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

• Status: Completed
• Trial end date: 2012-02-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fudan University
• Collaborator: Istituto Superiore di Sanità
• Treatments: Cisplatin; Docetaxel; Esomeprazole; Proton Pump Inhibitors

Criteria

Inclusion Criteria:

• Signed informed consent.

• Female, ≥ 18 years.

• Histologically confirmed invasive breast cancer.

• Metastatic breast cancer.

• Karnofsky Performance Status ≥60.

• Life expectancy of more than 3 months.

• Subject must have adequate organ function.

• Normal laboratory values: hemoglobin > 80g/dl, neutrophils > 2.0×10^9/L, platelets > 80×10^9/L, serum creatinine < upper limit of normal (ULN), serum bilirubin < ULN, ALT and AST < 2.5×ULN, AKP < 5×ULN.

• Negative serum pregnancy test for women with childbearing potential.

• Good conditions for infusion and willing to have phlebotomy throughout whole study.

• Have ceased anti-tumor treatments including endocrinotherapy and bio-targeted therapy for more than 28 days.

• Have at least one target lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria.

• No prior use of docetaxel or has used docetaxel in adjuvant/neo-adjuvant chemotherapy and has a relapse free survival of at least 12 months.

Exclusion Criteria:

• Pregnant or lactating females.

• History of other malignancy. However, subjects who have been disease-free for 5 years, or subjects with a history of completely resected non-melanoma skin cancer or successfully treated in situ carcinoma are eligible.

• Concurrent disease or condition that would make the subject inappropriate for study participation, or any serious medical disorder that would interfere with the subject's safety.

• Active or uncontrolled infection.

• Known history of uncontrolled or symptomatic angina, arrhythmias, or congestive heart failure.

• Concomitant with brain metastases.

• Have received chemotherapy after metastasis.