Table 1.
Characteristic | NeoALTTO (n = 455) | ALTTO (n = 8,381) |
---|---|---|
Primary end point | Breast pCR | DFS |
Approach to dual HER2 blockade | Lapatinib plus trastuzumab | Lapatinib plus trastuzumab, or trastuzumab then lapatinib |
Menopausal status | NA | Postmenopausal or male: 56–57% (0–0.25% male) Premenopausal: 43–44% |
Tumour size* | ≤ 2cm: 1.3–2.6% >2cm and ≤5: 44.3–61.8% >5 cm: 35.5–53% Missing or NA: 0–1.3% |
≤ 2cm: 41% >2cm and ≤5: 44–45% >5 cm: 5–6% Missing or NA: 9–10% |
Axillary-lymph-node status* | N0–1: 83.8–84.6% ≥N2, Nx, or missing: 15.4–16.2% |
N0: 40% N1–3: 29–30% ≥N4: 22% Missing or NA: 8–9% |
ER status* | ER negative: 48.1–49.7% ER positive: 50.3–51.9% |
ER negative: 42–43% ER positive: 57–58% |
Ranges represent the different values across treatment arms.
DFS, disease-free survival; ER, oestrogen receptor; N, regional lymph node stage; NA, not available; Nx, regional lymph nodes could not be assessed (for example, previously removed); pCR, pathological complete response.