (PE)
      KEYNOTE-119 PD-L1 positive (CPS = 1 or more), 2019

                  NCT02555657        		RCTla/mBC - TNBC - L2 - PDL1 positivePembrolizumabchemotherapy (single agent)patients with previously treated metastatic triple negative breast cancer (mTNBC)203 / 202some concern
        		 inconclusive
        • inconclusive 14 % decrease in deaths (OS),deaths (OS) (PE)
        • statistically significant 35 % increase in progression or deaths (PFS),progression or deaths (PFS)
        KEYNOTE-119 (PDL1 CPS>10), 2019

                      NCT02555657          		RCTla/mBC - 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),deaths (OS) (PE)
          KEYNOTE-119 (PDL1 CPS>1), 2019

                          NCT02555657            		RCTla/mBC - 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),deaths (OS) (PE)
            • statistically significant 35 % increase in progression or deaths (PFS),progression or deaths (PFS)

            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)
            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.
            A-Brave Stratum A, 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
            		 inconclusive
            • inconclusive 19 % decrease in RFS/DFS (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 placebo
            olaparib
            OlympiA (BIG 6-13, NSABP B-55) unpublished
              NCT02032823            		RCTes-BC - TNBC - NA - all populationolaparibplacebopatients with human epidermal growth factor receptor 2 (HER2)–negative early breast cancer with BRCA1 or BRCA2 germline pathogenic or likely pathogenic variants and high-risk clinicopathological factors921 / 915NA
            		 conclusif
            • demonstrated 32 % decrease in deaths (OS) (PE)
            • demonstrated 42 % decrease in iDFS (PE)
            pembrolizumab alone
            KEYNOTE-522, 2020
              NCT03036488            		RCTes-BC - TNBC - NA - all populationpembrolizumab plus SOCplacebo plus SOCpreviously previously untreated, nonmetastatic disease, stage II or stage III, triple-negative breast cancer centrally confirmed784 / 390low
            		 conclusif
            • demonstrated 37 % decrease in events or deaths (EFS) (extended) (PE)
            • demonstrated 12.6-fold increase in pCR (PE)
            • suggested 37 % decrease in events or deaths (EFS) (PE)
            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).

            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)

             

            - About us - Contact us - Method - RSS Made with in Lyon - Credits - Privacy policy - Licence Creative Commons