Cabozantinib for metastatic breast carcinoma: results of a phase II placebo-controlled randomized discontinuation study.

ABSTRACT:

Purpose

Cabozantinib (XL184), a multi-targeted oral tyrosine kinase inhibitor with activity against MET, VEGFR2, AXL, and other tyrosine kinases, was assessed in a cohort of metastatic breast cancer (MBC) patients in a phase II randomized discontinuation trial (RDT).

Methods

Patients received 100 mg cabozantinib daily during a 12-week lead-in stage. Those with stable disease per modified Response Evaluation Criteria in Solid Tumors version 1.0 at 12 weeks were randomized to either continue cabozantinib or receive placebo. Primary endpoints were objective response rate (ORR) during the 12-week lead-in stage and progression-free survival (PFS) after randomization. Patients were also followed for overall survival (OS).

Results

Forty-five patients with MBC and a median of

SUBMITTER: Tolaney SM 

PROVIDER: S-EPMC5065609 | biostudies-literature | 2016 Nov

REPOSITORIES: biostudies-literature