Table 3. Main characters of three phase III randomized controlled trials.
| Variables | TAILOR-X | MINDACT | Rx-PONDER |
|---|---|---|---|
| No. patients | 9,719 | 6,693 | 5,051 |
| Gene expression assay | Oncotype (21-gene) | MammaPrint (70-gene) | Oncotype (21-gene) |
| Eligible patients | HR+/HER2− | HR+/HER2− | HR+/HER2− |
| LN− | N0–1 (0–3 N+) | N1 (1–3 N+) | |
| Lymph node status | All LN− | LN−: n=5,288 (79%) | 1 N+: n=3,275 (65.3%) |
| 1–3 N+: n=1,405 (21%) | 2–3 N+: n=1,726 (34.4%) | ||
| Age or menopausal status | ≤50 years: n=3,052 (31.4%) | <50 years: n=2,226 (33.2%) | <50 years: n=1,224 (24.4%) |
| Premenopausal: n=3,330 (34%) | Premenopausal: n=1,665 (33.2%) | ||
| Primary end point | iDFS | DMFS | iDFS |
| ET alone non-inferior to CT + ET in RS 11−25 group | 5-year DMFS ≥92% in C-high/G-low without CT | Positive interaction between CT and the continuous RS score | |
| Randomization groups | RS [0−10]: ET (n=1,629, 17%) | C-low/G-low: ET alone (n=2,745, 41%) | RS [0–25]: randomized to ET alone vs. CT + ET |
| RS [11–25]: randomized to ET alone vs. CT + ET (n=6,711, 69%) | C-high/G-low (n=1,550, 23%) & C-low/G-high (n=592, 9%): randomized to ET alone vs. CT + ET | ||
| RS [≥26]: CT (n=1,389, 14%) | C-high/G-high: CT + ET | ||
| Result | iDFS hazard ratio 1.08 (95% CI: 0.94–1.24), P=0.26 | 5-year DMFS 94.7% (95% CI: 92.5–96.2%) | Interaction between CT and RS, hazard ratio 1.02 (95% CI: 0.98–1.05), P=0.35 |
CT, chemotherapy; ET, endocrine therapy; C/G, clinical/genomic-risk; LN, lymph node; iDFS, invasive disease-free survival; DMFS, distant metastatic free survival; RS, recurrence score; HR, hormone receptor; HER2, human epidermal growth factor receptor 2; CI, confidence interval.