Skip to main content

Table 1 Demographic and baseline characteristics

From: Phase 1b/2a study of trastuzumab emtansine (T-DM1), paclitaxel, and pertuzumab in HER2-positive metastatic breast cancer

Characteristic Phase 1b Phase 2a
All patients (N = 60) Group A (n = 22) Group B (n = 22) All patients (N = 44)
Median age, years (range) 53.5 (23–77) 50.0 (35–81) 54.0 (43–72) 52.5 (35–81)
Gender, n (%)     
 Female 58 (97) 21 (95.5) 22 (100) 43 (97.7)
 Male 2 (3) 1 (4.5) 0 1 (2.3)
Race, n (%)     
 White 55 (92) 16 (72.7) 20 (90.9) 36 (81.8)
 Asian 3 (5) 2 (9.1) 0 2 (4.5)
 Black 1 (2) 3 (13.6) 1 (4.5) 4 (9.1)
 Not available 1 (2) 1 (4.5) 1 (4.5) 2 (4.5)
ECOG performance status, n (%)     
 0 28 (47) 12 (54.5) 14 (63.6) 26 (59.1)
 1 29 (48) 8 (36.4) 7 (31.8) 15 (34.1)
 2 3 (5) 2 (9.1) 1 (4.5) 3 (6.8)
Hormone status, n (%)     
 ER+ and/or PR+ 43 (61) 10 (45.5) 13 (59.1) 23 (52.3)
 ER- and PR– 16 (27) 12 (54.5)a 9 (40.9) 21 (47.7)
 Unknown 1 (2) 0 0 0
Prior radiotherapy, n (%) 47 (78) 17 (77.3) 17 (77.3) 34 (77.3)
Prior surgery, n (%) 60 (100) 22 (100) 22 (100) 44 (100)
Prior systemic therapies, n (%) 60 (100) 22 (100) 22 (100) 44 (100)
 Trastuzumab 60 (100) 22 (100) 21 (95.5) 43 (97.7)
 Chemotherapy 60 (100) 22 (100) 22 (100) 44 (100)
 Anthracycline 47 (78) 13 (59.1) 17 (77.3) 30 (68.2)
 Taxane 54 (90) 20 (90.9) 16 (72.7) 36 (81.8)
 Lapatinib 48 (80) 15 (68.2) 14 (63.6) 29 (65.9)
 Hormonal 39 (65) 12 (54.5)a 13 (59.1) 25 (56.8)a
 Experimental   7 (31.8) 5 (22.7) 12 (27.3)
 Other biologic   3 (13.6) 1 (4.5) 4 (9.1)
Number of prior systemic agents, median (range)b 8.5 (2–21) 7.5 (2–12) 6.5 (3–14) 7.0 (2–14)
Number of prior systemic agents in the metastatic setting, median (range)b 6.5 (0–18) 6.0 (1–9) 5.0 (0–10) 5.0 (0–10)c
Median time since metastatic diagnosis, months (range) 37.9 (4–111) 46.9 (11–199) 48.1 (1–170) 46.9 (1–199)
  1. ECOG Eastern Cooperative Oncology Group, ER estrogen receptor, PR progesterone receptor
  2. aTwo patients with hormone receptor-negative disease received prior hormonal therapy
  3. bDoes not include hormonal therapy
  4. cOne patient did not receive any prior systemic agents in the metastatic setting