TBCRC 001: EGFR inhibition with cetuximab added to carboplatin in metastatic triple-negative (basal-like) breast cancer

1009 Background: Basal-like breast cancer (BBC) has low expression of ER, PR, and HER2, and is thus often called triple negative (TN). Preclinical studies suggest that BBC depend on EGFR/HER1 for proliferation. TBCRC 001 is a multicenter randomized phase II study of cetuximab (C) alone and combined with carboplatin (P) in TN metastatic BrCa (MBC). Methods: Eligibility required measurable disease, ≤ 3 prior chemotherapy, no prior platinum or EGFR inhibitor. Patients (pts) in Arm 1 received C alone (400 mg/m2, then 250 mg/m2 weekly) with P (AUC 2, 3 of 4 weeks) added upon progression (PD). Pts in Arm 2 received C+P throughout. Primary endpoint was objective response (RR, CR+PR). Results: 102 TN patients were enrolled; Arm 1 = 31 pts (closed in 3/07), Arm 2 = 71 (closed 10/07). Mean age 51, 68% white, 26% African American. 87% received prior adjuvant chemo, 54% prior chemo for MBC (24% > 1 prior). Arm 1: PR 6% (2 pts, > 40 weeks), stable disease (SD) 4%, and clinical benefit (CB=PR or SD > 6mos) 10%. Arm 2: ...