Table 1 Main characteristics of the included clinical studies
Study ID | Auther-year | Journal | Masking | RCT | Arms | Medicine | Clinical stage | TNBC definition | Endpoints | Total numbers | pCR (%) | HR for DFS | P value | HR for OS | P value |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
NATT trial | Xiaosong Chen-2013 | Breast Cancer Res Treat | Open-label | RCT | 2 | TAC vs TC | IIB—IIIC | ER < 1% PR < 1% Her2(0–2 + FISH-) | pCR EFS DFS OS | 26 | 15.40% | DFS 0.33(0.12–0.95) | 0.004 | 0.52(0.06–0.46) | 0.045 |
23 | 4.30% | ||||||||||||||
PREPARE trial(NCT00544232) | M. Untch-2011 | Annals of Oncology | Open-label | RCT | 2 | ddE-ddT-CMF vs EC-T | IIB—IIIC | ER < 1% PR < 1% Her2(0–2 + FISH-) | pCR EFS DFS OS | 363 | 18.70% | 1.14(0.85–1.52) | 0.37 | 1.26(0.86–1.85) | 0.237 |
370 | 13.20% | ||||||||||||||
NeoSTOP(NCT02413320) | Priyanka Sharma-2021 | Clin Cancer Res | Open-label | RCT | 2 | CbP-AC vs CbD | I—III | ER < 10% PR < 10% Her2(-) | pCR EFS OS | 48 | 54.00% | EFS → DFS 2.85(0.34–23.60) |  > 0.05 | 1.83(0.28–11.76) |  > 0.05 |
52 | 54.00% | ||||||||||||||
NeoCART (NCT03154749) | Liulu Zhang-2021 | Int J Cancer | Open-label | RCT | 2 | DCb vs EC-D | II-III | ER < 1% PR < 1% Her2(0–2 + FISH-) | pCR EFS OS | 44 | 61.40% | EFS → DFS 0.76(0.2–2.84) | 0.683 | 0.96(0.19–4.76) | 0.959 |
44 | 38.60% | ||||||||||||||
(UMIN000003355) | Madoka Iwase-2020 | Breast Cancer Research and Treatment | Open-label | RCT | 2 | CbP-CEF vs P-CEF | II-III | ER(-) PR(-) Her2(0–2 + FISH-) | DFS OS pCR | 37 | 61.20% | 0.22(0.06–0.82) | 0.015 | 0.12(0.01–0.96) | 0.046 |
38 | 26.30% | ||||||||||||||
GeparOcto (NCT02125344) | Andreas Schneeweiss-2022 | European Journal of Cancer | Open-label | RCT | 2 | PMCb vs iddEPC | II | ER(-) PR(-) Her2(0–2 + FISH-) | pCR iDFS OS | 203 | 48.00% | 0.73(0.47–1.13) | 0.1562 | 0.66(0.38–1.15) | 0.1442 |
200 | 48.30% | ||||||||||||||
WSG-ADAPT-TN (NCT01815242) | Oleg Gluz-2022 | European Journal of Cancer | Open-label | RCT | 2 | nab-pac + Cb vs nab-pac + G | I-III | ER < 1% PR < 1% Her2(0–2 + FISH-) | pCR i/dDFS OS | 182 | 44.00% | 1.21(0.76–1.94) | 0.424 | 1.06(0.63–1.78) | 0.836 |
154 | 28.00% | ||||||||||||||
GeparSixto (NCT01426880) | Eric Hahnen-2017 | JAMA Oncol | Open-label | RCT | 2 | PMBevCb vs PMBev | II-III | ER < 1% PR < 1% Her2(0–2 + FISH-) | pCR DFS | 158 | 53.20% | 0.53(0.29–0.96) | 0.04 | NA |  |
157 | 36.90% | ||||||||||||||
(NCT01276769) | Pin Zhang-2016 | Oncotarget | Open-label | RCT | 2 | pac + Cb vs pacE | II-III | ER < 10% PR < 10% Her2(0–2 + FISH-) | pCR RFS OS | 47 | 38.60% | (RFS → DFS) 0.35(0.13–0.96) | 0.043 | 1.20(0.37–3.87) | 0.350 |
44 | 14.00% | ||||||||||||||
CALGB 40603 (NCT00861705) | William M.Sikov-2022 | J Clin Oncol | Open-label | RCT | 2 | pac + Cb + AC vs pac + AC | II-III | ER < 10% PR < 10% Her2(-) | pCR EFS OS | 221 | 54% | (EFS → DFS) 0.94(0.67–1.32) | 0.7210 | OS 1.12(0.77–1.61) | 0.5585 |
212 | 41% | ||||||||||||||
(ChiCTR-TRC-14005019) | Wenting Yan-2022 | Ther Adv Med Oncol | Open-label | RCT | 2 | TEL vs TE | I-III | ER < 10% PR < 10% Her2(0–2 + FISH-) | tpCR DFS OS | 99 | 41.40% | 0.44(0.21–0.90) | 0.028 | 0.44(0.18–1.02) | 0.061 |
101 | 17.80% | ||||||||||||||
Kun Wang (SABCS) | Kun Wang-2022 | SABCS | Open-label | RCT | 2 | wPCb-AC vs wP-AC | II | NA | DFS OS pCR | 365 | 55.20% | 0.79(0.61–1.02) | 0.073 | 0.75(0.57–0.98) | 0.034 |
355 | 41.50% | ||||||||||||||
I-SPY2 Trial(NCT01042379) | Nanda, R-2020 | JAMA Oncol | Open-label | RCT | 2 | P + pac + AC vs PBO + pac + AC | II-III | ER(-) PR(-) Her2(-) | pCR EFS | 29 | 60.00% | EFS → DFS 0.6(0.36–3.81) |  > 0.05 | NA | NA |
85 | 22.00% | ||||||||||||||
168 | 41.1% | ||||||||||||||
KEYNOTE-173 (NCT02622074) | P. Schmid-2020 | Annals of Oncology | Open-label | RCT | 6 | P + Nab-pac + AC vs P + Nab-pac + Cb + AC vs P + Nab-pac + Cb + AC vs P + Nab-pac + Cb + AC vs P + pac + Cb + AC vs P + pac + Cb + AC | II-III | ER < 1% PR < 1% Her2(0–2 + FISH-) | pCR EFS OS | 10 | 60% | EFS → DFS NA | NA | NA | NA |
10 | 80% | ||||||||||||||
10 | 80% | ||||||||||||||
10 | 60% | ||||||||||||||
10 | 30% | ||||||||||||||
10 | 50% | ||||||||||||||
KEYNOTE-522(NCT03036488) | P. Schmid-2020 | New England Journal of Medicine | Open-label | RCT | 2 | P + pac + Cb + A/EC vs pbo + pac + Cb + A/EC | II-III | ER(-) PR(-) Her2(0–2 + FISH-) | pCR EFS | 784 | 64.80% | EFS → DFS 0.63(0.48–0.82) | P < 0.001 | NA |  |
390 | 51.20% | ||||||||||||||
GeparNuevo (NCT02685059) | S. Loibl-2022 | Annals of Oncology | Open-label | RCT | 2 | Dur + nab-pac vs PBO + nab-pac | I-III | NA | pCR iDFS DDFS OS | 88 | NA | DDFS → DFS 0.31(0.13–0.74) | 0.005 | 0.24(0.08–0.72) | 0.006 |
86 | NA | ||||||||||||||
BrighTNess (NCT02032277) | Sibylle Loibl-2022 | Annals of Oncology | Open-label | RCT | 3 | Paclitaxel + carboplatin + veliparib vs Paclitaxel + carboplatin + veliparib placebo vs Paclitaxel + carboplatin placebo  + veliparib placebo | I-III | ER < 1% PR < 1% Her2(0 or 1 +) | pCR EFS OS breast-conservation surgery | 316 | 53.00% | EFS → DFS 1.12(0.72–1.72) (1 vs 2) 0.56(0.34–0.93) (2 vs 3) | 0.62(1 vs 2) 0.02(2 vs 3) | 1.25 (0.70–2.24) (1 vs 2) 0.63 (0.33–1.21) (2 vs 3) | 0.46 (1 vs 2) 0.17 (2 vs 3) |
160 | 58.00% | ||||||||||||||
158 | 31.00% | ||||||||||||||
NSABP-B40(NCT00408408) | Harry D Bear-2015 | Lancet Oncol | Open-label | RCT | 2 | Bev +  vs Non-Bev | I-III | ER(-) PR(-) Her2(-) | pCR EFS | 592 | 51.10% | 0.8 (0.63–1.01) | 0.06 | 0.65(0.49–0.88) | 0.004 |
594 | 47.10% | ||||||||||||||
GeparQuinto(NCT00567554) | G. von Minckwitz-2014 | Annals of Oncology | Open-label | RCT | 2 | ECB-DB vs EC-D | II-III | ER (< 10%) PR (< 10%) Her2(0–2 + FISH-) | pCR DFS OS | 323 | 39.30% | 1.03(0.84–1.25) | 0.784 | 0.97(0.75–1.26) | 0.842 |
340 | 27.90% | ||||||||||||||
SWOG S0800(NCT00856492) | Z. A. Nahleh-2016 | Breast Cancer Res Treat | Open-label | RCT | 2 | Bev + nab-pac + ddAC vs Non-Bev-based | IIB—IIIC | ER(-) PR(-) Her2(-) | pCR DFS OS | 98 | 59.40% | EFS → DFS 0.46(0.2–1.05) | 0.06 | 0.49(0.19–1.29) | 0.14 |
113 | 28.60% | ||||||||||||||
ARTemis(NCT01093235) | H. M. Earl-2017 | Annals of Oncology | Open-label | RCT | 2 | Bev + D-FEC vs D-FEC | NA | (ER) status as negative when Allred score was 0–2/8; ER weakly positive was 3–5/8; and ER strongly positive was 6–8/8 Her2(0–2 + FISH-) | pCR DFS OS | 388 | 22.00% | 1.18(0.89–1.57) | 0.25 | 1.26(0.9–1.76) | 0.19 |
393 | 17.00% | ||||||||||||||
Study ID | Auther-year | Journal | Masking | RCT | Arms | Medicine | Clinical stage | TNBC definition | Endpoints | Total numbers | pCR (%) | HR for DFS | P value | HR for OS | P value |
NATT trial | Xiaosong Chen-2013 | Breast Cancer Res Treat | Open-label | RCT | 2 | TAC vs TC | IIB—IIIC | ER < 1% PR < 1% Her2(0–2 + FISH-) | pCR EFS DFS OS | 26 | 15.40% | DFS 0.33(0.12–0.95) | 0.004 | 0.52(0.06–0.46) | 0.045 |
23 | 4.30% | ||||||||||||||
PREPARE trial(NCT00544232) | M. Untch-2011 | Annals of Oncology | Open-label | RCT | 2 | ddE-ddT-CMF vs EC-T | IIB—IIIC | ER < 1% PR < 1% Her2(0–2 + FISH-) | pCR EFS DFS OS | 363 | 18.70% | 1.14(0.85–1.52) | 0.37 | 1.26(0.86–1.85) | 0.237 |
370 | 13.20% | ||||||||||||||
NeoSTOP(NCT02413320) | Priyanka Sharma-2021 | Clin Cancer Res | Open-label | RCT | 2 | CbP-AC vs CbD | I—III | ER < 10% PR < 10% Her2(-) | pCR EFS OS | 48 | 54.00% | EFS → DFS 2.85(0.34–23.60) |  > 0.05 | 1.83(0.28–11.76) |  > 0.05 |
52 | 54.00% | ||||||||||||||
NeoCART (NCT03154749) | Liulu Zhang-2021 | Int J Cancer | Open-label | RCT | 2 | DCb vs EC-D | II-III | ER < 1% PR < 1% Her2(0–2 + FISH-) | pCR EFS OS | 44 | 61.40% | EFS → DFS 0.76(0.2–2.84) | 0.683 | 0.96(0.19–4.76) | 0.959 |
44 | 38.60% | ||||||||||||||
(UMIN000003355) | Madoka Iwase-2020 | Breast Cancer Research and Treatment | Open-label | RCT | 2 | CbP-CEF vs P-CEF | II-III | ER(-) PR(-) Her2(0–2 + FISH-) | DFS OS pCR | 37 | 61.20% | 0.22(0.06–0.82) | 0.015 | 0.12(0.01–0.96) | 0.046 |
38 | 26.30% | ||||||||||||||
GeparOcto (NCT02125344) | Andreas Schneeweiss-2022 | European Journal of Cancer | Open-label | RCT | 2 | PMCb vs iddEPC | II | ER(-) PR(-) Her2(0–2 + FISH-) | pCR iDFS OS | 203 | 48.00% | 0.73(0.47–1.13) | 0.1562 | 0.66(0.38–1.15) | 0.1442 |
200 | 48.30% | ||||||||||||||
WSG-ADAPT-TN (NCT01815242) | Oleg Gluz-2022 | European Journal of Cancer | Open-label | RCT | 2 | nab-pac + Cb vs nab-pac + G | I-III | ER < 1% PR < 1% Her2(0–2 + FISH-) | pCR i/dDFS OS | 182 | 44.00% | 1.21(0.76–1.94) | 0.424 | 1.06(0.63–1.78) | 0.836 |
154 | 28.00% | ||||||||||||||
GeparSixto (NCT01426880) | Eric Hahnen-2017 | JAMA Oncol | Open-label | RCT | 2 | PMBevCb vs PMBev | II-III | ER < 1% PR < 1% Her2(0–2 + FISH-) | pCR DFS | 158 | 53.20% | 0.53(0.29–0.96) | 0.04 | NA |  |
157 | 36.90% | ||||||||||||||
(NCT01276769) | Pin Zhang-2016 | Oncotarget | Open-label | RCT | 2 | pac + Cb vs pacE | II-III | ER < 10% PR < 10% Her2(0–2 + FISH-) | pCR RFS OS | 47 | 38.60% | (RFS → DFS) 0.35(0.13–0.96) | 0.043 | 1.20(0.37–3.87) | 0.350 |
44 | 14.00% | ||||||||||||||
CALGB 40603 (NCT00861705) | William M.Sikov-2022 | J Clin Oncol | Open-label | RCT | 2 | pac + Cb + AC vs pac + AC | II-III | ER < 10% PR < 10% Her2(-) | pCR EFS OS | 221 | 54% | (EFS → DFS) 0.94(0.67–1.32) | 0.7210 | OS 1.12(0.77–1.61) | 0.5585 |
212 | 41% | ||||||||||||||
(ChiCTR-TRC-14005019) | Wenting Yan-2022 | Ther Adv Med Oncol | Open-label | RCT | 2 | TEL vs TE | I-III | ER < 10% PR < 10% Her2(0–2 + FISH-) | tpCR DFS OS | 99 | 41.40% | 0.44(0.21–0.90) | 0.028 | 0.44(0.18–1.02) | 0.061 |
101 | 17.80% | ||||||||||||||
Kun Wang (SABCS) | Kun Wang-2022 | SABCS | Open-label | RCT | 2 | wPCb-AC vs wP-AC | II | NA | DFS OS pCR | 365 | 55.20% | 0.79(0.61–1.02) | 0.073 | 0.75(0.57–0.98) | 0.034 |
355 | 41.50% | ||||||||||||||
I-SPY2 Trial(NCT01042379) | Nanda, R-2020 | JAMA Oncol | Open-label | RCT | 2 | P + pac + AC vs PBO + pac + AC | II-III | ER(-) PR(-) Her2(-) | pCR EFS | 29 | 60.00% | EFS → DFS 0.6(0.36–3.81) |  > 0.05 | NA | NA |
85 | 22.00% | ||||||||||||||
168 | 41.1% | ||||||||||||||
KEYNOTE-173 (NCT02622074) | P. Schmid-2020 | Annals of Oncology | Open-label | RCT | 6 | P + Nab-pac + AC vs P + Nab-pac + Cb + AC vs P + Nab-pac + Cb + AC vs P + Nab-pac + Cb + AC vs P + pac + Cb + AC vs P + pac + Cb + AC | II-III | ER < 1% PR < 1% Her2(0–2 + FISH-) | pCR EFS OS | 10 | 60% | EFS → DFS NA | NA | NA | NA |
10 | 80% | ||||||||||||||
10 | 80% | ||||||||||||||
10 | 60% | ||||||||||||||
10 | 30% | ||||||||||||||
10 | 50% | ||||||||||||||
KEYNOTE-522(NCT03036488) | P. Schmid-2020 | New England Journal of Medicine | Open-label | RCT | 2 | P + pac + Cb + A/EC vs pbo + pac + Cb + A/EC | II-III | ER(-) PR(-) Her2(0–2 + FISH-) | pCR EFS | 784 | 64.80% | EFS → DFS 0.63(0.48–0.82) | P < 0.001 | NA |  |
390 | 51.20% | ||||||||||||||
GeparNuevo (NCT02685059) | S. Loibl-2022 | Annals of Oncology | Open-label | RCT | 2 | Dur + nab-pac vs PBO + nab-pac | I-III | NA | pCR iDFS DDFS OS | 88 | NA | DDFS → DFS 0.31(0.13–0.74) | 0.005 | 0.24(0.08–0.72) | 0.006 |
86 | NA | ||||||||||||||
BrighTNess (NCT02032277) | Sibylle Loibl-2022 | Annals of Oncology | Open-label | RCT | 3 | Paclitaxel + carboplatin + veliparib vs Paclitaxel + carboplatin + veliparib placebo vs Paclitaxel + carboplatin placebo  + veliparib placebo | I-III | ER < 1% PR < 1% Her2(0 or 1 +) | pCR EFS OS breast-conservation surgery | 316 | 53.00% | EFS → DFS 1.12(0.72–1.72) (1 vs 2) 0.56(0.34–0.93) (2 vs 3) | 0.62(1 vs 2) 0.02(2 vs 3) | 1.25 (0.70–2.24) (1 vs 2) 0.63 (0.33–1.21) (2 vs 3) | 0.46 (1 vs 2) 0.17 (2 vs 3) |
160 | 58.00% | ||||||||||||||
158 | 31.00% | ||||||||||||||
NSABP-B40(NCT00408408) | Harry D Bear-2015 | Lancet Oncol | Open-label | RCT | 2 | Bev +  vs Non-Bev | I-III | ER(-) PR(-) Her2(-) | pCR EFS | 592 | 51.10% | 0.8 (0.63–1.01) | 0.06 | 0.65(0.49–0.88) | 0.004 |
594 | 47.10% | ||||||||||||||
GeparQuinto(NCT00567554) | G. von Minckwitz-2014 | Annals of Oncology | Open-label | RCT | 2 | ECB-DB vs EC-D | II-III | ER (< 10%) PR (< 10%) Her2(0–2 + FISH-) | pCR DFS OS | 323 | 39.30% | 1.03(0.84–1.25) | 0.784 | 0.97(0.75–1.26) | 0.842 |
340 | 27.90% | ||||||||||||||
SWOG S0800(NCT00856492) | Z. A. Nahleh-2016 | Breast Cancer Res Treat | Open-label | RCT | 2 | Bev + nab-pac + ddAC vs Non-Bev-based | IIB—IIIC | ER(-) PR(-) Her2(-) | pCR DFS OS | 98 | 59.40% | EFS → DFS 0.46(0.2–1.05) | 0.06 | 0.49(0.19–1.29) | 0.14 |
113 | 28.60% | ||||||||||||||
ARTemis(NCT01093235) | H. M. Earl-2017 | Annals of Oncology | Open-label | RCT | 2 | Bev + D-FEC vs D-FEC | NA | (ER) status as negative when Allred score was 0–2/8; ER weakly positive was 3–5/8; and ER strongly positive was 6–8/8 Her2(0–2 + FISH-) | pCR DFS OS | 388 | 22.00% | 1.18(0.89–1.57) | 0.25 | 1.26(0.9–1.76) | 0.19 |
393 | 17.00% | ||||||||||||||
Study ID | Auther-year | Journal | Masking | RCT | Arms | Medicine | Clinical stage | TNBC definition | Endpoints | Total numbers | pCR (%) | HR for DFS | P value | HR for OS | P value |
NATT trial | Xiaosong Chen-2013 | Breast Cancer Res Treat | Open-label | RCT | 2 | TAC vs TC | IIB—IIIC | ER < 1% PR < 1% Her2(0–2 + FISH-) | pCR EFS DFS OS | 26 | 15.40% | DFS 0.33(0.12–0.95) | 0.004 | 0.52(0.06–0.46) | 0.045 |
23 | 4.30% | ||||||||||||||
PREPARE trial(NCT00544232) | M. Untch-2011 | Annals of Oncology | Open-label | RCT | 2 | ddE-ddT-CMF vs EC-T | IIB—IIIC | ER < 1% PR < 1% Her2(0–2 + FISH-) | pCR EFS DFS OS | 363 | 18.70% | 1.14(0.85–1.52) | 0.37 | 1.26(0.86–1.85) | 0.237 |
370 | 13.20% | ||||||||||||||
NeoSTOP(NCT02413320) | Priyanka Sharma-2021 | Clin Cancer Res | Open-label | RCT | 2 | CbP-AC vs CbD | I—III | ER < 10% PR < 10% Her2(-) | pCR EFS OS | 48 | 54.00% | EFS → DFS 2.85(0.34–23.60) |  > 0.05 | 1.83(0.28–11.76) |  > 0.05 |
52 | 54.00% | ||||||||||||||
NeoCART (NCT03154749) | Liulu Zhang-2021 | Int J Cancer | Open-label | RCT | 2 | DCb vs EC-D | II-III | ER < 1% PR < 1% Her2(0–2 + FISH-) | pCR EFS OS | 44 | 61.40% | EFS → DFS 0.76(0.2–2.84) | 0.683 | 0.96(0.19–4.76) | 0.959 |
44 | 38.60% | ||||||||||||||
(UMIN000003355) | Madoka Iwase-2020 | Breast Cancer Research and Treatment | Open-label | RCT | 2 | CbP-CEF vs P-CEF | II-III | ER(-) PR(-) Her2(0–2 + FISH-) | DFS OS pCR | 37 | 61.20% | 0.22(0.06–0.82) | 0.015 | 0.12(0.01–0.96) | 0.046 |
38 | 26.30% | ||||||||||||||
GeparOcto (NCT02125344) | Andreas Schneeweiss-2022 | European Journal of Cancer | Open-label | RCT | 2 | PMCb vs iddEPC | II | ER(-) PR(-) Her2(0–2 + FISH-) | pCR iDFS OS | 203 | 48.00% | 0.73(0.47–1.13) | 0.1562 | 0.66(0.38–1.15) | 0.1442 |
200 | 48.30% | ||||||||||||||
WSG-ADAPT-TN (NCT01815242) | Oleg Gluz-2022 | European Journal of Cancer | Open-label | RCT | 2 | nab-pac + Cb vs nab-pac + G | I-III | ER < 1% PR < 1% Her2(0–2 + FISH-) | pCR i/dDFS OS | 182 | 44.00% | 1.21(0.76–1.94) | 0.424 | 1.06(0.63–1.78) | 0.836 |
154 | 28.00% | ||||||||||||||
GeparSixto (NCT01426880) | Eric Hahnen-2017 | JAMA Oncol | Open-label | RCT | 2 | PMBevCb vs PMBev | II-III | ER < 1% PR < 1% Her2(0–2 + FISH-) | pCR DFS | 158 | 53.20% | 0.53(0.29–0.96) | 0.04 | NA |  |
157 | 36.90% | ||||||||||||||
(NCT01276769) | Pin Zhang-2016 | Oncotarget | Open-label | RCT | 2 | pac + Cb vs pacE | II-III | ER < 10% PR < 10% Her2(0–2 + FISH-) | pCR RFS OS | 47 | 38.60% | (RFS → DFS) 0.35(0.13–0.96) | 0.043 | 1.20(0.37–3.87) | 0.350 |
44 | 14.00% | ||||||||||||||
CALGB 40603 (NCT00861705) | William M.Sikov-2022 | J Clin Oncol | Open-label | RCT | 2 | pac + Cb + AC vs pac + AC | II-III | ER < 10% PR < 10% Her2(-) | pCR EFS OS | 221 | 54% | (EFS → DFS) 0.94(0.67–1.32) | 0.7210 | OS 1.12(0.77–1.61) | 0.5585 |
212 | 41% | ||||||||||||||
(ChiCTR-TRC-14005019) | Wenting Yan-2022 | Ther Adv Med Oncol | Open-label | RCT | 2 | TEL vs TE | I-III | ER < 10% PR < 10% Her2(0–2 + FISH-) | tpCR DFS OS | 99 | 41.40% | 0.44(0.21–0.90) | 0.028 | 0.44(0.18–1.02) | 0.061 |
101 | 17.80% | ||||||||||||||
Kun Wang (SABCS) | Kun Wang-2022 | SABCS | Open-label | RCT | 2 | wPCb-AC vs wP-AC | II | NA | DFS OS pCR | 365 | 55.20% | 0.79(0.61–1.02) | 0.073 | 0.75(0.57–0.98) | 0.034 |
355 | 41.50% | ||||||||||||||
I-SPY2 Trial(NCT01042379) | Nanda, R-2020 | JAMA Oncol | Open-label | RCT | 2 | P + pac + AC vs PBO + pac + AC | II-III | ER(-) PR(-) Her2(-) | pCR EFS | 29 | 60.00% | EFS → DFS 0.6(0.36–3.81) |  > 0.05 | NA | NA |
85 | 22.00% | ||||||||||||||
168 | 41.1% | ||||||||||||||
KEYNOTE-173(NCT02622074) | P. Schmid-2020 | Annals of Oncology | Open-label | RCT | 6 | P + Nab-pac + AC vs P + Nab-pac + Cb + AC vs P + Nab-pac + Cb + AC vs P + Nab-pac + Cb + AC vs P + pac + Cb + AC vs P + pac + Cb + AC | II-III | ER < 1% PR < 1% Her2(0–2 + FISH-) | pCR EFS OS | 10 | 60% | EFS → DFS NA | NA | NA | NA |
10 | 80% | ||||||||||||||
10 | 80% | ||||||||||||||
10 | 60% | ||||||||||||||
10 | 30% | ||||||||||||||
10 | 50% | ||||||||||||||
KEYNOTE-522(NCT03036488) | P. Schmid-2020 | New England Journal of Medicine | Open-label | RCT | 2 | P + pac + Cb + A/EC vs pbo + pac + Cb + A/EC | II-III | ER(-) PR(-) Her2(0–2 + FISH-) | pCR EFS | 784 | 64.80% | EFS → DFS 0.63(0.48–0.82) | P < 0.001 | NA |  |
390 | 51.20% | ||||||||||||||
GeparNuevo (NCT02685059) | S. Loibl-2022 | Annals of Oncology | Open-label | RCT | 2 | Dur + nab-pac vs PBO + nab-pac | I-III | NA | pCR iDFS DDFS OS | 88 | NA | DDFS → DFS 0.31(0.13–0.74) | 0.005 | 0.24(0.08–0.72) | 0.006 |
86 | NA | ||||||||||||||
BrighTNess(NCT02032277) | Sibylle Loibl-2022 | Annals of Oncology | Open-label | RCT | 3 | Paclitaxel + carboplatin + veliparib vs Paclitaxel + carboplatin + veliparib placebo vs Paclitaxel + carboplatin placebo  + veliparib placebo | I-III | ER < 1% PR < 1% Her2(0 or 1 +) | pCR EFS OS breast-conservation surgery | 316 | 53.00% | EFS → DFS 1.12(0.72–1.72) (1 vs 2) 0.56(0.34–0.93) (2 vs 3) | 0.62(1 vs 2) 0.02(2 vs 3) | 1.25 (0.70–2.24) (1 vs 2) 0.63 (0.33–1.21) (2 vs 3) | 0.46 (1 vs 2) 0.17 (2 vs 3) |
160 | 58.00% | ||||||||||||||
158 | 31.00% | ||||||||||||||
NSABP-B40(NCT00408408) | Harry D Bear-2015 | Lancet Oncol | Open-label | RCT | 2 | Bev +  vs Non-Bev | I-III | ER(-) PR(-) Her2(-) | pCR EFS | 592 | 51.10% | 0.8(0.63–1.01) | 0.06 | 0.65(0.49–0.88) | 0.004 |
594 | 47.10% | ||||||||||||||
GeparQuinto(NCT00567554) | G. von Minckwitz-2014 | Annals of Oncology | Open-label | RCT | 2 | ECB-DB vs EC-D | II-III | ER (< 10%) PR (< 10%) Her2(0–2 + FISH-) | pCR DFS OS | 323 | 39.30% | 1.03(0.84–1.25) | 0.784 | 0.97(0.75–1.26) | 0.842 |
340 | 27.90% | ||||||||||||||
SWOG S0800(NCT00856492) | Z. A. Nahleh-2016 | Breast Cancer Res Treat | Open-label | RCT | 2 | Bev + nab-pac + ddAC vs Non-Bev-based | IIB—IIIC | ER(-) PR(-) Her2(-) | pCR DFS OS | 98 | 59.40% | EFS → DFS 0.46(0.2–1.05) | 0.06 | 0.49(0.19–1.29) | 0.14 |
113 | 28.60% | ||||||||||||||
ARTemis(NCT01093235) | H. M. Earl-2017 | Annals of Oncology | Open-label | RCT | 2 | Bev + D-FEC vs D-FEC | NA | (ER) status as negative when Allred score was 0–2/8; ER weakly positive was 3–5/8; and ER strongly positive was 6–8/8 Her2(0–2 + FISH-) | pCR DFS OS | 388 | 22.00% | 1.18(0.89–1.57) | 0.25 | 1.26(0.9–1.76) | 0.19 |
393 | 17.00% |