Table 1.
Metformin (n = 237) | Placebo (n = 255) | |||
---|---|---|---|---|
Age (mean, SD) | 52.1 (±12) | 52.6 (±) | ||
| ||||
Race | ||||
Asian | 4 | (1.7%) | 6 | (2.4%) |
Black | 2 | (0.8%) | 3 | (1.2%) |
Native | 3 | (1.2%) | 3 | (1.2%) |
White | 227 | (95.8%) | 239 | (93.7%) |
Unknown | 1 | (0.4%) | 4 | (1.6%) |
| ||||
BMI (median, range) | 27.37 | (17.68, 46.48) | 27.27 | (18.73, 46.07) |
| ||||
T stage (neoadjuvant) | ||||
cT1 | 3 | (9.6%) | 1 | (3.7%) |
cT2 | 18 | (58.1%) | 13 | (48.1%) |
cT3 | 10 | (32.3%) | 13 | (48.1%) |
| ||||
N stage (neoadjuvant) | ||||
cN0 | 6 | (19.4%) | 8 | (29.6%) |
cN1-3 | 25 | (80.6%) | 19 | (70.4%) |
| ||||
T stage (adjuvant) | ||||
T1 | 74 | (36.0%) | 87 | (38.2%) |
T2 | 114 | (55.3%) | 124 | (54.4%) |
T3 | 18 | (8.7%) | 17 | (7.4%) |
| ||||
N stage (adjuvant) | ||||
N0 | 97 | (47.1%) | 116 | (50.9%) |
N1-3 | 109 | (52.9%) | 112 | (49.1%) |
| ||||
Hormone receptor | ||||
ER and/or PgR positive | 173 | (73.0%) | 190 | (72.8%) |
ER and PgR negative | 64 | (27.0%) | 71 | (27.2%) |
| ||||
HER2 | ||||
Positive | 41 | (17.3%) | 36 | (14.1%) |
Negative | 196 | (82.7%) | 219 | (85.9%) |
| ||||
Histologic Grade | ||||
Grade I | 24 | (10.1%) | 24 | (9.4%) |
Grade II | 87 | (36.7%) | 100 | (39.2%) |
Grade III | 125 | (52.7%) | 130 | (51.0%) |
Unknown | 1 | (0.4%) | 1 | (0.4%) |
| ||||
Surgery | ||||
Mastectomy | 117 | (49.4%) | 106 | (41.6%) |
Lumpectomy | 120 | (50.6%) | 149 | (58.4%) |
| ||||
Chemotherapy | ||||
Yes - neoadjuvant | 31 | (13.1%) | 27 | (10.6%) |
- adjuvant | 179 | (75.5%) | 197 | (77.3%) |
No | 27 | (11.4%) | 31 | (12.1%) |
| ||||
Hormone Therapy | ||||
Yes - neoadjuvant | 3 | (1.3%) | 0 | (0%) |
- adjuvant | 151 | (63.7%) | 173 | (67.8%) |
No | 83 | (35.0%) | 82 | (32.2%) |
| ||||
Adjuvant Trastuzumab | ||||
Yes | 40 | (16.9%) | 33 | (12.9%) |
No | 197 | (83.1%) | 222 | (87.1%) |
Range = Interquartile Range; SD= standard deviation; ER = estrogen receptor; PgR = progesterone receptor.