Study study type PathologyT1T0Patientssample sizesROB Results

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

mBC - TNBC - L1 - all population breast cancer - triple negative 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),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
capivasertib plus paclitaxel
PAKT (all population), 2020
  NCT02423603
RCTmBC - 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
RCTmBC - 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
RCTmBC - 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
RCTmBC - 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)

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

versus placebo plus SoC
pembrolizumab plus SoC
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
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
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),progression or deaths (PFS) (PE)