Table 1 Patient demographic and baseline clinical characteristics (full analysis set).

From: QL1209 (pertuzumab biosimilar) versus reference pertuzumab plus trastuzumab and docetaxel in neoadjuvant treatment for HER2-positive, ER/PR-negative, early or locally advanced breast cancer: A multicenter, randomized, double-blinded, parallel-controlled, phase III equivalence trial

 

QL1209 (N = 257)

Reference pertuzumab (N = 259)

Age, years; median (range)

53 (24–71)

53 (25–74)

Gender, n (%)

  Male

0

0

  Female

257 (100)

259 (100)

Race, n (%)

  Han

244 (94.9)

243 (93.8)

  Other

13 (5.1)

16 (6.2)

BMI, kg/m2; median (range)

24.22 (17.6–33.6)

24.33 (17.0–37.5)

Breast cancer type, n (%)

  Early

161 (62.6)

165 (63.7)

  Locally advanced

96 (37.4)

94 (36.3)

Clinical TNM stage

  II

134 (52.1)

140 (54.)

  III

111 (43.2)

115 (44.4)

  Other

12 (4.7)

4 (1.5)

Lymph node status

  Yes

193 (75.1)

193 (74.5)

  No

64 (24.9)

66 (25.5)

Previous anti-tumor therapies, n (%)

1 (0.4)

0

LVEF, %; median (range)

65 (55-81)

66 (53-78.8)

  1. BMI Body Mass Index, LVEF left ventricular ejection fraction.