Phase II Study of Docetaxel and Cisplatin Chemotherapy Versus Docetaxel and Cisplatin Chemotherapy Combined With High Dose Proton Pump Inhibitor in Metastatic Breast Cancer
High dose proton pump inhibitor (PPI) has been proved beneficial and it improved efficacy
when combined with chemotherapy in preclinical and clinical trials.This study was designed
to explore whether adding a proton pump inhibitor into docetaxel and cisplatin chemotherapy
improves efficacy and does not affect tolerability in metastatic breast cancer.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Time to progression
six weeks
Yes
XiChun Hu, MD,Ph. D
Principal Investigator
Fudan University
China: Ethics Committee
Fudan BR2010-01
NCT01069081
August 2009
February 2012
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