Table 1.
Randomized trials with neoadjuvant trastuzumab.
| Study (ref.) | No. of patients | Clinical stage | Neoadjuvant chemotherapy | pCR rate (%) | cCR (%) | Breast-conserving surgery rate (%) |
|---|---|---|---|---|---|---|
|
Buzdar et al. [4, 5], phase III |
42 | II–IIIA | P (4 c) → FEC (4 c) | *Trastuzumab: 65% *No trastuzumab: 26% |
Trastuzumab: 87% No trastuzumab: 47% |
Trastuzumab: 53% No trastuzumab: 56.5% |
| H2269s [6], phase II |
30 | II-III | Doc + carboplatin (4 c) |
†Trastuzumab: 40% †No trastuzumab: 7.1% |
NR | NR |
| ABCSG-24 [7], phase III |
90 | T1–4 (except T4d), any N | ED ± Cap (6 c) |
#Trastuzumab: 40% #No trastuzumab: 26.7% |
NR | Trastuzumab: 69% No trastuzumab: 79% |
| NOAH [8], phase III |
235 | T3N1, T4, or any T N2-3 | Doxo + P (3 c) → P (4c) → CMF (3 c) | *Trastuzumab: 38% *No trastuzumab: 19% |
Trastuzumab: 87% No trastuzumab: 74% |
‡Trastuzumab: 23% ‡No trastuzumab: 13% |
| REMAGUS 2 [9], phase II | 120 | II-III | EC (4 c) → Doc (4 c) | *Trastuzumab: 26% *No trastuzumab: 19% |
Trastuzumab: 34% No trastuzumab: 22% |
Trastuzumab: 47% No trastuzumab: 47% |
pCR: pathologic complete response; cCR: clinical complete response; NR: not reported; P: paclitaxel; FEC: 5-fluorouracil + epirubicin + cyclophosphamide; Doc: docetaxel; ED: epirubicin + docetaxel; Cap: capecitabine; Doxo: doxorubicine; CMF: cyclophosphamide + methotrexate + 5-fluoro-uracile; EC: epirubicin + cyclophosphamide.
pCR: *no invasive residual tumor in breast and axilla; †no invasive residual tumor in breast only; #definition not reported.
‡[11].