Table 1.
Patient demographics and disease characteristics at baseline (Safety Population).
| Characteristic | SG (n = 258) | TPC (n = 224) |
|---|---|---|
| Female, n (%) | 256 (99) | 224 (100) |
| Age | ||
| Median, years (range) | 54 (27–82) | 54 (30–81) |
| <50 years, n (%) | 92 (36) | 71 (32) |
| 50–64 years, n (%) | 117 (45) | 105 (47) |
| ≥65 years, n (%) | 49 (19) | 48 (21) |
| ECOG PS, n (%) | ||
| 0 | 117 (45) | 93 (42) |
| 1 | 141 (55) | 131 (58) |
| Race or ethnic group, n (%) | ||
| White | 211 (82) | 172 (77) |
| Black | 25 (10) | 31 (14) |
| Asian | 11 (4) | 9 (4) |
| Other | 11 (4) | 12 (5) |
| Brain metastasis at randomization, n (%) | ||
| Yes | 30 (12) | 23 (10) |
| No | 228 (88) | 201 (90) |
| Median no. prior anticancer regimens1, (range) | 4 (2–17) | 4 (2–14) |
| Prior chemotherapy regimens from randomization stratification, n (%) | ||
| 2–3 | 178 (69) | 158 (71) |
| >3 | 80 (31) | 66 (29) |
| BRCA1/2 mutation status2, n (%) | ||
| Negative | 145 (56) | 123 (55) |
| Positive | 19 (7) | 20 (9) |
| Unknown | 94 (36) | 81 (36) |
| UGT1A1 variant status3, n (%) | ||
| *1/*1 (wild type) | 113 (44) | NA |
| *1/*28 (heterozygous) | 96 (37) | NA |
| *28/*28 (homozygous) | 34 (13) | NA |
| Unknown/other | 15 (6) | NA |
| Original diagnosis of TNBC4, n (%) | ||
| Yes | 184 (71) | 156 (70) |
| No | 74 (29) | 68 (30) |
| Median time from metastatic diagnosis, mo. (range) | 17.1 (0.1–202.9) | 15.5 (−0.4–95.8) |
Assessed in the safety population.
BRCA breast cancer gene, ECOG PS Eastern Cooperative Oncology Group performance status, NA not applicable, SG sacituzumab govitecan, TNBC triple-negative breast cancer, TPC treatment of physician’s choice, UGT uridine diphosphate glucuronosyltransferase.
1Anticancer regimens refer to any prior metastatic/neoadjuvant/adjuvant/locally advanced regimens used to treat an eligible breast cancer patient, including hormonal treatment.
2Approximately 64% of patients in each arm consented and had known BRCA1/2 mutation status.
3Population of patients with known UGT1A1 variant status was 250.
4Patients on study either had TNBC at initial diagnosis or had hormone receptor-positive disease that converted to hormone-negative at time of study entry.