Table 3.
Patient Disposition.
| n (%) | Letrozole Part A (N=20) |
Anastrozole Part B (N=16) |
Tamoxifen Part C (N=16) |
Exemestane Part D (N=15) |
Parts A–D N=67 |
|---|---|---|---|---|---|
| On treatment | 1 (5.0) | 5 (31.8) | 3 (18.8) | 2 (13.3) | 11 (16.4) |
| Discontinued treatment | 19 (95.0) | 11 (68.8) | 13 (81.3) | 13 (86.7) | 56 (83.6) |
| Reason for treatment discontinuation | |||||
| Adverse event a | 6 (30.0) | 3 (18.8) | 1 (6.3) | 1 (6.7) | 11 (16.4) |
| Diarrhea | 4 (20.0) | 0 (0.0) | 0 (0.0) | 1 (6.7) | 5 (7.5) |
| Death | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Non-compliance with study drug | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (6.7) | 1 (1.5) |
| Physician decision | 2 (10.0) | 0 (0.0) | 2 (12.5) | 1 (6.7) | 5 (7.5) |
| Progressive disease | 8 (40.0) | 7 (43.8) | 8 (50.0) | 8 (53.3) | 31 (46.3) |
| Withdrawal by subject | 3 (15.0) | 1 (6.3) | 2 (12.5) | 2 (13.3) | 8 (11.9) |
a
Adverse events of ≥10% incidence in at least one part of the study are listed.