Table 1.
Randomized phase III trials of chemotherapy and trastuzumab in the neoadjuvant setting.
| Study [ref.] | n | Stage | Neoadjuvant therapy | pCR rate % (definition) |
|---|---|---|---|---|
| MDAnderson [Buzdar et al. 2005] 2nd cohort [Buzdar et al. 2007] |
42 22 |
II-IIIA | P/3 weeks (4C) → FEC (4C) ± concomitant weekly trastuzumab |
65% versus 26% 55% (ypT0/is ypN0) |
| NOAH [Gianni et al. 2010] | 235 | Only LABC (26% cT4d) |
A + P/3 weeks (3C) → P/3 weeks (4C) → CMF (3C) ± concomitant 3 weeks trastuzumab |
38% versus 19% (ypT0/is ypN0) |
| GeparQuattro [Untch et al. 2010] | 445 | II-III (10% cT4d) |
EC × 4 → D [X] + concomitant trastuzumab/3 weeks |
40% (ypT0/is ypN0) |
| ACOSOG Z1041 [Buzdar et al. 2013] | 282 | II-III (8% cN3) |
FEC-75 (4C) → weekly P + trastuzumab × 12 weeks versus Weekly P × 12 weeks → FEC-75 (4C) + concomitant weekly trastuzumab |
56.5% versus 54.2% (ypT0/is) |
| HannaH [Ismael et al. 2012] | 596 | II-III | D (4C) → FEC-75 (4C) + concomitant 3 weeks trastuzumab intravenously or subcutaneously | 34% versus 39% (ypT0/is ypN0) |
A, adriamicine; C, cycle; D, docetaxel; FEC, 5 fluorouracil + epirubicin + cyclophosphamide; LABC, locally advanced breast cancer; P, paclitaxel; pCR, pathological complete response; CMF, cyclophosphamide, methotrexate and fluorouracil; X, capecitabine.