Table 1. Patient Characteristics.
| Characteristic | No. (%) | |
|---|---|---|
| Arm 1: alisertib (n = 46) | Arm 2: alisertib + fulvestrant (n = 45) | |
| Age, y | ||
| 18-39 | 3 (6.5) | 4 (8.9) |
| 40-59 | 14 (30.4) | 20 (44.4) |
| 60-74 | 25 (54.4) | 19 (42.2) |
| ≥75 | 4 (8.7) | 2 (4.4) |
| Race | ||
| American Indian/Alaskan Native | 0 | 1 (2.2) |
| Asian | 2 (4.4) | 0 |
| Black/African American | 3 (6.5) | 3 (6.7) |
| White | 40 (87.0) | 39 (86.7) |
| Not reported | 1 (2.2) | 2 (4.4) |
| Hispanic ethnicity | 1 (2.2) | 4 (8.9) |
| BMI | ||
| Underweight | 0 | 1 (2.2) |
| Normal | 14 (30.4) | 21 (46.7) |
| Overweight | 13 (28.3) | 15 (33.3) |
| Obesity | 19 (41.3) | 8 (17.8) |
| ECOG performance status | ||
| 0 | 30 (65.2) | 27 (60.0) |
| 1 | 16 (34.8) | 18 (40.0) |
| Any prior chemotherapy | ||
| (Neo)adjuvant setting | 27 (58.7) | 27 (60.0) |
| Metastatic setting | 22 (47.8) | 31 (68.9) |
| Prior lines of chemotherapy in MBC | ||
| 0 | 24 (52.1) | 14 (31.1) |
| 1 | 9 (19.6) | 19 (42.2) |
| 2 | 13 (28.3) | 12 (26.7) |
| Any prior endocrine therapy | ||
| (Neo)adjuvant setting | 31 (67.4) | 29 (64.4) |
| Metastatic setting | 46 (100) | 45 (100) |
| Prior (neo)adjuvant endocrine therapy | ||
| Anastrozole | 16 (34.8) | 15 (33.3) |
| Exemestane | 4 (8.7) | 5 (11.1) |
| Fulvestrant | 7 (15.2) | 2 (4.4) |
| Letrozole | 10 (21.7) | 6 (13.3) |
| Raloxifene | 1 (2.2) | 0 |
| Tamoxifen | 15 (32.6) | 22 (48.9) |
| Prior MBC endocrine therapy | ||
| Amcenestrant | 1 (2.2) | 0 |
| Anastrozole | 8 (17.4) | 4 (8.9) |
| Exemestane | 16 (34.8) | 26 (57.8) |
| Fulvestrant | 45 (97.8) | 45 (100) |
| Letrozole | 21 (45.7) | 33 (73.3) |
| Tamoxifen | 12 (26.1) | 10 (22.2) |
| Prior CDK 4/6 inhibitor treatment | 46 (100) | 45 (100) |
| Prior everolimus treatment | ||
| Yes | 17 (37.0) | 26 (57.8) |
| No | 29 (63.0) | 19 (42.2) |
| Endocrine resistance | ||
| Primary | 11 (23.9) | 8 (17.8) |
| Secondary | 35 (76.1) | 37 (82.2) |
| Metastatic sites of disease | ||
| Nonvisceral | 14 (31.1) | 10 (22.2) |
| Visceral | 31 (68.9) | 35 (77.8) |
| Metastatic tumor ERα expression | ||
| Positive (≥10%) | 32 (69.6) | 31 (68.9) |
| Borderline (1%-9.9%) | 3 (6.5) | 4 (13.1) |
| Negative | 5 (10.9) | 3 (6.7) |
| Insufficient tissue | 6 (13.0) | 7 (15.6) |
Abbreviations: BMI, body mass index (calculated as weight in kilograms divided by height in meters squared); CDK, cyclin-dependent kinase; ER, estrogen receptor; MBC, metastatic breast cancer.