Status:
COMPLETED
Sequential Versus Simultaneous Use of Vinorelbine and Capecitabine in Patients With Metastatic Breast Cancer (MBC)
Lead Sponsor:
Fudan University
Conditions:
Breast Cancer
Metastasis, Neoplasm
Eligibility:
FEMALE
18-70 years
Phase:
PHASE2
Brief 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.
Detailed Description
The administration of vinorelbine and capecitabine had been implied to be quite useful in metastatic breast cancer. This study was designed to explore whether sequential and simultaneous use of vinore...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00629148
Start Date
August 1 2007
End Date
December 1 2010
Last Update
July 7 2011
Active Locations (1)
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1
Fudan University Cancer Hospital
Shanghai, China, 200032