|
| Trial | Phase () | Tumors | Treatment | Primary endpoint | Other outcomes | Ref. |
|
| Buzdar et al. | III (42/164) | HER2+, II-IIIA | 4 × Pac → 4 × FEC ± H (24 × weekly) | pCR 67 versus 25% ();
(closed early because of pCR difference) | cORR 96 versus 84% ( = na);
no clinical cardiac failure;
>10% decrease in LVE 7 versus 5 patients | [28] |
|
| NOAH | III (99 Her2+/343) | T3 N1 or T4 or N2-3 | 3 × APac → 4 × Pac → 3 × CMF ± H | 3 y-EFS 71 versus 56% () | bpCR 43 versus 22% ();
tpCR 38 versus 19% ();
3 y-OS 87 versus 79% ();
despite concurrent administration
with doxorubicin CHF only 2% | [16] |
|
| GeparQuattro | III (445 HER2+/1509) | T1c–4d N0–3 (N0 only if HR−) | 4 × EC → 4 × Doc
+ H (HER2+) ± X (combination or sequence) | tpCR 32 versus 16% () | BCT 63 versus 65% (ns);
pCR Doc versus Doc + X versus Doc→ X
22 versus 20 versus 22% (ns);
BCT 70 versus 68 versus 65% (ns) | [12, 30] |
|
| TECHNO | II (217) | HER2+, ≥2 cm or cT4d | 4 × EC → 4 × Pac
+ H | pCR 39% | BCT 65%; CHF 3.7%
3 y-DFS 78%
3 y-DFS pCR versus non: 96 versus 86% () | [29] |
|
| GeparQuinto (Her2 positive) | III (620) | cT3/4; cT2 if HR− or cN+; cT1 if HR− or SLN+ | 4 × EC → 4 × Doc
+ H versus L | pCR 30 versus 23% () | cORR 90% both (ns)
diarrhea ≥ gr 3: 3 versus 12% ()
CHF 1 versus 7 (ns) | [34] |
|
| CHER-LOB | II (121) | HER2+, II-IIIA | 12 × Pac → 4 × FEC + H versus L versus L + H | pCR 25 versus 26 versus 47% (L/H versus L + H: = .019) | BCT 67 versus 58 versus 70%;
diarrhea ≥ gr 3: 3 versus 36 versus 35% | [32] |
|
| NEO-ALTTO | III (455) | HER2+, ≥2 cm | 6 × H (w) versus L versus L + H (w) → combination with 12 × Pac (w) → S → FEC + same schedule for 1 y | pCR 30 versus 25 versus 51% (H versus L + H: ; H versus L: ) | cORR after 6 weeks 30 versus 53 versus 67% (both );
cORR at surgery 71 versus 74 () versus 80% ();
diarrhea ≥ gr 3: 2 versus 23 versus 21% | [63] |
|
| NSABP B-41 | III (522) | HER2+, ≥2 cm | 4 × AC → 4 × Doc + H (w) versus L versus L + H (w) (+H for 1 y adjuvant for all) | pCR 53 versus 53 versus 62% (H versus L + H: ; H versus L: ) | diarrhea ≥ gr 3: 2 versus 20 versus 27% ()
CHF ≥ gr 3: 4 versus 4 versus 2% () | [33] |
|
| NeoSphere | II (417) | HER2+, ≥2 cm or cT4d | (A) 4 × Doc + H versus
(B) 4 × Doc + H + P versus
(C) H + P versus
(D) 4 × Doc + P | pCR 29 versus 46 versus 17 versus 24%
(B versus A: ;
C versus A: ;
B versus D: ) | cORR 81 versus 88 versus 66 versus 74% | [35] |
|
| TRYPHAENA | II (225) | HER2+, II-III | 3 × FEC + H + P → 3 × Doc + H + P versus
3 × FEC → 3 × Doc + H + P versus 6 × Doc + Carbo + H + P | Cardiac safety: symptomatic LVSD 0 versus 2.7 versus 0% | pCR 62 versus 57 versus 66%;
cORR 92 versus 95 versus 90% | [36] |
|
