Background
Methods
Results
Study, author, year | Type of study | N (ITT) | Patient population or stage of disease | Regimen | pCR definition | Overall pCR, % | Subgroup pCR, % |
P
|
---|---|---|---|---|---|---|---|---|
Unselected (all subtypes; n = 7) | ||||||||
GeparSepto, Untch, 2016 [11] | Phase III | 1229 | High-risk early-stage BC |
nab-P 125 (150 before amendment) mg/m2 qw | ypT0 ypN0 | 38.4 | TNBC, 48.2% | Overall, <0.001 |
Pac 80 mg/m2 qw | 29.0 | TNBC, 26.3% | TNBC, <0.001 | |||||
Huang, 2015 [9] | Phase II | 120 | Stage II–III |
nab-P 125 mg/m2 + carbo AUC 2 qw every 21 days (+trastuz if HER2+) | ypT0/is ypN0 |
nab-P, 26.7 | NR | 0.904 |
Pac 80 mg/m2 + carbo AUC 2 qw every 21 days (+trastuz if HER2+) | Pac, 25.6 | |||||||
Shigematsu, 2015 [10] | Phase II | 55 | Operable T1c3N02M0 |
nab-P 260 mg/m2 q3w + cyclophosphamide 600 mg/m2 → FEC q3w | Necrosis and/or absence of all tumor cells or replacement of cancer cells with granulation and/or fibrosis in breast and axilla | 37 | HR+/HER2−: 8 HR+/HER2+: 56 HR−/HER2+: 63 TNBC: 62 | NA |
Seki, 2015 [57] | Phase II | 40 | Stage I–III |
nab-P 80 mg/m2 qw 3/4 → FEC q3w | ypT0/is ypN0 | 40 | Luminal A: 20 Luminal B/HER2−: 15.4 Luminal B/HER2+: 60 HER2 enriched: 80 TNBC: 42.9 | NA |
Neonab, Khasraw, 2015 [58] | Phase II | 40 | Stage II–III | EC → nab-P 125 mg/m2 qw 3/4 (+trastuz if HER2+) | NR | NA | NA | NA |
Tsugawa, 2014 [59] | Phase II | 34 | cT1c-3/N0-1/M0 or T1/N1/M0 |
nab-P 150 mg/m2 qw 3/4 → FEC q3w | ypT0/is N0 | 27 | ER+: 9 ER−: 58 | NA |
Khan, 2015 [12] | Phase II | 32 | Stage II–III operable BC with low HER2 expression |
nab-P 100 mg/m2 + trastuz (4 mg/kg, then 2 mg/kg) qw → ddAC | In breast and axilla | 22 | In axilla of patients with positive axillary biopsy: 53 In breast of patients with grade 3 tumors: 41 | NA |
HER2− or TNBC (n = 9) | ||||||||
SWOG S0800, Nahleh, 2014 [14] | Phase II | 215 | HER2− IBC or LABC |
nab-P 100 mg/m2 qw + bev → ddAC + PEG-G | ypT0 ypN0 | 28 | With bev: 36 | 0.021 |
nab-P 100 mg/m2 → ddAC + PEG-G vs AC + PEG-G followed by nab-P | No bev: 21 | |||||||
Kuwayama, 2015 [19] | Phase II | 152 | Stage II–III HER2− |
nab-P 100 mg/m2 qw 3/4 → FE100C | ypT0/is ypN0 | 17 | TNBC: 30 | Overall, 0.323 TNBC, 0.866 |
Docetaxel 75 mg/m2 q3w → FE100C | 12 | TNBC: 28 | ||||||
Phase II | 130 | TNBC |
nab-P 125 mg/m2 qw 2/3 + carbo AUC 2 | ypT0 ypN0 | 49.2 | <0.001006 | ||
nab-P 125 mg/m2 qw 2/3 + gem 1000 mg/m2 qw 2/3 | 25.0 | |||||||
GEICAM, Martin, 2014 [13] | Phase II | 81 | HER2−/ER+ |
nab-P 150 mg/m2 qw 3/4 | RCB 0 + 1 | 24.7 | ER+: 23.3 HER2−: 23.3 | NA |
TBCRC 008, Connolly, 2015 [15] | Phase II | 62 | Operable stage II–III T1c, cN1-3 or T2-4, any N (all M0) HER2− |
nab-P 100 mg/m2 + carbo AUC 2 qw + vorinostat 400 mg qd on days 1–3 of each week | No invasive cancer in breast and axilla | 25.8 | NR | |
nab-P 100 mg/m2 + carbo AUC 2 qw + placebo | 29.0 | |||||||
Somlo, 2015 [60] | Phase II | 49 | Stage II-III LABC or IBC |
nab-P 100 mg/m2 d1, 8, 15, and 22 + carbo AUC 6 d1 (4 × 28-day cycles) | pCR; RCB 0 + 1 | 53; 65 | NR | NA |
Mrozek, 2014 [61] | Phase II | 33 | Stage II–III HER2− |
nab-P 100 mg/m2 + carbo AUC 2 qw 3/4 + bev q2w 10 mg/kg | ypT0 ypN0 | 18 | TNBC: 50 | NA |
Matsuda, 2015 [62] | Phase II | 25 | HER2− IBC | Panitumumab 2.5 mg/kg + nab-P 100 mg/m2 + carbo AUC 2 → FEC | RCB 0 | 33 | HR+: 38 TNBC: 62 | NA |
Shimada, 2015 [20] | Institutional | 53 | Stage II–III HER2− |
nab-P 260 mg/m2 q3w → by EC | ypT0/is ypNany
| 5.7 | HR+: 2.9 TNBC: 10.5 | NA |
HER2+ (n = 3) | ||||||||
Sinclair, 2013 [21] | Phase II | 60 | Stage II–III | Carbo + nab-P 100 mg/m2 qw + trastuz qw (4 mg/kg loading, then 2 mg/kg/wk) | No invasive cancer in breast and axilla | 45 | ER+: 40 ER−: 52 | NA |
Tanaka, 2015 [22] | Phase II | 46 | Stage I–III | Anthracycline → nab-P 260 mg/m2 + trastuz q3w | ypT0/is ypN0 | 49 | ER+: 36 ER−: 71 | NA |
Zelnak, 2015 [23] | Phase II | 27 | Stage I–III |
nab-P 260 mg/m2 q2w → vinorelbine 25 mg/m2 qw + trastuz qw (4 mg/kg loading, then 2 mg/kg/wk) | No invasive cancer in breast and axilla | 48.1 | ER/PR+: 18.2 ER/PR−: 68.8 | NA |
Study, author, year | Type of study | N (ITT) | Patient population or stage of disease | Line of therapy | Regimen | PFS, months, median | OS, months, median |
---|---|---|---|---|---|---|---|
Unselected (all subtypes; n = 5) | |||||||
CALGB 40502, Rugo, 2015 [30] | Phase III | 799 | Stage IIIC or IV locally recurrent or MBC | First | Beva + paclitaxel 90 mg/m2 qw 3/4 | 11 | 27.4b
|
Bev + nab-P 150 mg/m2 qw 3/4 | 9.3 | 23.5 | |||||
Bev + ixabepilone 16 mg/m2 qw 3/4 | 7.4 | 23.6 | |||||
Jain, 2016 [32] | Phase II/III | 180 | MBC | Multiple (all lines) |
nab-P 260 mg/m2 q3w | 7.8 | NR |
PICN 260 mg/m2 q3w | 5.3 | NR | |||||
PICN 295 mg/m2 q3w | 8.1 | NR | |||||
Sun, 2014 [31] | Phase II | 73 | MBC | Multiple (all lines) |
nab-P 125 mg/m2 qw 3/4 → cisplatin 75 mg/m2 q4w | 9.8 | 26.9 |
Dent, 2013 [63] | Retrospective | 43 | MBC | Multiple (all lines) |
nab-P 260 mg/m2 q3w | NR | 10.8 |
nab-P 100 mg/m2 qw 3/4 | 13.6 | ||||||
Aigner, 2013 [64] | Retrospective | 36 | MBC | Multiple (all lines) |
nab-P 100-150 mg/m2 qw | 7.5 | 14.2 |
HER2− or TNBC (n = 4) | |||||||
TBCRC 019, Forero-Torres, 2015 [37] | Phase II | 64 | Metastatic TNBC | Multiple (all lines) |
nab-P 100 mg/m2 qw 3/4 + tigatuzumab (10 mg/kg, then 5 mg/kg q2w) | 2.8 | NR |
nab-P 100 mg/m2 qw 3/4 | 3.7 | ||||||
Palumbo, 2015 [38] | Phase II | 52 | HER2− MBC | Second |
nab-P 260 mg/m2 q3w | 8.9 | Not yet reached |
Hamilton, 2013 [65] | Phase II | 34 | Metastatic TNBC | First |
nab-P 100 mg/m2 qw 3/4 + carbo AUC 2 qw 3/4 + bev 10 mg/kg q2w | 9.2 | NR |
Studies of nab-paclitaxel in early-stage breast cancer
Unselected (all subtypes)
HER2-negative or TNBC
HER2-positive
Post hoc analyses
Adjuvant treatment with nab-paclitaxel
Ongoing trials in early-stage breast cancer
Studies of nab-paclitaxel in MBC
Unselected (all subtypes)
HER2-negative or TNBC
Health economic analyses
Ongoing trials in MBC
Study, ClinicalTrials.gov identifier | Phase | Planned N | Patient population or stage of disease | Regimen | Primary endpoint |
---|---|---|---|---|---|
Early-stage (n = 4) | |||||
GAIN-2, NCT01690702 [66] | III | 2886 | High risk, after R0 resection | Adjuvant epirubicin 150 mg/m2 q2w × 3 cycles → nab-P 260-330 mg/m2 × 3 cycles (TBD in run-in-phase) q2w → cyclophosphamide 2000 mg/m2 q2w × 4 cycles | iDFS |
EC q2w → docetaxel q2w | |||||
ETNA, NCT01822314 | III | 632 | High risk HER2− | Neoadjuvant nab-P 125 mg/m2 qw 3/4 × 4 cycles → AC, EC, or FEC × 4 cycles | pCR |
Neoadjuvant paclitaxel 90 mg/m2 qw 3/4 × 4 cycles → AC, EC, or FEC × 4 cycles | |||||
NCT00618657 | II | 120 | Stage I–III | Neoadjuvant nab-P + carbo + trastuz for HER2+ qw × 12 weeks | PFS |
Neoadjuvant nab-P + carbo qw × 12 cycles + bev q2w × 5 cycles for HER2− | |||||
NCT02530489 | II | 37 | TNBC nonmetastatic | Neoadjuvant nab-P 100 mg/m2 + atezolizumab | pCR |
NCT02489448 | I/II | 61 | Stage I–III TNBC | Neoadjuvant durvalumab + nab-P qw × 12 cycles → ddAC × 4 cycles | pCR (ypT0/Tis, ypN0) |
Metastatic or advanced stage (n = 12) | |||||
PERUSE, NCT01572038 [43] | III | 1500 | HER2+ | Trastuz + pertuzumab + taxane of choice | Safety |
IMpassion130, NCT02425891 | III | 350 | Untreated locally advanced or metastatic TNBC |
nab-P + atezolizumab | PFS |
nab-P + placebo | |||||
tnAcity, NCT01881230 [48] | II/III | 790 | TNBC | Selected nab-P regimen from phase II portion (either nab-P 125 mg/m2 + gem 1000 mg/m2 d1, 8 q3w or
nab-P 125 mg/m2 + carbo AUC 2 d1, 8 q3w) | PFS |
Gem 1000 mg/m2 + carbo AUC 2 d1, 8 q3w | |||||
SNAP, NCT01746225 [48] | II | 258 | HER2− MBC | Induction nab-P 125 mg/m2 qw 3/4 × 3 cycles in all patients → randomization into 3 arms: nab-P 150 mg/m2 q2w | ORR by RECIST v1.1 |
nab-P 100 mg/m2 qw 3/4 | |||||
nab-P 75 mg/m2 qw | |||||
NCT00733408 | II | 63 | MBC | Induction nab-P qw 3/4 + bev q2w → maintenance with bev q2w or q3w + erlotinib qd | PFS |
NCT01730833 | II | 50 | Stage II–IV HER2+ LABC and MBC | Pertuzumab q3w + trastuz qw + nab-P qw | PFS |
NCT01463072 | II | 40 | LABC or MBC in ≥65-year-old patients |
nab-P qw 3/4 | Tolerability |
PembroPlus, NCT02331251 | I/II | 90 | MBC and other solid tumor types | Pembrolizumab + chemotherapy, including nab-P | RP2D |
NCT02379247 | I/II | 54 | Locally recurrent BC or MBC | PI3K inhibitor BYL719 + nab-P 100 mg/m2 qw 3/4 | Phase I, RP2D; phase II, ORR |
NCT01938833 | I/II | 47 | Metastatic inflammatory BC |
nab-P + romidepsin qw 3/4 | MTD, PFS |
STELA, NCT02073916 [46] | I/II | 45 | HER2+ MBC | T-DM1 + lapatinib + nab-P | MTD |
NCT02309177 | I | 138a
| Recurrent MBC and other solid tumor types | Nivolumab + nab-P 100 mg/m2 qw 3/4a
| DLTs, safety |
Nivolumab + nab-P 260 mg/m2 q3wa
|