Table 1. Characteristics of eligible studies.
Study | First author country | Type of trail | Trial phase | Masking | Recruitment period | No. of center | Arms | TNBC definition | Clinical stage | No. of patients analyzed | Trial name/registry number |
Aft 2010 | America | Prospective RCT | II | Open-label | 2003–2006 | Single | 2 | ER/PR=0%, HER2= –; 1+; 2+/Hish– | II-III | 40 | NCT00242203 |
Houber 2010 | Switzerland | Prospective RCT | III | Open-label | 2002–2005 | Multiple | 4 | ER/PR<10%, HER2= –; 1+; 2+/Hish– | II-III | 89 | GeparTrio/NCT00544765 |
Bernsdorf 2011 | Sweden | Prospective RCT | II | Double-blind | 2004–2007 | Multiple | 2 | NA | II-III | 82 | NCT 00239343 |
Alba 2012 | Spain | Prospective RCT | II | Open-label | 2007–2010 | Multiple | 2 | ER/PR≤1%, HER2= –; 1+; 2+/Hish- | II-III | 93 | GEICAM/2006-03/NCT00432172 |
Gerber 2013 | Germany | Prospective RCT | III | Open-label | 2007–2010 | Multiple | 2 | ER/PR<10%, HER2= –; 1+; 2+/Hish– | II-III | 663 | GeparQuinto/GBG 44/NCT00567554 |
Ando 2014 | Japan | Prospective RCT | II | Open-label | 2010–2011 | Multiple | 2 | ER/PR<10%, HER2= –; 1+; 2+/Hish– | II-III | 75 | NA |
Earl 2014 | UK | Prospective RCT | III | Open-label | 2005–2007 | Multiple | 4 | ER/PR-NA; HER2= –; 1+; 2+/Hish– | II-III | 157 | Neo-tAnGo/ NCT00070278 |
Gonzalez-Angulo 2014 | America | Prospective RCT | II | Open-label | NA | Single | 2 | ER/PR≤5%; HER2= –; 1+; 2+/Hish- | II-III | 50 | NCT00499603 |
Steger 2014 | Austria | Prospective RCT | III | Open-label | 2004–2008 | Multiple | 2 | ER/PR<10%, HER2= –; 1+; 2+/Hish– | Non-IV | 127 | ABCSG-24/NCT00309556 |
von Minckwitz 2014 | Germany | Prospective RCT | II | Open-label | 2011–2012 | Multiple | 2 | ER/PR<1%, HER2= –; 1+; 2+/Hish– | II-III | 315 | GeparSixto-GBG 66/NCT01426880 |
Earl 2015 | UK | Prospective RCT | III | Open-label | 2009–2013 | Multiple | 2 | ER/PR score=0–2/8; HER2= –; 1+; 2+/Hish– | II-III | 241 | ARTemis/NCT01093235 |
Hasegawa 2015 | Japan | Prospective RCT | II | Open-label | 2010–2012 | Multiple | 2 | ER/PR-NA; HER2= –; 1+; 2+/Hish– | II-III | 34 | JONIE |
Llombart-Cussac 2015 | Spain | Prospective RCT | II | Open-label | 2010–2011 | Multiple | 3 | ER/PR<10%, HER2= –; 1+; 2+/Hish– | II-III | 140 | SOLTI NeoPARP/ NCT01204125 |
Martinez 2015 | Mexico | Prospective RCT | II | Open-label | NA | NA | 2 | NA | NA | 61 | NA |
Sikov 2015 | America | Prospective RCT | II | Open-label | 2009–2012 | Multiple | 4 | ER/PR≤10%, HER2= –; 1+; 2+/Hish– | II-III | 433 | CALGB 40603 |
Nahleh 2016 | America | Prospective RCT | II | Open-label | 2010–2012 | Multiple | 2 | ER/PR<1%, HER2= –; 1+; 2+/Hish– | II-III | 67 | SWOG S0800/ NCT00856492 |
Zhang 2016 | China | Prospective RCT | II | Open-label | 2006–2012 | NA | 2 | ER/PR<10%, HER2= –; 1+; 2+/Hish– | II-III | 87 | NCT01276769 |
Rugo 2016 | America | Prospective RCT | II | Open-label | 2010–2012 | Multiple | 2 | Special definition | II-III | 60 | I-SPY 2/NCT01042379 |
Enriquez 2017 | Peru | Prospective HCT | II | Open-label | 2013–2014 | Single | 2 | NA | II-III | 61 | NA? |
Gluz 2017 | Germany | Prospective RCT | II | Open-label | 2013–2015 | Multiple | 2 | ER/PR<1%, HER2= –; 1+; 2+/Hish– | Non-IV | 324 | WSG-ADAPT TN/NCT01815242 |
Jovanović 2017 | America | Prospective RCT | II | Double-blind | 2009–2013 | Multiple | 2 | ER/PR<10%, HER2= –; 1+; 2+/Hish– | II-III | 145 | NCT00242203 |
Loibl 2018 | Germany | Prospective RCT | III | Double-blind | 2014–2016 | Multiple | 3 | ER/PR<1%, HER2= –; 1+; 2+/Hish– | II-III | 634 | BrighTNess/NCT02032277 |
Wu 2018 | China | Prospective RCT | II | Open-label | 2014–2017 | Single | 2 | ER/PR<10%, HER2= –; 1+; 2+/Hish– | I-III | 121 | ChiCTR-TRC-14005019 |
RCT, randomized controlled trail; HCT, historical controlled trial; NA, not available.