Table 2.
Participant characteristics
| Characteristic | ZA | Observation |
|---|---|---|
| No. of participants | 36 | 32 |
| Median age at study entry (Range) | 54.5 yrs (41–83) | 50.5 yrs (37 – 65) |
| Race | ||
| Caucasian | 35 | 32 |
| Hispanic | 1 | 0 |
| Performance status | ||
| 0 | 31 | 28 |
| 1 | 4 | 3 |
| Unknown | 1 | 1 |
| Tumor size | ||
| ≤2cm | 14 | 2 |
| 2.1–5cm | 11 | 18 |
| >5cm | 9 | 9 |
| Inflammatory | 1 | 3 |
| Unknown | 1 | 0 |
| Lymph node status | ||
| Node Negative | 1 | 1 |
|
Node Positive 1–3 nodes ≥4 nodes |
35 | 31 |
| 15 | 5 | |
| 20 | 26 | |
| Receptor Status | ||
| ER+ and/or PR+ | 29 | 29 |
| ER-/PR- | 7 | 3 |
| HER2Amplified | 3 | 5 |
| HER2Not Amplified/ Unknown | 33 | 27 |
| Adjuvant chemotherapy | 33 | 31 |
| None | 3 | 1 |
| Any adjuvant chemotherapy | 33 | 31 |
| Trastuzumab | 1 | 4 |
| Received Adjuvant Radiation | 24 | 26 |
| Endocrine Therapy During Year 1 on Study | ||
| None | 5 | 3 |
| Tamoxifen (Tam) or other SERM | 23 | 18 |
| Aromatase Inhibitor (AI) | 4 | 5 |
| Tam switched to AI during study year | 1 | 2 |
| Lumbar spine (L1-L4) total at baseline, g/cm3, mean (SD) | 1.148 (0.161) | 1.144 (0.185) |
| Femoral neck (FN) total at baseline, g/cm3, mean (SD) | 0.937 (0.144) | 0.942 (0.146) |
| Total femur (TF) total at baseline, g/cm3, mean (SD) | 0.982 (0.137) | 0.983 (0.143) |
| Trochanter (T) total at baseline, g/cm3, mean (SD) | 0.793 (0.118) | 0.807 (0.131) |
| Calcaneus (OC) total at baseline, g/cm3, mean (SD) | 0.498 (0.094) | 0.498 (0.081) |
| Time from Diagnosis to Enrollment on Trial, median in years (range) | 2.0 (0.8–5.0) | 2.1 (0.8–4.8) |