Table 4.
Best overall response at week 6.
| Response at the end of biologic window | Buparlisib + trastuzumab + paclitaxel n (%) |
Placebo + trastuzumab + paclitaxel n (%) |
P-Valuea |
|---|---|---|---|
| All patients | n = 25 | n = 25 | |
| CR | 0 (0.0) | 1 (4.0) | |
| PR | 14 (56.0) | 10 (40.0) | |
| SD | 7 (28.0) | 9 (36.0) | |
| PD | 1 (4.0) | 3 (12.0) | |
| Missing | 3 (12.0) | 2 (8.0) | |
| ORR (CR or PR) | 14 (56.0) | 11 (44.0) | 0.286 |
| 95% CI for ORR | 34.9%–75.6% | 24.4%–65.1% | |
| PIK3CA status | |||
| PIK3CA WT | n = 21 | n = 21 | |
| CR | 0 (0.0) | 1 (4.8) | |
| PR | 13 (61.9) | 8 (38.1) | |
| SD | 5 (23.8) | 8 (38.1) | |
| PD | 1 (4.8) | 2 (9.5) | |
| Missing | 2 (9.5) | 2 (9.5) | |
| ORR (CR or PR) | 13 (61.9) | 9 (42.9) | 0.177 |
| 95% CI for ORR | 38.4%–81.9% | 21.8%–66.0% | |
| PIK3CA MT | n = 4 | n = 4 | |
| CR | 0 (0.0) | 0 (0.0) | |
| PR | 1 (25.0) | 2 (50.0) | |
| SD | 2 (50.0) | 1 (25.0) | |
| PD | 0 (0.0) | 1 (25.0) | |
| Missing | 1 (25.0) | 0 (0.0) | |
| ORR (CR or PR) | 1 (25.0) | 2 (50.0) | 0.929 |
| 95% CI for ORR | 0.6%–80.6% | 6.8%–93.2% | |
| ER status | |||
| ER+ | n = 16 | n = 15 | |
| ORR (CR or PR) | 11 (68.8) | 5 (33.3) | 0.053b |
| 95% CI for ORR | 41.3%–89.0% | 11.8%–61.6% | |
| ER− | n = 9 | n = 10 | |
| ORR (CR or PR) | 3 (33.3) | 6 (60.0) | 0.949 |
| 95% CI for ORR | 7.5%–70.1% | 26.2%–87.8% | |
CI, confidence interval; CR, complete response; ER, oestrogen receptor; MT, mutant; ORR, objective response rate; PD, progressive disease; PR, partial response; SD, stable disease; WT, wild-type.
a
One-sided Fisher exact test.
b
Significant interaction.