Sorafenib (SOR) plus docetaxel (DOC) as first-line therapy in patients with HER2-negative metastatic breast cancer (MBC): A randomized, placebo-controlled phase II trial.

1072 Background: Anti-angiogenic therapy with the monoclonal anti-VEGF antibody Bevacizumab (Bev) in combination with chemotherapy increases overall response rates (ORR) and progression free survival (PFS) but without impact on overall survival. SOR, an anti-angiogenic multi-tyrosine kinase inhibitor (TKI) also targeting tumor growth directly, is approved for advanced renal cell and hepatocellular carcinoma. Three phase IIb trials (SOLTI-0701, NU07B1, AC01B07) have reported efficacy of SOR in combination with chemotherapy in MBC, even after prior Bev (AC01B07). As TKIs might have superior activity we conducted this trial in first-line MBC. Methods: Pts were randomized to DOC (75mg/m2 q3w) + either SOR (400 p.o. twice daily (BID)) or placebo. Following an amendment after the inclusion of 63 pts, the SOR starting dose was reduced to 400 mg/d for cycle 1 and 600 mg/d for cycle 2 with the option to increase the dose to 800 mg/d after the second cycle in the absence of > grade 1 toxicities. The planned sample ...