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. Author manuscript; available in PMC: 2017 Sep 1.
Published in final edited form as: Nat Rev Clin Oncol. 2016 Mar 22;13(9):566–579. doi: 10.1038/nrclinonc.2016.35

Table 1.

Clinicopathological characteristics of the NeoALTTO and ALTTO trials

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.