Table 3.
Clinical Trial | Phase | Treatment | sBRCA | gBRCA | Results |
---|---|---|---|---|---|
Olaparib expanded [70] | 2 | Olaparib | n = 16 | n = 0 | ORR for sBRCA1/2 carriers was 50%. Median PFS for sBRCA1/2 carriers was 6.2 months. |
COMETAbreast study [68] | 2 | Olaparib | n = 11 | n = 0 | Heavily pre-treated patients, no clinically or statistically significant antitumor activity. Median PFS: 2 months (95% CI: 1–4) Median OS: 9 months (95% CI: 1–14) |
LUCY study [69] | 3b | Olaparib | n = 3 | n = 253 | Small patient number for sBRCA, limited assessment of the clinical effectiveness. |
Walsh et al. [71] | rObs | Olaparib | n = 4 | + | Median PFS:
|
RUBY trial [73] | 2 | rucaparib | n = 4 | + | sBRCA1: 1 SD sBRCA2: 1 PR |
gBRCA: germline BRCA mutation; ORR: objective response rate; OS: overall survival; PFS: progression-free survival; PR: partial response; rObs: a single institution, retrospective observational study; SD: stable disease.