Table 1 Baseline demographics and clinical characteristics
Characteristic | Part 1: pictilisib + paclitaxel ± bevacizumaba (n = 20) | Part 2A: pictilisib + paclitaxel (n = 18) | Part 2B: pictilisib + paclitaxel + bevacizumab (n = 15) | Part 2C: pictilisib + paclitaxel + trastuzumab (n = 9) | Part 3: pictilisib + letrozole (n = 7) | All patients (N = 69) |
|---|---|---|---|---|---|---|
Median age, years (range) | 54.0 (41–71) | 53.5 (30–76) | 49.0 (34–66) | 63.0 (42–68) | 59.0 (49–69) | 54.0 (30–76) |
ECOG PS, n (%) | ||||||
0 | 14 (70.0) | 6 (33.3) | 13 (86.7) | 5 (55.6) | 4 (57.1) | 42 (60.9) |
1 | 5 (25.0) | 12 (66.7) | 2 (13.3) | 4 (44.4) | 3 (42.9) | 26 (37.7) |
Unknown | 1 (5.0) | (0.0) | (0.0) | (0.0) | (0.0) | 1 (1.4) |
ER/PR status, n (%) | ||||||
Positive | 13 (65.0) | 11 (61.1) | 10 (66.7) | 8 (88.9) | 7 (100.0) | 49 (71.0) |
Negative | 7 (35.0) | 6 (33.3) | 5 (33.3) | 1 (11.1) | (0.0) | 19 (27.5) |
Unknown | (0.0) | 1 (5.6) | (0.0) | (0.0) | (0.0) | 1 (1.4) |
HER2 status, n (%) | ||||||
Positive | (0.0) | (0.0) | (0.0) | 9 (100.0) | (0.0) | 9 (13.0) |
Negative | 20 (100.00) | 18 (100.00) | 15 (100.00) | (0.00) | 7 (100.00) | 60 (87.00) |
Prior chemotherapy, n (%) | ||||||
Neoadjuvant | 6 (30.0) | 7 (38.9) | 5 (33.3) | 3 (33.3) | 1 (14.3) | 22 (31.9) |
Adjuvant setting | 12 (60.0) | 8 (44.4) | 7 (46.7) | 4 (44.4) | 4 (57.1) | 35 (50.7) |
Metastatic setting | 10 (50.0) | 9 (50.0) | 8 (53.3) | 8 (88.9) | (0.0) | 35 (50.7) |
Prior treatment, n (%) | ||||||
Taxanes | 10 (50.0) | 10 (55.6) | 8 (53.3) | 6 (66.7) | 3 (42.9) | 37 (53.6) |
Anti-HER2 therapies | 2 (10.0) | 1 (5.6) | (0.0) | 9 (100.0) | (0.0) | 12 (17.4) |
Bevacizumab | 1 (5.0) | 2 (11.1) | 1 (6.7) | (0.0) | 1 (14.3) | 5 (7.2) |
Line of therapy (metastatic setting) | ||||||
First | 3 (15.0) | 5 (27.8) | 1 (6.7) | (0.0) | 2 (28.6) | 11 (15.9) |
Second or laterb | 17 (85.0) | 13 (72.2) | 14 (93.3) | 9 (100.0) | 5 (71.4) | 58 (84.1) |