Table 1.
Characteristics of sample
| Characteristic | Total | Before Feb. 2008 | Mar. 2008–Nov. 2011 | After Nov. 2011 |
|---|---|---|---|---|
| No. (%) | No. (%) | No. (%) | No. (%) | |
| Trials | 52 (100) | 29 (53.8) | 19 (36.5) | 4 (7.7) |
| Completed | 48 (92.3) | 28 (96.5) | 19 (100.0) | 1 (25.0) |
| Design | ||||
| Phase 3 | 14 (26.9) | 8 (27.6) | 5 (26.3) | 1 (25.0) |
| Randomized | 23 (44.2) | 13 (44.8) | 6 (31.6) | 4 (100.0) |
| Double-blind | 7 (13.5) | 5 (17.2) | 1 (5.3) | 1 (25.0) |
| Single arm | 29 (55.8) | 16 (55.2) | 13 (68.4) | 0 (0.0) |
| Arms > 2 | 8 (15.4) | 6 (20.7) | 1 (5.3) | 1 (25.0) |
| BVZ in all arms | 3 (5.8) | 0 (0.0) | 3 (15.8) | 0 (0.0) |
| Primary endpoint | ||||
| ORR | 13 (25.0) | 7 (24.1) | 6 (31.6) | 0 (0.0) |
| PFS | 33 (63.5) | 19 (65.5) | 11 (57.9) | 3 (75.0) |
| OS | 1 (1.9) | 0 (0.0) | 1 (5.3) | 0 (0.0) |
| Dose/safety | 4 (7.7) | 3 (10.3) | 1 (5.3) | 0 (0.0) |
| Other | 1 (1.9) | 0 (0.0) | 0 (0.0) | 1 (25.0) |
| Tumor type | ||||
| HER2- | 27 (51.9) | 15 (51.7) | 10 (52.6) | 2 (50.0) |
| TNBC | 7 (13.5) | 1 (3.4) | 5 (26.3) | 1 (25.0) |
| HER2+ | 5 (9.6) | 4 (13.8) | 1 (5.3) | 0 (0.0) |
| Data availability* | ||||
| Published | 27 (56.3) | 16 (57.1) | 10 (55.6) | 1 (100.0) |
| Results on ClinicalTrials.gov | 26 (54.2) | 19 (67.9) | 6 (33.3) | 1 (100.0) |
| Outcome† | ||||
| Favorable | 6 (13%) | 3 (10.7) | 3 (20.0) | 0 (0.0) |
| Unfavorable | 13 (29%) | 10 (35.7) | 2 (13.3) | 1 (100.0) |
| Mixed | 1 (2%) | 0 (0.0) | 1 (6.7) | 0 (0.0) |
| Terminated | 10 (21%) | 6 (21.4) | 4 (22.2) | 0 (0.0) |
| Unknown | 14 (29%) | 9 (32.1) | 5 (27.8) | 0 (0.0) |
*
For calculating the percentage of trials with available data, the denominator excludes active trials. Abbreviations: ORR = objective response rate; PFS = progression-free survival; OS = overall survival; TNBC = triple-negative breast cancer.
†
For calculating the percentage of favorable, unfavorable, and mixed outcomes, the denominator excludes active trials and trials that contained BVZ in all treatment arms. For calculating the percentage of terminated trials or trials whose outcome is unknown, the denominator excludes active trials.