Table 1.
Patients characteristics in discovery and validation cohort
| Variable | Discovery cohort | Validation cohort | P value | ||
|---|---|---|---|---|---|
| Total, N | 117 | 74 | |||
| Age | |||||
| Mean (range) | 49.03 (25–77) | 48.58 (27–72) | 0.769 | ||
| Race | 0.414 | ||||
| White | 87 | 74.35% | 53 | 71.62% | |
| Asian | 10 | 8.55% | 3 | 4.05% | |
| Black | 9 | 7.69% | 9 | 12.16% | |
| Unknown | 11 | 9.41% | 8 | 10.81% | |
| Native Hawaiian or other Pacific Islander | 0 | 0 | 1 | 1.35% | |
| Lesion type | 0.309 | ||||
| Multiple masses | 65 | 55.56% | 33 | 44.59% | |
| Multiple NME | 5 | 4.27% | 6 | 8.11% | |
| Single mass | 43 | 36.75% | 30 | 40.54% | |
| Single NME | 4 | 3.42% | 5 | 6.76% | |
| HER2 | 0.974 | ||||
| Positive | 30 | 25.64% | 18 | 24.32% | |
| Negative | 87 | 74.36% | 56 | 75.68% | |
| HR | 0.959 | ||||
| Positive | 71 | 60.68% | 46 | 62.16% | |
| Negative | 46 | 39.32% | 28 | 37.84% | |
| SBR grade | 0.592 | ||||
| I (Low) | 3 | 2.56% | 2 | 2.70% | |
| II (Intermediate) | 36 | 30.77% | 17 | 22.97% | |
| III (High) | 77 | 65.81% | 55 | 74.32% | |
| Unknown | 1 | 0.85% | 0 | 0 | |
| MRLD | |||||
| Mean (range) | 4.02 (0.44–15) | 4.73 (1.6–13.2) | 0.049 | ||
| pCR | 1.000 | ||||
| pCR | 36 | 30.77% | 23 | 31.08% | |
| non-pCR | 81 | 69.23% | 51 | 68.92% | |
| Treatment arm* | 0.351 | ||||
| Paclitaxel | 23 | 19.66% | 15 | 20.27% | |
| Paclitaxel + Trastuzumab | 3 | 2.56% | 1 | 1.35% | |
| Paclitaxel + MK-2206 | 11 | 9.40% | 6 | 8.11% | |
| Paclitaxel + Trastuzumab + MK-2206 | 9 | 7.69% | 2 | 2.70% | |
| Paclitaxel + Trebananib | 27 | 23.08% | 12 | 16.22% | |
| Paclitaxel + Trastuzumab + Trebananib | 2 | 1.71% | 4 | 5.41% | |
| Trastuzumab + Pertuzumab | 10 | 8.55% | 4 | 5.41% | |
| Paclitaxel + Trastuzumab + Pertuzumab | 6 | 5.13% | 4 | 5.41% | |
| Paclitaxel + Ganitumab | 24 | 20.51% | 20 | 27.03% | |
| Paclitaxel + Ganetespib | 2 | 1.71% | 3 | 4.05% | |
| Paclitaxel + Neratinib | 0 | 0 | 2 | 2.70% | |
| Unknown | 0 | 0 | 1 | 1.35% | |
NME, non-mass-like enhancement; HR, hormone receptor; HER2, human epidermal growth factor receptor 2; SBR, grade Scarff-Bloom-Richardson grade; MRLD, MRI measured longest diameter (cm) at baseline (T0) study; pCR, pathologic complete response; MK-2206, AKT inhibitor
*All treatment arms are followed by 4 cycles of doxorubicin/cyclophosphamide