Table 1.
Invasive breast cancer characteristics by study groups
| Combined Hormone Therapy (n=385 invasive breast caners) | Placebo (n=293 invasive breast caners) | ||||
|---|---|---|---|---|---|
| N | % | N | % | P-Value1 | |
| Tumor size, mean (SD), cm | 1.7 | (1.3) | 1.5 | (1.1) | 0.11 |
| Tumor size | 0.34 | ||||
| No tumor found/no primary mass | 1 | 0.3 | 2 | 0.7 | |
| Microscopic focus or foci | 9 | 2.5 | 15 | 5.5 | |
| ≤ 0.5 cm | 38 | 10.5 | 27 | 9.9 | |
| >0.5 - 1 cm | 92 | 25.3 | 84 | 30.7 | |
| >1 - 2 cm | 146 | 40.2 | 98 | 35.8 | |
| >2 cm | 77 | 21.2 | 48 | 17.5 | |
| Lymph nodes examined | 0.80 | ||||
| No | 39 | 10.3 | 28 | 9.6 | |
| Yes2 | 341 | 89.7 | 263 | 90.4 | |
| Number of positive lymph nodes | 0.06 | ||||
| None | 258 | 76.3 | 218 | 83.8 | |
| 1-3 | 60 | 17.8 | 34 | 13.1 | |
| >3 | 20 | 5.9 | 8 | 3.1 | |
| Positive lymph nodes | 0.03 | ||||
| No | 258 | 76.1 | 218 | 83.5 | |
| Yes3 | 81 | 23.9 | 43 | 16.5 | |
| SEER – stage | 0.05 | ||||
| Localized | 288 | 75.2 | 238 | 81.2 | |
| Regional | 86 | 22.5 | 46 | 15.7 | |
| Distant | 5 | 1.3 | 7 | 2.4 | |
| Unknown | 4 | 1.0 | 2 | 0.7 | |
| SEER stage (regional/distant) | 0.07 | ||||
| No | 288 | 76.0 | 238 | 81.8 | |
| Yes | 91 | 24.0 | 53 | 18.2 | |
| Histology | 0.41 | ||||
| Ductal | 238 | 62.1 | 195 | 66.6 | |
| Lobular | 36 | 9.4 | 20 | 6.8 | |
| Ductal and Lobular | 57 | 14.9 | 35 | 11.9 | |
| Tubular | 13 | 3.4 | 9 | 3.1 | |
| Other | 39 | 10.2 | 34 | 11.6 | |
| Grade | 0.51 | ||||
| Well differentiated | 100 | 26.1 | 67 | 22.9 | |
| Moderately differentiated | 140 | 36.6 | 116 | 39.6 | |
| Poorly differentiated/anaplastic | 92 | 24.0 | 77 | 26.3 | |
| Unknown | 51 | 13.3 | 33 | 11.3 | |
| Estrogen receptor | 0.81 | ||||
| Positive | 308 | 80.0 | 230 | 78.5 | |
| Negative | 48 | 12.5 | 33 | 11.3 | |
| Borderline | 0 | 0.0 | 1 | 0.3 | |
| Unknown/Not Done/Missing | 29 | 7.5 | 29 | 9.9 | |
| Progesterone receptor | 0.92 | ||||
| Positive | 262 | 68.1 | 194 | 66.2 | |
| Negative | 86 | 22.3 | 62 | 21.2 | |
| Borderline | 5 | 1.3 | 3 | 1.0 | |
| Unknown/Not Done/Missing | 32 | 8.3 | 34 | 11.6 | |
| HER2 overexpression | 0.17 | ||||
| Yes | 54 | 14.0 | 26 | 8.9 | |
| No | 233 | 60.5 | 161 | 54.9 | |
| Borderline | 3 | 0.8 | 1 | 0.3 | |
| Unknown/Not Done/Missing | 95 | 24.7 | 105 | 35.8 | |
| Triple negative tumor | 0.61 | ||||
| Triple negative(ER-/PR-/HER2-) | 26 | 6.8 | 14 | 4.8 | |
| Other (includes borderline) | 259 | 67.3 | 173 | 59.0 | |
| Unknown/Missing ER/PR/HER2 all/some | 100 | 26.0 | 106 | 36.2 | |
1
P-value based on Fisher's exact test of association. Bracket indicates the subset of categories for a tumor characteristic that were tested for association with randomization assignment. If there is no bracket, then all categories for a tumor characteristic were tested for association with tumor characteristic.
2
Ten instances (5 active and 5 placebo) where lymph nodes were examined but number examined was not specified.
3
Two instances (1 active and 1 placebo) where positive nodes determined but number of positive nodes not specified.