Capecitabine and Pseudomonas Aeruginosa Combination in Metastatic Breast Cancer (MBC)

NCT01380808 ↗

Phase 2 Completed 100 enrolled Fudan University

NaSingle-groupOpen-labelTreatment

Summary

The progression free survival could be prolonged adding pseudomonas aeruginosa to monotherapy capecitabine.

Timeline

Start: 2011-05
Primary completion: 2013-07
Completion: 2013-07

Outcome

Missed primary endpoint

paper Median progression-free survival (PFS) was 4.0 months [95 % confidence interval (CI) 3.0-4.9], which was not significantly different from that in historical controls. PMID 25768439 ↗

Publications

Lv F, Cao J, Liu Z, Wang Z, Zhang J, Zhang S, Wang L, Zhao X, Shao Z, Wang B, Hu X. Phase II study of Pseudomonas aeruginosa-Mannose-Sensitive hemagglutinin in combination with capecitabine for Her-2-negative metastatic breast cancer pretreated with anthracycline and taxane. PLoS One. 2015 Mar 13;10(3):e0118607. doi: 10.1371/journal.pone.0118607. eCollection 2015.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Capecitabine	Small molecule	1000 mg/m2	Oral
Subject	PA-MSHA	Unknown	1 ml	Subcutaneous