Table 1.
Patient baseline characteristics and disease characteristics
| All patients (N = 50)a | |
|---|---|
| Median age, years (range) | 52 (28–75) |
| Female patients, n (%) | 50 (100) |
| Postmenopausal status | 37 (74) |
| Race, n (%) | |
| Caucasian | 48 (96) |
| Others | 2 (4) |
| WHO performance status, n (%) | |
| 0 | 19 (38) |
| 1 | 31 (62) |
| Prior antineoplastic therapies, median (range) | |
| Prior antineoplastic regimensb | 3 (1–7) |
| Prior cytotoxic chemotherapies | 1 (0–3) |
| Prior HER2-targeted therapiesc | 2 (1–5) |
| Setting at last treatment, n (%) | |
| Therapeutic/palliative | 47 (94) |
| Adjuvant/neoadjuvant | 4 (8) |
| Therapy type at last treatment, n (%) | |
| HER2-targeted therapy | 40 (80) |
| Chemotherapy | 24 (48) |
| Hormonal therapy | 4 (8) |
| Other | 4 (8) |
| Hormonal status, n (%) | |
| ER and/or PgR positive | 27 (54) |
| ER and PgR negative | 23 (46) |
| Tumour histology, n (%) | |
| Invasive ductal carcinoma | 45 (90) |
| Invasive lobular carcinoma | 2 (4) |
| Other | 3 (6) |
| Histologic grade, n (%) | |
| Well differentiated | 0 |
| Moderately differentiated | 18 (36) |
| Poorly differentiated | 27 (54) |
| Unknown | 5 (10) |
| Number of metastatic sites, median (range) | 3 (1–6) |
| Most common site of metastases, n (%) | |
| Lung | 29 (58) |
| Bone | 26 (52) |
| Nodes | 26 (52) |
| Liver | 25 (50) |
| Brain | 6 (12) |
| Skin | 3 (6) |
| Others | 20 (40) |
| PI3 K pathway activation status in tumour tissue | |
| Patients with known status, n (%) | 26 (52) |
| PI3 K pathway-activatedd,e n/N (%) | 10/26 (38) |
| PI3 K pathway-non-activatede n/N (%) | 16/26 (62) |
ER oestrogen receptor, PgR progesterone receptor
a
Three patients received a loading dose of trastuzumab but not buparlisib, and are not included here
b
Includes HER2-targeted therapy, chemotherapy and hormonal therapy. All patients had received monoclonal antibodies (primarily trastuzumab) and 86% had received taxanes (primarily docetaxel)
c
Includes trastuzumab, T-DM1, lapatinib and pertuzumab
d
PI3 K pathway activation was defined as PIK3CA mutation (eight patients), PTEN mutation (one patient) or PTEN null or low expression by immunohistochemistry (H-score < 50; one patient)
e
Percentage calculated out of 26 patients with known PI3 K pathway activation status