Author | Study description | Treatment | Patient population | % 1L | % 2L | % 3L+ | N‡ | ORR‡ % | DOR, months | PFS, months | OS, months | % TNBC patients |
---|---|---|---|---|---|---|---|---|---|---|---|---|
NCCN-recommended (v1.2016) monotherapies | ||||||||||||
 Aftimos et al. [23] | Retrospective phase III sub-group analysis | Eri | 2L+ MBC w/mTNBC | 0 | 100 | 22 | 18 | N/R | N/R | N/R | 17 | |
 Awada et al. [24] | Phase II | Pac | 1L mTNBC | 100 | 0 | 0 | 28 | 28.6 | N/R | 3.5 | 13.1 | 100 |
 Baselga et al. [25] | Phase II | Cis | 1L–2L mTNBC | 72 | 28 | 0 | 60 | 10 | N/R | 1.5 | 9.4 | 100 |
Phase II | Cis | 1L mTNBC | Â | Â | Â | 42 | 12 | N/R | N/R | N/R | 100 | |
Phase II | Cis | 2L mTNBC | Â | Â | Â | 16 | 6 | N/R | N/R | N/R | 100 | |
 Brufsky et al. [26] | RIBBON-2 | Physician’s choice chemo | 2L MBC w/mTNBC | 0 | 100 | 0 | 47 | 18 | N/R | 2.7 | 12.6 | 21 |
 Isakoff et al. [27] | Phase II | Car/cis | 1L–2L mTNBC | 80 | 20 | 0 | 86 | 25.6 | N/R | 2.9 | 11 | 100 |
Phase II | Car/cis | 1L mTNBC | Â | Â | Â | 69 | 29 | N/R | N/R | N/R | 100 | |
Phase II | Car/cis | 2L mTNBC | Â | Â | Â | 17 | 11.8 | N/R | N/R | N/R | 100 | |
 Miles et al. [28] | RIBBON-1 + AVADO + E2100 pooled subgroup | Cap/doc/pac | 1L MBC w/mTNBC | 100 | 0 | 0 | 255 | 23.3 | N/R | 5.4 | 17.5 | 26 |
 Perez et al. [29] | BEACON | Physician’s choice chemo | 3L+ MBC w/mTNBC | 0 | 0 | 100 | 117 | N/R | N/R | N/R | 8.8 | 28 |
 Pivot et al. [30] | Prespecified phase III subgroup | Cap | 1L–3L+ MBC w/mTNBC | 9 | 49 | 43 | 96 | 9 | N/R | 2.1 | N/R | 25 |
 Sparano et al. [31] | Phase III | Cap | 1L–3L+ MBC w/mTNBC | 19 | 63 | 18 | 134 | N/R | N/R | 1.81 | N/R | 22 |
 Study 301†| Phase III subgroup | Cap | 1L MBC w/mTNBC |  |  |  | 40 | 12 | 4.4 | N/R | 9.9 | 24.5 |
Eri | 1L MBC w/mTNBC | Â | Â | Â | 40 | 10.4 | 6.6 | N/R | 13.1 | 27.1 | ||
Phase III subgroup | Cap | 2L+ MBC w/mTNBC |  |  |  | 96 | ~ 10 | 5.9 | 2.8 | 9.2 | 24.5 | |
Eri | 2L+ MBC w/mTNBC |  |  |  | 110 | ~ 10 | 4.2 | 3.4 | 15.2 | 27.1 | ||
 Tredan et al. [32] | Phase II | Ixa | 1L mTNBC | 100 | 0 | 0 | 40 | 30 | 4.5 | 4.1 | N/R | 100 |
EMBRACE + 301 pooled subgroup | Eri | 1L–3L+ MBC w/mTNBC | 11 | 27 | 62 | 243 | 12 | N/R | 2.8 | 12.9 | 22.9 | |
EMBRACE + 301 pooled subgroup | Eri | 2L+ MBC w/mTNBC |  |  |  | 199 | 11 | N/R | 2.8 | 12.4 | 22.9 | |
EMBRACE + 301 pooled subgroup | Physician’s choice chemo | 1L–3L+ MBC w/mTNBC | 13 | 37 | 50 | 185 | 10.3 | N/R | 2.6 | 8.2 | 23.1 | |
EMBRACE + 301 pooled subgroup | Physician’s choice chemo | 2L+ MBC w/mTNBC |  |  |  | 153 | 9 | N/R | 2.5 | 8.1 | 23.1 | |
 von Minckwitz et al. [33] | TANIA | Physician’s choice chemo | 2L MBC w/mTNBC | 0 | 100 | 0 | 57 | N/R | N/R | 2.1 | N/R | 23 |
NCCN-v1.2016-recommended combination therapies | ||||||||||||
 Brodowicz et al. [34]§ | TURANDOT | Bev+pac | 1L MBC w/mTNBC | 100 | 0 | 0 | 63 | 49 | N/R | 9 | 24.2 | 22 |
 Dieras et al. [35] | Phase II | Bev+pac | 1L–2L mTNBC | 81 | 19 | 0 | 61 | 47.53 | 7.5 | 7.2 | 17.4 | 100 |
Phase II | Bev+pac | 1L mTNBC | Â | Â | Â | 46 | N/R | N/R | 7.2 | N/R | 100 | |
Phase II | Bev+pac | 2L mTNBC | Â | Â | Â | 16 | N/R | N/R | 7 | N/R | 100 | |
 Fan et al. [36] | Phase II | Doc+cap | 1L mTNBC | 100 | 0 | 0 | 26 | 15.4 | N/R | 4.8 | 21.5 | 100 |
 Halim et al. [37] | Phase II | Car+pac | 2L+ mTNBC | 0 | 100 | 50 | 60 | N/R | N/R | N/R | 100 | |
 Li et al. [38] | Phase II | Cap+cis | 1L–3L mTNBC | 84.9 | 12.1 | 3 | 33 | 63.6 | N/R | 8.2 | 17.8 | 100 |
Phase II | Cap+cis | 1L mTNBC | Â | Â | Â | 28 | 64.3 | N/R | 8.2 | 19.6 | 100 | |
Phase II | Cap+cis | 2L–3L mTNBC |  |  |  | 5 | 60 | N/R | 5.1 | 16.5 | 100 | |
 Liao et al. [39] | Phase II | Doc+cap | 1L mTNBC | 100 | 0 | 0 | 27 | 14.8 | N/R | 4.9 | 21.5 | 100 |
 Liao et al. [39] | Phase II | Vin+cap | 1L mTNBC | 100 | 0 | 0 | 18 | 27.8 | N/R | 5.2 | 18.2 | 100 |
 Miles et al. [28]* (many combinations with high ORR—OS is still not much higher) | Pooled phase III (E2100, AVADO, RIBBON-1) | Bev+(cap/doc/pac/nab-pac/(dox/epi/CP/ FU)) | 1L MBC w/mTNBC | 100 | 0 | 0 | 360 | 42.3 | N/R | 8.1 | 18.9 | 25 |
 O’Shaughnessy et al. [40] | Phase III | Gem+car | 1L–3L mTNBC | 58 | 42 | 244 | 32 | N/R | 4.1 | 11.1 | 100 | |
Phase III | Gem+car | 1L mTNBC | Â | Â | Â | 149 | N/R | N/R | 4.6 | 13.9 | 100 | |
Phase III | Gem+car | 2L–3L mTNBC |  |  |  | 109 | N/R | N/R | 2.9 | 8.1 | 100 | |
 Pivot et al. [30] | Prespecified phase III subgroup | Ixa+cap | 1L–3L+ MBC w/mTNBC | 7 | 48 | 45 | 91 | 27 | N/R | 4.1 | N/R | 24.3 |
 Rugo et al. [41] | Phase III | Bev+nab-pac | 1L MBC w/mTNBC | 100 | 0 | 0 | 65 | N/R | N/R | 7.4 | N/R | 24 |
 Rugo et al. [41] | Phase III | Bev+ixa | 1L MBC w/mTNBC | 100 | 0 | 0 | 63 | N/R | N/R | 5.6 | N/R | 26 |
 Rugo et al. [41] | Phase III | Bev+pac | 1L MBC w/mTNBC | 100 | 0 | 0 | 73 | N/R | N/R | 6.5 | N/R | 26 |
 Sparano et al. [31] | Phase III | Ixa+cap | 1L–3L+ MBC w/mTNBC | 20 | 61 | 19 | 122 | N/R | N/R | 4.2 | N/R | 20 |