A Study Of Sunitinib In Combination With Capecitabine Compared With Capecitabine In Patients With Breast Cancer

Summary

The treatment received with sunitinib plus capecitabine could delay tumor growth longer than with treatment with capecitabine alone.

Timeline

Start

2007-02

Primary completion

2009-12

Completion

2011-06

Outcome

Missed primary endpoint

paper Progression-free survival was not significantly different between the treatment arms PMID 23857972 ↗

registry Sunitinib + Capecitabine vs Capecitabine; p = 0.9409; Hazard Ratio (HR) 1.2239 (95% CI 0.9487 to 1.5789); Log Rank NCT00435409 ↗

Publications

• Crown JP, Dieras V, Staroslawska E, Yardley DA, Bachelot T, Davidson N, Wildiers H, Fasching PA, Capitain O, Ramos M, Greil R, Cognetti F, Fountzilas G, Blasinska-Morawiec M, Liedtke C, Kreienberg R, Miller WH Jr, Tassell V, Huang X, Paolini J, Kern KA, Romieu G. Phase III trial of sunitinib in combination with capecitabine versus capecitabine monotherapy for the treatment of patients with pretreated metastatic breast cancer. J Clin Oncol. 2013 Aug 10;31(23):2870-8. doi: 10.1200/JCO.2012.43.3391. Epub 2013 Jul 15.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Capecitabine	Small molecule	2000 mg/m2	Oral
Comparator	Capecitabine	Small molecule	2500 mg/m2	Oral
Subject	Sunitinib	Small molecule	37.5 mg	Oral

Indications