Sorafenib in locally advanced or metastatic breast cancer

William J. Gradishar*

*Corresponding author for this work

Research output: Contribution to journalReview articlepeer-review

18 Scopus citations


Introduction: Sorafenib is an oral multikinase inhibitor with anti-angiogenic and anti-proliferative activity that is indicated for use in hepatocellular and renal cell carcinomas. Sorafenib is being developed in a number of solid tumors, including breast cancer (BC). Areas covered: A series of four randomized, double-blind, placebo-controlled Phase IIb screening Trials were developed to Investigate the Efficacy of Sorafenib (TIES) when added to select chemotherapies for patients with HER2-negative advanced BC with a primary endpoint of progression-free survival (PFS). Results have been varied. SOLTI-0701 reported significant PFS benefit for sorafenib plus capecitabine as first- or second-line treatment, and AC01B07 reported a modest but significant PFS benefit when sorafenib was combined with gemcitabine or capecitabine for patients whose disease had progressed during or after bevacizumab. Sorafenib plus first-line paclitaxel did not significantly improve PFS (NU07B1 study), nor did its addition to first-line docetaxel and/or letrozole (FM-B07-01 study). A Phase III trial of sorafenib plus capecitabine has been initiated. Expert opinion: Phase IIb data indicate a potential role for sorafenib in combination with select chemotherapies for HER2-negative advanced BC, but Phase III confirmatory trials are necessary. The variability in results across studies with sorafenib may be related to the chemotherapy combination and/or patient population.

Original languageEnglish (US)
Pages (from-to)1177-1191
Number of pages15
JournalExpert Opinion on Investigational Drugs
Issue number8
StatePublished - Aug 2012


  • anti-angiogenic
  • anti-proliferative
  • metastatic breast cancer
  • multikinase inhibitor
  • sorafenib

ASJC Scopus subject areas

  • Pharmacology
  • Pharmacology (medical)


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