Phase 1 trial of entinostat as monotherapy and combined with exemestane in Japanese patients with hormone receptor-positive advanced breast cancer

Table 1 Demographic and other baseline characteristics

Characteristic	Total	Cohort 1 ENT 3 mg mono → EXE combo	Cohort 2 ENT 5 mg mono → EXE combo	Cohort 3 ENT 10 mg mono → EXE combo	Cohort 4 ENT 5 mg + EXE combo
N	12	3	3	3	3
Age, median (range), years	61.5 (48–72)	56.0 (48–62)	61.0 (59–62)	64.0 (55–65)	68.0 (55–72)
Baseline BMI, mean (SD), kg/m²	22.82 (3.25)	24.00 (4.30)	22.53 (4.73)	22.33 (3.08)	22.40 (2.19)
Baseline ECOG PS
0	11 (91.7)	3 (100.0)	2 (66.7)	3 (100.0)	3 (100.0)
1	1 (8.3)	0	1 (33.3)	0	0
Histopathological description
Invasive ductal carcinoma	10 (83.3)	3 (100.0)	3 (100.0)	3 (100.0)	1 (33.3)
Other	2 (16.7)	0	0	0	2 (66.7)
ER+/PgR+	10 (83.3)	2 (66.7)	3 (100.0)	3 (100.0)	2 (66.7)
ER+/PgR−	1 (8.3)	0	0	0	1 (33.3)
ER−/PgR+	1 (8.3)	1 (33.3)	0	0	0
Current metastatic site	12 (100.0)	3 (100.0)	3 (100.0)	3 (100.0)	3 (100.0)
Visceral disease (lung, liver metastasis)	7 (58.3)	2 (66.7)	2 (66.7)	2 (66.7)	1 (33.3)
Prior surgery	11 (91.7)	3 (100.0)	3 (100.0)	2 (66.7)	3 (100.0)
Prior systemic therapy^a	11 (91.7)	2 (66.7)	3 (100.0)	3 (100.0)	3 (100.0)
Prior chemotherapy^a
0	8 (66.7)	2 (66.7)	3 (100.0)	2 (66.7)	1 (33.3)
1	2 (16.7)	1 (33.3)	0	1 (33.3)	0
2	2 (16.7)	0	0	0	2 (66.7)
Prior endocrine therapy^a
0	1 (8.3)	1 (33.3)	0	0	0
1	3 (25.0)	1 (33.3)	1 (33.3)	1 (33.3)	0
2	3 (25.0)	0	1 (33.3)	1 (33.3)	1 (33.3)
≥ 3	5 (41.7)	1 (33.3)	1 (33.3)	1 (33.3)	2 (66.7)

All values are n (%), unless otherwise stated
BMI Body mass index, ECOG PS Eastern Cooperative Oncology Group performance status, ENT Entinostat, ER+/− estrogen receptor-positive/negative, EXE Exemestane, PgR+/− Progesterone receptor-positive/negative, S.D. Standard deviation
^aFor advanced or metastatic breast cancer

ISSN: 1471-2407