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Breast Cancer Research
Published in: Breast Cancer Research 2/2011

01-12-2011 | Oral presentation

Design of RESILIENCE: a phase 3 trial comparing capecitabine in combination with sorafenib or placebo for treatment of locally advanced or metastatic HER2-negative breast cancer

Authors: J Baselga, F Costa, H Gomez, C Hudis, B Rapoport, H Roche, LS Schwartzberg, O Petrenciuc, M Shan, WJ Gradishar

Published in: Breast Cancer Research | Special Issue 2/2011

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Excerpt

A double-blind, randomized, phase 2b screening trial (SOLTI-0701) of sorafenib, an oral multikinase inhibitor, in patients with HER2-negative advanced breast cancer (BC), showed a statistically significant improvement in progression-free survival (PFS) in the sorafenib + capecitabine arm versus the placebo + capecitabine arm: 6.4 versus 4.1 months (hazard ratio = 0.58; one-sided P = 0.0006). Grade 3/4 toxicities were comparable except G3 hand-foot skin reaction/syndrome (HFSR/HFS) (44% vs. 14%). These results support a phase 3 trial of sorafenib + capecitabine in advanced BC. …
Metadata
Title
Design of RESILIENCE: a phase 3 trial comparing capecitabine in combination with sorafenib or placebo for treatment of locally advanced or metastatic HER2-negative breast cancer
Authors
J Baselga
F Costa
H Gomez
C Hudis
B Rapoport
H Roche
LS Schwartzberg
O Petrenciuc
M Shan
WJ Gradishar
Publication date
01-12-2011
Publisher
BioMed Central
Published in
Breast Cancer Research / Issue Special Issue 2/2011
Electronic ISSN: 1465-542X
DOI
https://doi.org/10.1186/bcr3011

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