Introduction
Methods
Study design
Patients and treatment
Endpoints
Statistical analysis
Results
Patients and disposition
Talazoparib (N = 19) | |
---|---|
Age (years), n (%) | |
18–44 | 7 (36.8) |
45–64 | 6 (31.6) |
≥ 65 | 6 (31.6) |
Mean | 54.5 |
Range | (32–77) |
Race, n (%) | |
Japanese | 19 (100.0) |
ECOG performance status, n (%) | |
0 | 17 (89.5) |
1 | 2 (10.5) |
2 | 0 |
Primary diagnosis, n (%) | |
HR+/HER2 negative breast cancer | 10 (52.6) |
TNBC | 9 (47.4) |
BRCA mutational status, n (%) | |
BRCA1 | 5 (26.3) |
BRCA2 | 14 (73.7) |
Number of prior systemic medications for advanced or metastatic breast cancer, n (%) | |
0 regimens | 9 (47.4) |
1 regimen | 7 (36.8) |
2 regimens | 0 |
3 regimens | 2 (10.5) |
≥ 4 regimens | 1 (5.3) |
Number of prior adjuvant and neo-adjuvant medications, n (%) | |
0 regimens | 4 (21.1) |
1 regimen | 1 (5.3) |
2 regimens | 6 (31.6) |
3 regimens | 6 (31.6) |
≥ 4 regimens | 2 (10.5) |
Efficacy
Safety
Talazoparib (N = 19) | |
---|---|
Patients evaluable for AEs, n (%) | 19 (100) |
Any AEs, n (%) | 19 (100) |
Serious AEs, n (%) | 0 |
Maximum grade 3 or 4 AEs, n (%) | 10 (52.6) |
Maximum grade 5 AEs, n (%) | 0 |
Discontinuations from study due to AEsa, n (%) | 0 |
Study-drug discontinuations due to AE and continue studyb, n (%) | 0 |
Study-drug interruption due to AEs, n (%) | 8 (42.1) |
Dose reduction due to AEs, n (%) | 9 (47.4) |
Talazoparib (N = 19) | |
---|---|
Number of patients by preferred term, n (%) | |
ANEMIAa | 13 (68.4) |
Grade ≥ 3 | 9 (47.4) |
NEUTROPENIAa | 12 (63.2) |
Grade ≥ 3 | 4 (21.1) |
LEUKOPENIAa | 8 (42.1) |
Grade ≥ 3 | 2 (10.5) |
Alopeciaa,b | 6 (31.6) |
Stomatitisa,b | 6 (31.6) |
THROMBOCYTOPENIAa,b | 6 (31.6) |
Malaisea,b | 5 (26.3) |
Constipationa,b | 3 (15.8) |
Dizzinessa,b | 3 (15.8) |
Headachea,b | 3 (15.8) |
Nauseaa,b | 3 (15.8) |
Dysgeusiaa,b | 2 (10.5) |
Dyspneaa,b | 2 (10.5) |
Fatiguea,b | 2 (10.5) |