Table 1.

Patient demographics and baseline characteristics

ParameterDose 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
 07 (47%)14 (78%)21 (64%)
 18 (53%)4 (22%)12 (36%)
Menopausal status, n (%)
 Premenopausal or perimenopausal2 (13%)1 (6%)3 (9%)
 Postmenopausal13 (87%)17 (94%)30 (91%)
Histology
 Invasive ductal carcinoma/no special type10 (67%)15 (83%)25 (76%)
 Invasive lobular carcinoma4 (27%)1 (6%)5 (15%)
 Others or not specified1 (7%)2 (11%)3 (9%)
Receptor statusa
 ER
  Strong12 (80%)17 (94%)29 (88%)
  Moderate3 (20%)1 (6%)4 (12%)
  Weak0 (0%)0 (0%)0 (0%)
 PgR
  Strong11 (73%)8 (44%)19 (58%)
  Moderate1 (7%)3 (17%)4 (12%)
  Weak2 (13%)3 (17%)5 (15%)
  Negative1 (7%)4 (22%)5 (15%)
 BCL2
  Strong11 (73%)17 (94%)28 (85%)
  Moderate4 (27%)1 (6%)5 (15%)
  Weak0 (0%)0 (0%)0 (0%)
 Median Ki67 % (range)10% (1–30)30% (5–60)15% (1–60)
Sites of disease
 Bone14 (93%)12 (67%)26 (79%)
 Visceral metastases9 (60%)11 (61%)20 (61%)
 Liver3 (20%)8 (44%)11 (33%)
 Lung7 (47%)5 (28%)12 (36%)
 Nodal7 (47%)9 (50%)16 (48%)
Adjuvant endocrine therapy (%)
 Tamoxifen only6 (40%)5 (28%)11 (33%)
 Aromatase inhibitor only2 (13%)4 (22%)6 (18%)
 Tamoxifen and aromatase inhibitor1 (7%)5 (28%)6 (18%)
 Other (toremefine)1 (7%)0 (0%)1 (3%)
 None5 (33%)4 (22%)9 (27%)
Prior lines of metastatic therapy, n (%)
 03 (20%)8 (44%)11 (33%)
 13 (20%)4 (22%)7 (21%)
 ≥29 (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 (%)
 None5 (33%)7 (39%)12 (36%)
 Adjuvant setting only4 (27%)9 (50%)13 (39%)
 Metastatic setting only3 (20%)1 (6%)4 (12%)
 Adjuvant and metastatic3 (20%)1 (6%)4 (12%)
Prior disease progression on tamoxifen
 Yes6 (40%)3 (17%)9 (27%)
 No9 (60%)15 (83%)24 (73%)
Prior chemotherapy exposure (%)
 None5 (33%)7 (39%)12 (36%)
 Adjuvant setting only4 (27%)5 (28%)9 (27%)
 Metastatic setting only3 (20%)2 (11%)5 (15%)
 Adjuvant and metastatic3 (20%)4 (22%)7 (21%)
  • Abbreviation: ECOG, Eastern Cooperative Oncology Group.aSixteen patients were enrolled based on results of archival tissue.