Table 2.
Selected clinical trials in the neo-adjuvant setting for human epidermal growth factor receptor-2 positive breast cancer
| Study | Neo-adjuvant chemotherapy | No. of patients | Pathological complete response (%) | Comments | Ref. |
| Trastuzumab (H) | |||||
| MD Anderson Group | T → FEC vs T → FEC + H | 19 vs 23 | 26% (95%CI: 9%-51%) vs 65% (95%CI: 43%-84%) | Probably the first study to emphasize better pCR with H | Buzdar et al[24] |
| The NOAH Trial | A + T → T → CMF vs A + T → T → CMF + H | 117 HER-2 (+) vs 118 HER-2 (+) | 22% (95%CI: not reported) vs 43% (95%CI: not reported) | Not originally designed to test the effects of neoadjuvance | Gianni et al[26] |
| The TECHNO Trial | EC → TH | 217 | 38.7% (95%CI: 32%-45%) | Suggest pCR correlate with DFS | Untch et al[27] |
| The Z1041 Trial | FEC → TH vs T + H → FEC + H | 138 vs 142 | 56.5% (95%CI: 48%-65%) vs 54.2% (95%CI: 46%-62%) | Concurrent use of H with anthracyclines is not better | Buzdar et al[28] |
| The HannaH Trial | Doc + H (SQ) → FEC + H vs Doc + H (IV) → FEC + H | 260 vs 263 | 45.4% (95%CI: 39%-52%) vs 40.7% (95%CI: 35%-47%) | H can be administered subcutaneously | Ismael et al[30] |
| Lapatinib(L) +/- (H) | |||||
| The GeparQuinto Trial | ECH → TH vs ECL → TL | 309 vs 311 | 30.3% (95%CI: 25%-36%) vs 22.7% (95%CI: 18%-28%) | Lapatinib is less effective that H | Untch et al[31] |
| The NeoALLTO Trial | TH vs TL vs THL | 149 vs 154 vs 152 | 29.5% (22%–37%) vs 24.7% (22% -37%) vs 51.3% (43%-59%) | Suggested that combination H + L could be quite effective | Baselga et al[32] |
| The NSABP B-41 Trial | AC → TH or TL or THL | 181 vs 174 vs 174 | 52.5% (50%-59.5%) vs 53.2% (45%-60%) vs 62.0% (54%-69%) | H + L no better. All patients received anthracyclines | Robidoux et al[33] |
| Pertuzumab (P) | |||||
| The NeoSphere Trial | Do + H vs Do + P + H vs Do + P vs P + H | 107 vs 107 vs 107 vs 96 | 29.0% (21%-38.5%) vs 45.8% (36%-56%) vs 24.0% (16%-34%) vs 16.8% (10%-25%). | Combination P + H result in better pCR. | Gianni et al[34] |
| The Tryphaena Trial (Abstract Only) | FEC + HP → Do + HP vs FEC → Do + HP vs TCHP | 223 patients in total | 62% vs 57% vs 66% | TCH + P is an active combination | N/A |
T: Paclitaxel; F: 5-FU; E: Epirubicin; C: Cyclophosphamide; A: Adriamycin; M; Methotrexate; Do: Docetaxel; TC: Docetaxel carboplatin.