TABLE VI.
Results of randomized targeted therapy trials in advanced breast cancer
| n | Regimen | ORR (%) | PFS (months) | OS (months) | |
|---|---|---|---|---|---|
| PARP Inhibitors
| |||||
| Rd Phase III First-line+O’Shaughnessy64 |
261 | Cb + Gem + BSI-201 | 34 | 5.1 p=0.027a | 11.8 p=0.28b |
| 258 | Cb + Gem | 30 | 4.1 | 11.1 | |
| EGFR Targeted Therapies | |||||
| Rd Phase II First-line+Carey |
31 | Cetux to progression then Cetux + Cb | 6c | 2.0d | 12d |
| TBCRC00175 | 71 | Cetux + Cb | 17c | ||
| Rd Phase II Baselga |
115 | Cetux + Cis | 20.0 | 3.7 | 12.9 |
| BALI-172 | 58 | Cis to progression then Cetux/Cis or Cetux | 10.3 | 1.5 | 9.4 |
| Anti-Angiogenic Agents | |||||
| RD Phase II Heavily Pretreated Curgliano76 |
113 | Sunitinib | 2.7 | 2.0 | 9.4 |
| 104 | CT | 6.7 | 2.7 | 10.5 | |
a
Prespecified alpha = 0.01
b
Prespecified alpha = 0.04
c
ORR measured prior to disease progression.
d
Cetuximab + Cb cohort from both arms.
BSI-201 = iniparib; Cb = carboplatin; Cetux = cetuximab; Cis = cisplatin; CT = physician’s choice chemotherapy; EGFR = epidermal growth factor receptor; Gem = gemcitabine; n = number of patients; n/a = not available; ORR = overall response rate; OS = overall survival; PARP = poly ADP-ribose polymerase; PFS = progression-free survival; Rd = randomized