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

Fudan University

Status and phase: Completed; Phase 2

Conditions: Breast Cancer; Metastasis, Neoplasm

Treatments: Drug: Arm B; Drug: Arm A; Drug: Arm C

Study type: Interventional

Funder types: Other

Identifiers

NCT01069081

Fudan BR2010-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 94 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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94 participants in 3 patient groups

arm A

Active Comparator group

Description:

docetaxel and cisplatin chemotherapy

Treatment:

Drug: Arm A

arm B

Experimental group

Description:

docetaxel and cisplatin chemotherapy combined with PPI 160mg per day.

Treatment:

Drug: Arm B

arm C

Experimental group

Description:

docetaxel and cisplatin chemotherapy combined with PPI 200mg per day.

Treatment:

Drug: Arm C