Sequential Versus Simultaneous Use of Vinorelbine and Capecitabine in Patients With Metastatic Breast Cancer (MBC)

• Status: Completed
• Trial end date: 2010-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

The primary objective of this study is to evaluate the efficacy and tolerability of sequential use of vinorelbine and capecitabine as first line therapy in patients with MBC.

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

Details

• Lead Sponsor: Fudan University
• Treatments: Capecitabine; Vinblastine; Vinorelbine

Criteria

Inclusion Criteria:

• Signed informed consent.

• Female, ≥ 18 and ≤ 70 years.

• Histologically confirmed invasive breast cancer.

• Metastatic breast cancer.

• ECOG Performance Status of 0 to 2.

• Life expectancy of more than 3 months.

• Subject must have adequate organ function.

• Normal laboratory values: hemoglobin > 90g/dl, neutrophils > 1.5×10^9/L, platelets > 80×10^9/L, serum creatinine < 1.5×upper limit of normal (ULN), serum bilirubin < 1.5×ULN, ALT and AST < 2.5×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.

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