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Brief Title: Docetaxel and Cisplatin Chemotherapy With or Without High Dose Proton Pump Inhibitor in Metastatic Breast Cancer
Official Title: Phase II Study of Docetaxel and Cisplatin Chemotherapy Versus Docetaxel and Cisplatin Chemotherapy Combined With High Dose Proton Pump Inhibitor in Metastatic Breast Cancer
Study ID: NCT01069081
Brief 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.
Detailed Description: 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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Fudan University Cancer Hospital, Shanghai, Shanghai, China
Name: XiChun Hu, MD,Ph. D
Affiliation: Fudan University
Role: PRINCIPAL_INVESTIGATOR
Name: Antonio Chiesi
Affiliation: Istituto Superiore di Sanità
Role: PRINCIPAL_INVESTIGATOR
Name: Stefano Fais, MD PHD
Affiliation: Istituto Superiore di Sanità
Role: STUDY_DIRECTOR