Table 1.
Baseline demographic and disease characteristics of patients (FAS)
| Variable | Treatment group | Total (n = 167) n (%) |
|
|---|---|---|---|
| TAP-144-SR (6M) (n = 83) n (%) |
TAP-144-SR (3M) (n = 84) n (%) |
||
| Age (years) | |||
| ≤39 | 13 (15.7) | 12 (14.3) | 25 (15.0) |
| 40–44 | 29 (34.9) | 30 (35.7) | 59 (35.3) |
| ≥45 | 41 (49.4) | 42 (50.0) | 83 (49.7) |
| Mean ± SD | 44.2 ± 4.9 | 44.0 ± 5.2 | 44.1 ± 5.0 |
| BMI (kg/m2) | |||
| Mean ± SD | 21.5 ± 3.0 | 21.5 ± 2.9 | 21.5 ± 3.0 |
| Tumor stage (TNM classification) | |||
| I | 61 (73.5) | 61 (72.6) | 122 (73.1) |
| IIA | 19 (22.9) | 21 (25.0) | 40 (24.0) |
| IIB | 2 (2.4) | 2 (2.4) | 4 (2.4) |
| IIIA | 1 (1.2) | 0 (0.0) | 1 (0.6) |
| Tumor size (cm) | |||
| ≤2.0 | 65 (78.3) | 66 (78.6) | 131 (78.4) |
| >2.0 | 18 (21.7) | 18 (21.4) | 36 (21.6) |
| Number of positive axillary lymph nodes | |||
| 0 | 68 (81.9) | 70 (83.3) | 138 (82.6) |
| 1–3 | 15 (18.1) | 14 (16.7) | 29 (17.4) |
| ER/PgR expression | |||
| ER+/PgR+ | 82 (98.8) | 82 (97.6) | 164 (98.2) |
| ER+/PgR− | 1 (1.2) | 2 (2.4) | 3 (1.8) |
| ER−/PgR+ | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Radiation therapy | |||
| Presence | 52 (62.7) | 59 (70.2) | 111 (66.5) |
| Absence | 31 (37.3) | 25 (29.8) | 56 (33.5) |
| Pre- and postoperative chemotherapy | |||
| Presence | 0 (0.0) | 1 (1.2) | 1 (0.6) |
| Absence | 83 (100.0) | 83 (98.8) | 166 (99.4) |
| Serum estradiol (pg/mL) at Week 0 | |||
| Mean ± SD | 168.0 ± 163.0 | 138.2 ± 125.5 | 153.0 ± 145.7 |
FAS full analysis set, BMI body mass index, SD standard deviation, ER estrogen receptor, PgR progesterone receptor