Table 1.
Neoadjuvant Trials in HER2-positive breast cancer.
| Trial | Phase | Treatment | Treatment arms | Survival | N | pCR rate |
|---|---|---|---|---|---|---|
| Trastuzumab | ||||||
| NOAH (14) | III | Trastuzumab | DTCMF + H | EFS (3y) 71% OS (3y) 87% |
117 | 38% |
| DTCMF | EFS (3y) 56% OS (3y) 79% |
118 | 19% | |||
| GeparQuattro (15) | III | Trastuzumab | H + EC → H + Dc | 146 | 33% | |
| H + EC → H + DcCp | 47 | 31% | ||||
| H + EC → H + Dc → H + Cp | 136 | 35% | ||||
| TECHNO (16) | II | Trastuzumab | EC → HT | DFS (3y) 77.9% OS (3y) 89.4% |
217 | 39% |
| Trastuzumab + Lapatinib | ||||||
| NeoALTTO (24) | III | Lapatinib + Trastuzumab | LH → HT | EFS (6y) 74% OS (6y) 85% |
68 | 47% |
| H → HT | EFS (6y) 67% OS (6y) 82% |
40 | 28% | |||
| L → HT | EFS (6y) 67% OS (6y) 79% |
30 | 20% | |||
| CHER-LOB (22) | II | Lapatinib + Trastuzumab | LH → TFEC + LH | RFS (5y) 86% | 46 | 47% |
| H → TFEC + H | RFS (5y) 78% | 36 | 25% | |||
| L → TFEC + L | RFS (5y) 77% | 38 | 26% | |||
| CALGB 40601 (23) | III | Lapatinib + Trastuzumab | THL | RFS (7y) 93% OS (7y) 96% |
118 | 57% |
| TH | RFS (7y) 79% OS (7y) 88% |
120 | 45% | |||
| TL | RFS (7y) 69% OS (7y) 84% |
67 | 30% | |||
| NSABP B-41 (33) | III | Trastuzumab + Lapatinib | DC + H → T + H | DFS (5y) 84.3% OS (5y) 94.5% |
177 | 49.4% |
| DC + L → T + H | DFS (5y) 78.6% OS (5y) 89.4% |
159 | 47.4% | |||
| DC + LH → T + H | DFS (5y) 90% OS (5y) 95.7% |
165 | 60.2% | |||
| Lapatinib | ||||||
| GeparQuinto (34) | III | Lapatinib | ECH → Dc + H | DFS (3y) 84.8% OS (3y) 91.7% |
307 | 30.3% |
| ECL → Dc + L | DFS (3y) 83.7% OS (3y) 93.6% |
308 | 22.7% | |||
| Trastuzumab + Pertuzumab | ||||||
| NeoSphere (35) | II | Pertuzumab + Trastuzumab | H + Dc | PFS (5y) 81% DFS (5y) 81% |
107 | 29% |
| HP + Dc | PFS (5y) 86% DFS (5y) 84% |
107 | 46% | |||
| HP | PFS (5y) 73% DFS (5y) 80% |
107 | 17% | |||
| P + Dc | PFS (5y) 73% DFS (5y) 75% |
96 | 24% | |||
| TRYPHAENA (29) | II | Pertuzumab + Trastuzumab | FEC + HP → Dc + HP | DFS (3y) 87% PFS (3y) 89% OS (3y) 94% |
73 | 62% |
| FEC → Dc + HP | DFS (3y) 88% PFS (3y) 89% OS (3y) 94% |
75 | 57% | |||
| Dc + Cb + HP | DFS (3y) 90% PFS (3y) 87% OS (3y) 93% |
77 | 66% | |||
| GeparSepto (36) | III | Pertuzumab + Trastuzumab | T + HP → EC + HP | iDFS (4y) 89% | 199 | 54% |
| Nab-T + HP → EC + HP | 197 | 62% | ||||
| ADAPT HER2+/HR- (37) | II | Pertuzumab + Trastuzumab | HP | iDFS (5y) 87% OS (5y) 94% |
92 | 34% |
| HP + T | iDFS (5y) 98% OS (5y) 98% |
42 | 90% | |||
| BERENICE (30, 38) | II | Pertuzumab + Trastuzumab | dd D + C → T + HP | EFS (5y) 91% OS (5y) 96% |
199 | 62% |
| FEC → Dc + HP | EFS (5y) 89% OS (5y) 94% |
201 | 61% | |||
| TRAIN-2 (28) | III | Pertuzumab + Trastuzumab | FEC (x3) → TCb + HP (x6) | EFS (3y) 93% OS (3y) 98% |
211 | 67% |
| TCb + HP (x9) | EFS (3y) 94% OS (3y) 98% |
206 | 68% | |||
| PHERGain (39) | II | Pertuzumab + Trastuzumab | DcCb + HP | 71 | 58% | |
| HP | 285 | 35% | ||||
| PREDIX HER2 (40) | II | Pertuzumab + Trastuzumab | Dc + HP | 99 | 46% | |
| T-DM1 + Pertuzumab | ||||||
| KRISTINE (32) | III | T-DM1 + Pertuzumab | T-DM1 + P | EFS (3y) 85% iDFS (3y) 93% |
223 | 44% |
| DcCb + HP | EFS (3y) 94% iDFS (3y) 92% |
221 | 56% | |||
H- trastuzumab; P- pertuzumab; T- paclitaxel; D- doxorubicin; C- cyclophosphamide; M- methotrexate; F- fluorouracil; L- lapatinib; E- epirubicin; Dc- docetaxel; Cp- capecitabine; Cb- carboplatin, Nab-T- nab-paclitaxel; dd- dose dense; T-DM1- trastuzumab emtansine.