Docetaxel and Cisplatin Chemotherapy With or Without High Dose Proton Pump Inhibitor in Metastatic Breast Cancer

Phase 2 Completed 94 enrolled Fudan University Istituto Superiore di Sanità · collab

RandomizedParallel-groupOpen-labelTreatment

Summary

The objectives of this study are to evaluate the efficacy and tolerability of high dose proton pump inhibitor combined with chemotherapy in metastatic breast cancer.

Timeline

Start: 2009-08
Primary completion: 2012-02
Completion: 2012-02

Outcome

Met primary endpoint

paper A significant difference was observed between patients who had taken PPI and who not with ORR (67.7 % vs. 46.9 %, p = 0.049) PMID 26297142 ↗

Publications

Wang BY, Zhang J, Wang JL, Sun S, Wang ZH, Wang LP, Zhang QL, Lv FF, Cao EY, Shao ZM, Fais S, Hu XC. Intermittent high dose proton pump inhibitor enhances the antitumor effects of chemotherapy in metastatic breast cancer. J Exp Clin Cancer Res. 2015 Aug 22;34(1):85. doi: 10.1186/s13046-015-0194-x.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Esomeprazole	Small molecule	160 mg	Oral
Subject	Esomeprazole	Small molecule	200 mg	Oral
Background	Cisplatin	Other / unclassified	75 mg/m2	Intravenous
Background	Docetaxel	Small molecule	75 mg/m2	Intravenous