Cohort 1: pertuzumab, trastuzumab, and vinorelbine | ||||||
---|---|---|---|---|---|---|
All patients | History of prior trastuzumab therapy subgroups | Hormone receptor status subgroups | ||||
Prior trastuzumab therapy | No prior trastuzumab therapy | Estrogen receptor-positive and progesterone receptor-positive | Estrogen receptor-positive and progesterone receptor-negative | Estrogen receptor-negative and progesterone receptor-negative | ||
N = 106 | n = 44 | n = 62 | n = 45 | n = 25 | n = 36 | |
Best overall response | ||||||
Patients with measurable disease at baseline | 89 (84.0%) | 36 (81.8%) | 53 (85.5%) | 39 (86.7%) | 18 (72.0%) | 32 (88.9%) |
Overall response rate | 66 (74.2%) [63.8–82.9] | 28 (77.8%) [60.8–89.9] | 38 (71.7%) [57.7–83.2] | 27 (69.2%) [52.4–83.0] | 15 (83.3%) [58.6–96.4] | 24 (75.0%) [56.6–88.5] |
Complete response | 12 (13.5%) [7.2–22.4] | 6 (16.7%) [6.4–32.8] | 6 (11.3%) [4.3–23.0] | 6 (15.4%) [5.9–30.5] | 1 (5.6%) [0.1–27.3] | 5 (15.6%) [5.3–32.8] |
Partial response | 54 (60.7%) [49.7–70.9] | 22 (61.1%) [43.5–76.9] | 32 (60.4%) [46.0–73.5] | 21 (53.8%) [37.2–69.9] | 14 (77.8%) [52.4–93.6] | 19 (59.4%) [40.6–76.3] |
Stable disease | 16 (18.0%) [10.6–27.5] | 6 (16.7%) [6.4–32.8] | 10 (18.9%) [9.4–32.0] | 9 (23.1%) [11.1–39.3] | 3 (16.7%) [3.6–41.4] | 4 (12.5%) [3.5–29.0] |
Progressive disease | 5 (5.6%) [1.8–12.6] | 2 (5.6%) [0.7–18.7] | 3 (5.7%) [1.2–15.7] | 2 (5.1%) [0.6–17.3] | 0 [0.0–18.5] | 3 (9.4%) [2.0–25.0] |
Not evaluable | 2 (2.2%) [0.3–7.9] | 0 [0.0–9.7] | 2 (3.8%) [0.5–13.0] | 1 (2.6%) [0.1–13.5] | 0 [0.0–18.5] | 1 (3.1%) [0.1–16.2] |
Progression-free survival | ||||||
Median | 14.3 months [11.2–17.5] | 11.8 months [8.3–14.9] | 16.8 months [11.0–20.5] | 13.6 months [8.3–20.3] | 14.3 months [10.5–17.5] | 15.5 months [10.4–23.8] |
Number of patients with events | 74 (69.8%) | 36 (81.8%) | 38 (61.3%) | 32 (71.1%) | 18 (72.0%) | 24 (66.7%) |
Number of patients censored | 32 (30.2%) | 8 (18.2%) | 24 (38.7%) | 13 (28.9%) | 7 (28.0%) | 12 (33.3%) |