Patient demographics and baseline characteristics
Parameter | Dose escalation n = 15 (%) | Dose expansion n = 18 (%) | Overall n = 33 (%) | ||
---|---|---|---|---|---|
Median age (range) | 65 (45–78) | 66 (43–75) | 65 (43–78) | ||
ECOG performance status | |||||
0 | 7 (47%) | 14 (78%) | 21 (64%) | ||
1 | 8 (53%) | 4 (22%) | 12 (36%) | ||
Menopausal status, n (%) | |||||
Premenopausal or perimenopausal | 2 (13%) | 1 (6%) | 3 (9%) | ||
Postmenopausal | 13 (87%) | 17 (94%) | 30 (91%) | ||
Histology | |||||
Invasive ductal carcinoma/no special type | 10 (67%) | 15 (83%) | 25 (76%) | ||
Invasive lobular carcinoma | 4 (27%) | 1 (6%) | 5 (15%) | ||
Others or not specified | 1 (7%) | 2 (11%) | 3 (9%) | ||
Receptor statusa | |||||
ER | |||||
Strong | 12 (80%) | 17 (94%) | 29 (88%) | ||
Moderate | 3 (20%) | 1 (6%) | 4 (12%) | ||
Weak | 0 (0%) | 0 (0%) | 0 (0%) | ||
PgR | |||||
Strong | 11 (73%) | 8 (44%) | 19 (58%) | ||
Moderate | 1 (7%) | 3 (17%) | 4 (12%) | ||
Weak | 2 (13%) | 3 (17%) | 5 (15%) | ||
Negative | 1 (7%) | 4 (22%) | 5 (15%) | ||
BCL2 | |||||
Strong | 11 (73%) | 17 (94%) | 28 (85%) | ||
Moderate | 4 (27%) | 1 (6%) | 5 (15%) | ||
Weak | 0 (0%) | 0 (0%) | 0 (0%) | ||
Median Ki67 % (range) | 10% (1–30) | 30% (5–60) | 15% (1–60) | ||
Sites of disease | |||||
Bone | 14 (93%) | 12 (67%) | 26 (79%) | ||
Visceral metastases | 9 (60%) | 11 (61%) | 20 (61%) | ||
Liver | 3 (20%) | 8 (44%) | 11 (33%) | ||
Lung | 7 (47%) | 5 (28%) | 12 (36%) | ||
Nodal | 7 (47%) | 9 (50%) | 16 (48%) | ||
Adjuvant endocrine therapy (%) | |||||
Tamoxifen only | 6 (40%) | 5 (28%) | 11 (33%) | ||
Aromatase inhibitor only | 2 (13%) | 4 (22%) | 6 (18%) | ||
Tamoxifen and aromatase inhibitor | 1 (7%) | 5 (28%) | 6 (18%) | ||
Other (toremefine) | 1 (7%) | 0 (0%) | 1 (3%) | ||
None | 5 (33%) | 4 (22%) | 9 (27%) | ||
Prior lines of metastatic therapy, n (%) | |||||
0 | 3 (20%) | 8 (44%) | 11 (33%) | ||
1 | 3 (20%) | 4 (22%) | 7 (21%) | ||
≥2 | 9 (60%) | 6 (33%) | 15 (45%) | ||
Mean prior lines of treatment (range) | 2.7 (0–6) | 1.5 (0–8) | 2.0 (0–8) | ||
Prior tamoxifen exposure (%) | |||||
None | 5 (33%) | 7 (39%) | 12 (36%) | ||
Adjuvant setting only | 4 (27%) | 9 (50%) | 13 (39%) | ||
Metastatic setting only | 3 (20%) | 1 (6%) | 4 (12%) | ||
Adjuvant and metastatic | 3 (20%) | 1 (6%) | 4 (12%) | ||
Prior disease progression on tamoxifen | |||||
Yes | 6 (40%) | 3 (17%) | 9 (27%) | ||
No | 9 (60%) | 15 (83%) | 24 (73%) | ||
Prior chemotherapy exposure (%) | |||||
None | 5 (33%) | 7 (39%) | 12 (36%) | ||
Adjuvant setting only | 4 (27%) | 5 (28%) | 9 (27%) | ||
Metastatic setting only | 3 (20%) | 2 (11%) | 5 (15%) | ||
Adjuvant and metastatic | 3 (20%) | 4 (22%) | 7 (21%) |
↵Abbreviation: ECOG, Eastern Cooperative Oncology Group.aSixteen patients were enrolled based on results of archival tissue.