Table 1.
Demographics and baseline characteristics of the intention-to-treat population.
| Giredestrant 10 mg | Giredestrant 30 mg | Giredestrant 90/100 mg ± LHRH | Giredestrant 250 mg ± LHRH | All giredestrant doses | Giredestrant 100 mg + palbociclib 125 mg ± LHRH | All patients | |
|---|---|---|---|---|---|---|---|
| (n = 6) | (n = 41) | (n = 55) | (n = 9) | (n = 111) | (n = 64) | (N = 175) | |
| Age, mean years (standard deviation) | 58.7 (10.6) | 60.1 (11.4) | 57.6 (10.8) | 57.4 (11.2) | 58.6 (11.0) | 56.9 (10.9) | 58.0 (10.9) |
| Ethnicity | |||||||
| Hispanic/Latino | 0 | 2 (4.9%) | 2 (3.6%) | 0 | 4 (3.6%) | 1 (1.6%) | 5 (2.9%) |
| Not Hispanic/Latino | 5 (83.3%) | 37 (90.2%) | 49 (89.1%) | 8 (88.9%) | 99 (89.2%) | 62 (96.9%) | 161 (92.0%) |
| Not stated | 1 (16.7%) | 2 (4.9%) | 0 | 0 | 3 (2.7%) | 0 | 3 (1.7%) |
| Unknown | 0 | 0 | 4 (7.3%) | 1 (11.1%) | 5 (4.5%) | 1 (1.6%) | 6 (3.4%) |
| Race | |||||||
| American Indian/ | 0 | 0 | 1 (1.8%) | 0 | 1 (0.9%) | 0 | 1 (0.6%) |
| Alaska Native | |||||||
| Asian | 0 | 12 (29.3%) | 13 (23.6%) | 4 (44.4%) | 29 (26.1%) | 11 (17.2%) | 40 (22.9%) |
| White | 6 (100%) | 28 (68.3%) | 37 (67.3%) | 4 (44.4%) | 75 (67.6%) | 53 (82.8%) | 128 (73.1%) |
| Unknown | 0 | 1 (2.4%) | 4 (7.3%) | 1 (11.1%) | 6 (5.4%) | 0 | 6 (3.4%) |
| Mean weight at baseline (kg; standard deviation) | 62.87 (8.64) | 69.94 (16.79) | 65.37 (15.60) | 65.60 (18.57) | 66.99 (16.01) | 67.86 (14.43) | 67.31 (15.41) |
| ECOG performance status score at baseline | |||||||
| 0 | 4 (66.7%) | 24 (58.5%) | 37 (67.3%) | 6 (66.7%) | 71 (64.0%) | 39 (60.9%) | 110 (62.9%) |
| 1 | 2 (33.3%) | 17 (41.5%) | 18 (32.7%) | 3 (33.3%) | 40 (36.0%) | 25 (39.1%) | 65 (37.1%) |
| Bone-only disease at baseline | |||||||
| Yes | 1 (16.7%) | 6 (14.6%) | 12 (21.8%) | 1 (11.1%) | 20 (18.0%) | 11 (17.2%) | 31 (17.7%) |
| No | 5 (83.3%) | 35 (85.4%) | 43 (78.2%) | 8 (88.9%) | 91 (82.0%) | 53 (82.8%) | 144 (82.3%) |
| Visceral disease at baseline | |||||||
| Yes | 3 (50.0%) | 30 (73.2%) | 35 (63.6%) | 4 (44.4%) | 72 (64.9%) | 45 (70.3%) | 117 (66.9%) |
| No | 3 (50.0%) | 11 (26.8%) | 20 (36.4%) | 5 (55.6%) | 39 (35.1%) | 19 (29.7%) | 58 (33.1%) |
| Measurable disease at baseline | |||||||
| Yes | 4 (66.7%) | 30 (73.2%) | 41 (74.5%) | 6 (66.7%) | 81 (73.0%) | 56 (87.5%) | 137 (78.3%) |
| No | 2 (33.3%) | 11 (26.8%) | 14 (25.5%) | 3 (33.3%) | 30 (27.0%) | 8 (12.5%) | 38 (21.7%) |
| Number of lines of prior metastatic therapies, median (range) | 1.50 (0–3.0) | 1.00 (0–2.0) | 1.00 (0–2.0) | 1.00 (0–2.0) | 1.00 (0–3.0) | 1.00 (0–2.0) | 1.00 (0–3.0) |
| Prior use of fulvestrant | |||||||
| Yes | 2 (33.3%) | 8 (19.5%) | 13 (23.6%) | 0 | 23 (20.7%) | 5 (7.8%) | 28 (16.0%) |
| No | 4 (66.7%) | 33 (80.5%) | 42 (76.4%) | 9 (100%) | 88 (79.3%) | 59 (92.2%) | 147 (84.0%) |
| Prior use of CDK4/6i | |||||||
| Yes | 4 (66.7%) | 27 (66.9%) | 34 (61.8%) | 7 (77.8%) | 72 (64.9%) | 5 (7.8%)a | 77 (44.0%) |
| No | 2 (33.3%) | 14 (34.1%) | 21 (38.2%) | 2 (22.2%) | 39 (35.1%) | 59 (92.2%) | 98 (56.0%) |
| Baseline ESR1 mutation status | |||||||
| No mutation detected | 2 (33.3%) | 19 (46.3%) | 32 (58.2%) | 3 (33.3%) | 56 (50.5%) | 40 (62.5%) | 96 (54.9%) |
| Mutation detected | 4 (66.7%) | 21 (51.2%) | 21 (38.2%) | 6 (66.7%) | 52 (46.8%) | 18 (28.1%) | 70 (40.0%) |
| Unknown | 0 | 1 (2.4%) | 2 (3.6%) | 0 | 3 (2.7%) | 6 (9.4%) | 9 (5.1%) |
| Prior chemotherapy in the metastatic setting | |||||||
| Yes | 2 (33.3%) | 8 (19.5%) | 8 (14.5%) | 1 (11.1%) | 19 (17.1%) | 13 (20.3%) | 32 (18.3%) |
| No | 4 (66.7%) | 33 (80.5%) | 47 (85.5%) | 8 (88.9%) | 92 (82.9%) | 51 (79.7%) | 143 (81.7%) |
| Prior use of chemotherapyb | |||||||
| Yes | 5 (83.3%) | 20 (48.8%) | 36 (65.5%) | 7 (77.8%) | 68 (61.3%) | 53 (82.8%) | 121 (69.1%) |
| No | 1 (16.7%) | 21 (51.2%) | 19 (34.5%) | 2 (22.2%) | 43 (38.7%) | 11 (17.2%) | 54 (30.9%) |
| Histologic subtype | |||||||
| Ductal | 4 (66.7%) | 31 (77.5%) | 42 (80.8%) | 7 (77.8%) | 84 (78.5%) | 56 (88.9%) | 140 (82.4%) |
| Lobular | 2 (33.3%) | 6 (15.0%) | 10 (19.2%) | 2 (22.2%) | 20 (18.7%) | 7 (11.1%) | 27 (15.9%) |
| NOS | 0 | 2 (5.0%) | 0 | 0 | 2 (1.9%) | 0 | 2 (1.2%) |
| Other | 0 | 1 (2.5%) | 0 | 0 | 1 (0.9%) | 0 | 1 (0.6%) |
| Nuclear grade (pleomorphism) | |||||||
| Grade 1 | 0 | 3 (7.5%) | 5 (9.8%) | 0 | 8 (7.5%) | 2 (3.3%) | 10 (6.0%) |
| Grade 2 | 1 (16.7%) | 12 (30.0%) | 18 (35.3%) | 4 (44.4%) | 35 (33.0%) | 23 (37.7%) | 58 (34.7%) |
| Grade 3 | 2 (33.3%) | 10 (25.0%) | 9 (17.6%) | 2 (22.2%) | 23 (21.7%) | 20 (32.8%) | 43 (25.7%) |
| Unknown | 3 (50.0%) | 15 (37.5%) | 19 (37.3%) | 3 (33.3%) | 40 (37.7%) | 16 (26.2%) | 56 (33.5%) |
| Classification of breast cancer, distant metastasis at initial diagnosis | |||||||
| MX | 0 | 5 (12.2%) | 4 (7.5%) | 1 (11.1%) | 10 (9.3%) | 3 (4.8%) | 13 (7.6%) |
| M0 | 2 (50.0%) | 23 (56.1%) | 38 (71.7%) | 7 (77.8%) | 70 (65.4%) | 50 (79.4%) | 120 (70.6%) |
| M1 | 2 (50.0%) | 13 (31.7%) | 11 (20.8%) | 1 (11.1%) | 27 (25.2%) | 10 (15.9%) | 37 (21.8%) |
Note: Data are number of patients (%) unless specified.
Abbreviations: ECOG, Eastern Cooperative Oncology Group; NOS, not otherwise specified.
aPrior use of CDK4/6i was allowed in the cardiac evaluation cohort (5 patients within this cohort had received a prior CDK4/6i).
bPrior use of chemotherapy in any line of therapy.