Study cohorts, stratified by PIK3CA mutation status | |||
---|---|---|---|
Full Sample | Mutated | Wild | |
N = 33 | N = 17 | N = 16 | |
Study and Patient characteristics | |||
Total number of patients | 3,219 | 1,386 | 1,833 |
PIK3CA Mutation Testing Methodology, N (%) | |||
ctDNA testing | 18 (54.5%) | 9 (52.9%) | 9 (56.3%) |
Tissue testing | 13 (39.4%) | 7 (41.2%) | 6 (37.5%) |
Missing | 2 (6.1%) | 1 (5.9%) | 1 (6.3%) |
Percentage of Patients with Prior Chemotherapy, median (range) | |||
Overallc | 67.0 (27.4, 95.4) | 64.6 (27.4, 92.0) | 72.0 (29.8, 95.4) |
For metastatic diseasec | 27.8 (0.0, 35.0) | 27.4 (0.0, 34.0) | 29.9 (0.0, 35.0) |
Median Follow-up Time (Months) | |||
Overall | 14.6 (7.4, 45.1) | 14.6 (8.9, 45.1) | 14.5 (7.4, 45.1) |
Study treatment | |||
Any Fulvestrant | 23 (69.7%) | 12 (70.6%) | 11 (68.8%) |
Abemaciclib + Fulvestrant | 2 (6.1%) | 1 (5.9%) | 1 (6.3%) |
Placebo + Fulvestrant | 19 (57.6%) | 10 (58.8%) | 9 (56.3%) |
Palbociclib + Fulvestrant | 2 (6.1%) | 1 (5.9%) | 1 (6.3%) |
Everolimus + Exemestane | 4 (12.1%) | 2 (11.8%) | 2 (12.5%) |
Placebo + Exemestane | 4 (12.1%) | 2 (11.8%) | 2 (12.5%) |
Other | 2 (6.1%) | 1 (5.9%) | 1 (6.3%) |
Survival outcomes | |||
Median progression-free survival (months) | 5.6 (1.4, 23.4) | 5.4 (1.4, 19.0) | 6.2 (1.7, 23.4) |
6 Month Survival Rate (%)e | 46.2 (10.8, 93.4) | 43.0 (10.8, 91.0) | 53.5 (19.8, 93.4) |
12 Month Survival Rate (%)e | 31.7 (5.8, 76.4) | 29.2 (18.8, 66.7) | 32.6 (5.8, 76.4) |
18 Month Survival Rate (%)e | 22.7 (3.2, 64.8) | 20.0 (18.4, 51.3) | 26.4 (3.2, 64.8) |
Median overall survival (months)d | 32.2 (19.6, 55.5) | 26.9 (19.6, 44.5) | 37.8 (23.5, 55.5) |