Table 2.
Results of five large, open-label clinical trials investigating the adjuvant use of zoledronic acid in patients with breast cancer.
| Study | ABCSG-12 [36] | AZURE [37] | E-ZO-FAST [38] | Z-FAST [38] | ZO-FAST [39] |
|---|---|---|---|---|---|
| Study design | Goserelin with tamoxifen or anastrozole ± zoledronic acid (4 mg Q6M) | SOC ± zoledronic acid (6 doses 4 mg Q3W–Q4W, then 4 mg Q3M–Q6M) | Upfront zoledronic acid (4 mg Q6M) vs. delayed treatment | Upfront zoledronic acid (4 mg Q6M) vs. delayed treatment | Upfront zoledronic acid (4 mg Q6M) vs. delayed treatment |
| Number of patients | 1803 | 3360 | 527 | 602 | 1065 |
| Primary endpoint | Disease-free survival | Disease-free survival | LS BMD at 12 months | LS BMD at 12 months | LS BMD at 12 months |
| Median length of follow up, months | 76 | 59 | 36 | 54 | 60 |
| Disease-free survival, HR (95% CI) | 0.73 (NR) | 0.98 (0.85, 1.13) | 1.76 (0.83, 3.69) | 0.80 (0.45, 1.41) | 0.66 (0.44, 0.97) |
| p Value | 0.022 | 0.79 | NS | NS | 0.0375 |
| Overall survival, HR (95% CI) | 0.59 (NR) | 0.85 (0.72, 1.01) | NR | NR | 0.69 (0.42, 1.14) |
| p Value | 0.027 | 0.07 | NR | NR | 0.1463 |
BMD, bone mineral density; CI, confidence interval; HR, hazard ratio; LS, lumbar spine; NR, not reported; NS, not significant; SOC, standard of care; vs., versus.