Table 1 Baseline demographics (intent-to-treat population)a

From: Neoadjuvant PF-05280014 (a potential trastuzumab biosimilar) versus trastuzumab for operable HER2+ breast cancer

 

PF-05280014 (n = 114)

Trastuzumab-EU (n = 112)

Total (N = 226)

Age, mean (±SD), years

54.0 (11.9)

51.2 (12.7)

52.6 (12.3)

Race, n (%)

  White

112 (98.2)

109 (97.3)

221 (97.8)

  Black

1 (0.9)

0

1 (0.4)

  Asian

1 (0.9)

3 (2.7)

4 (1.8)

Ethnicity, n (%)

  Hispanic/Latino

0

1 (0.9)

1 (0.4)

  Not Hispanic/Latino

114 (100.0)

111 (99.1)

225 (99.6)

Mean body mass index (±SD), kg/m2

28.2 (5.9)

27.7 (6.2)

27.9 (6.1)

Primary tumour size, n (%)

  <5 cm

89 (78.1)

89 (79.5)

178 (78.8)

  ≥5 cm

25 (21.9)

23 (20.5)

48 (21.2)

Oestrogen receptor status, n (%)

  Positive

58 (50.9)

54 (48.2)

112 (49.6)

  Negative

56 (49.1)

58 (51.8)

114 (50.4)

Progesterone receptor status, n (%)

  Positive

41 (36.0)

40 (35.7)

81 (35.8)

  Negative

73 (64.0)

72 (64.3)

145 (64.2)

  1. aBaseline was defined as the value recorded at Day 1 Cycle 1. If this value was missing, the value recorded at screening was used.
  2. Trastuzumab-EU = licensed trastuzumab sourced from the European Union; SD = standard deviation