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

NCT01069081 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 94

Last updated 2015-03-06

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Arm C

Docetaxel and cisplatin chemotherapy combined with high dose PPI. Docetaxel 75mg/m2 intravenous d1, cisplatin 75mg/m2 intravenous d1,repeated every 3 weeks.Each patient is designed to receive no more than 6 cycles of chemotherapy.PPI 200mg p.o. d1-3 every week for 66 weeks.

DRUG

Arm B

Docetaxel and cisplatin chemotherapy combined with lower dose PPI. Docetaxel 75mg/m2 intravenous d1, cisplatin 75mg/m2 intravenous d1,repeated every 3 weeks.Each patient is designed to receive no more than 6 cycles of chemotherapy.PPI 160mg p.o. d1-3 every week for 66 weeks.

DRUG

Arm A

Docetaxel and cisplatin chemotherapy. Docetaxel 75mg/m2 intravenous d1, cisplatin 75mg/m2 intravenous d1,repeated every 3 weeks.Each patient is designed to receive no more than 6 cycles of chemotherapy.

Sponsors & Collaborators

  • Istituto Superiore di Sanità

    collaborator OTHER

  • Fudan University

    lead OTHER

Principal Investigators

  • XiChun Hu, MD,Ph. D · Fudan University

  • Antonio Chiesi · Istituto Superiore di Sanità

  • Stefano Fais, MD PHD · Istituto Superiore di Sanità

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-08-31
Primary Completion
2012-02-29
Completion
2012-02-29

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01069081 on ClinicalTrials.gov