2009
DOI: 10.1016/s1359-6349(09)72031-2
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3LBA SOLTI-0701: A double-blind, randomized phase 2b study evaluating the efficacy and safety of sorafenib (SOR) compared to placebo (PL) when administered in combination with capecitabine (CAP) in patients (pts) with locally advanced (adv) or metastatic (met) breast cancer (BC)

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Cited by 23 publications
(13 citation statements)
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“…It is planned to enroll 220 patients in each trial [30]. The first of these trials was recently reported at the ESMO/ECCO conference 2009 (European Society for Medical Oncology/ European Cancer Organisation) [13 ]. Patients receiving sorafenib and capecitabine had a significantly prolonged median PFS as compared with patients on capecitabine monotherapy (6.4 vs. 4.1 months, P ¼ 0.0006).…”
Section: Sorafenibmentioning
confidence: 99%
“…It is planned to enroll 220 patients in each trial [30]. The first of these trials was recently reported at the ESMO/ECCO conference 2009 (European Society for Medical Oncology/ European Cancer Organisation) [13 ]. Patients receiving sorafenib and capecitabine had a significantly prolonged median PFS as compared with patients on capecitabine monotherapy (6.4 vs. 4.1 months, P ¼ 0.0006).…”
Section: Sorafenibmentioning
confidence: 99%
“…In one randomized Phase IIb study including 229 patients with locally advanced breast cancer or MBC, patients were treated with sorafenib plus capecitabine versus capecitabine Novel targeted agents for the treatment of advanced breast cancer | Review www.future-science.com (SOLTI-0701) [98]. The combination arm resulted in an increase in median PFS; 6.4 versus 4.1 months (HR: 0.576; p = 0.0006).…”
Section: Sorafenibmentioning
confidence: 99%
“…Notably, the toxicities associated with combining sorafenib with chemotherapy can be substantial. For example, a phase II trial of sorafenib in combination with capecitabine demonstrated that the combination resulted in a higher incidence of grade 3 hand-foot syndrome than with capecitabine alone (45% versus 13%) [53]. Phase II trials of sorafenib in combination with other cytotoxic agents, including vinorelbine and ixabepilone, are ongoing.…”
Section: Sorafenibmentioning
confidence: 99%