Table 1 Baseline demographic and disease characteristicsa.
Characteristic | ITT population (N = 40) |
|---|---|
Median age, years (range) | 48 (34–69) |
Females, n (%) | 40 (100.0) |
Race, n (%) | |
White | 36 (90.0) |
Asian | 2 (5.0) |
Other | 1 (2.5) |
Not reported | 1 (2.5) |
ECOG PS, n (%) | n = 39 |
0 | 13 (33.3) |
1 | 26 (66.7) |
Median LVEF, % (range) | n = 39 |
60 (50–75) | |
Breast cancer stage at initial diagnosis, n (%) | |
0 | 1 (2.5) |
I | 2 (5.0) |
II | 9 (22.5) |
III | 10 (25.0) |
IV | 18 (45.0) |
Patients with extracranial disease, n (%) | 24 (60.0) |
Measurable | 8 (20.0) |
Non-measurable | 16 (40.0) |
Prior CNS radiotherapy, n (%) | n = 39 |
WBRT only | 16 (41.0) |
SRS only | 11 (28.2) |
Both WBRT and SRS | 12 (30.8) |
Prior craniotomy, n (%) | 6 (15.0) |
Prior HER2-targeted treatment for MBC, n (%)a | |
Trastuzumab plus pertuzumab | 19 (47.5) |
Trastuzumab only | 15 (37.5) |
T-DM1 | 15 (37.5) |
Lapatinib | 18 (45.0) |
Neratinib | 3 (7.5) |
Median number of prior chemotherapy agents, n (range) | n = 17 |
3 (2–5) | |
Concomitant on-study systemic treatment for MBC, n (%)a,b | n = 11 |
Anastrozole | 1 (9.1) |
Capecitabine | 3 (27.3) |
Exemestane | 1 (9.1) |
Fulvestrant | 1 (9.1) |
Gemcitabine | 1 (9.1) |
Letrozole | 2 (18.2) |
Palbociclib | 3 (27.3) |
Vinorelbine | 1 (9.1) |
Concomitant antiepileptics use during study, n (%)a | n = 29 |
Acetazolamide | 1 (3.4) |
Cannabis | 3 (10.3) |
Clonazepam | 1 (3.4) |
Diazepam | 2 (6.9) |
Gabapentin | 9 (31.0) |
Lacosamide | 3 (10.3) |
Levetiracetam | 17 (58.6) |
Lorazepam | 14 (48.3) |
Midazolam | 1 (3.4) |
Topiramate | 1 (3.4) |
Zonisamide | 1 (3.4) |
Concomitant corticosteroid use during study, n (%) | |
No | 29 (72.5) |
Yes | 11 (27.5) |
Dexamethasonea,b | 11 (100.0) |
Othera,b | 1 (9.1) |
Median time from onset of brain metastases to first dose of study treatment, months (range) | 19.4 (3.1–65.5) |
