Table 3.

pCR rates in overall population and subgroups by definition of primary end-point and additional pCR definitions.

	Buparlisib+ trastuzumab + paclitaxel		Placebo +trastuzumab + paclitaxel		P-Valuea
	n	pCR, n (%) [95% CI]	n	pCR, n (%) [95% CI]
		ypT0/is		ypT0/is
All patients	25	8 (32.0) [14.9%–53.5%]	25	10 (40.0) [21.1%–61.3%]	0.811
PIK3CA status
PIK3CA WT	21	7 (33.3) [14.6%–57.0%]	21	9 (42.9) [21.8%–66.0%]	0.830
PIK3CA MT	4	1 (25.0) [0.6%–80.6%]	4	1 (25.0) [0.6%–80.6%]	0.786
ER status
ER+	16	5 (31.3) [11.0%–58.7%]	15	4 (26.7) [7.8%–55.1%]	0.546
ER−	9	3 (33.3) [7.5%–70.1%]	10	6 (60.0) [26.2%–87.8%]	0.949
		ypT0/is ypN0		ypT0/is ypN0
All patients	25	8 (32.0) [14.9%–53.5%]	25	9 (36.0) [18.0%, 57.5%]	0.724
ER status
ER+	16	5 (31.3) [11.0%–58.7%]	15	3 (20.0) [4.3%–48.1%]	0.382
ER−	9	3 (33.3) [7.5%–70.1%]	10	6 (60.0) [26.2%–87.8%]	0.949
		ypT0 ypN0		ypT0 ypN0
All patients	25	5 (20.0) [6.8%–40.7%]	25	7 (28.0) [12.1%–49.4%]	0.840
ER status
ER+	16	2 (12.5) [1.6%–38.3%]	15	2 (13.3) [1.7%–40.5%]	0.725
ER−	9	3 (33.3) [7.5%–70.1%]	10	5 (50.0) [18.7%, 81.3%]	0.885

CI, confidence interval; ER, oestrogen receptor; MT, mutant; pCR, pathological complete response; WT, wild-type.

^aOne-sided Fisher exact test.