The purpose of this trial is to determine the efficacy and safety profile of TKI258 in 3 groups of patients with metastatic HER2 negative breast cancer (BC) stratified by FGFR1 and hormone receptor (HR) status.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
43
All participants received a singly daily oral dose of 500 mg dovitinib on a 5 days on/2 days off schedule in 28 cycles.
Complete responses (CR) or partial response (PR) defined according to RECIST
Time frame: Every 8 weeks
Clinical Benefit (CR, PR and SD ≥ 24 weeks after start of study treatment), PFS
Time frame: Every 8 weeks
Safety and tolerability of TKI258 treatment assessed by frequency and severity of Adverse Events.
Time frame: Monthly
Pharmacokinetic: plasma concentrations and PK parameters (e.g. Cmax, Tmax, AUC0-t)
Time frame: Study Day 1, 5 , 26, 52, 78
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