Status:
UNKNOWN
A Randomised,Multi-Center Study of Docetaxol Plus Capecitabine or Cisplatin in Anthracycline-Pretreated Patients With Advanced Breast Cancer
Lead Sponsor:
Academy Military Medical Science, China
Collaborating Sponsors:
Chinese Academy of Medical Sciences
Conditions:
Advanced Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
Docetaxol plus capecitabine regimen is the standard treatment for the anthracycline-pretreated patients with advanced breast cancer. Cisplatin is an important drug for advanced breast cancer and poten...
Detailed Description
The study main inclusion criteria are:1.age≥18,KPS\>70.2.anthracycline-pretreated patients with advanced breast cancer.3.at least 1 measurable lesion as defined by modified RECIST criteria.4.screening...
Eligibility Criteria
Inclusion
- age≥18y
- KPS≥ 70
- pathologic diagnosis of breast cancer
- at least 1 measurable lesion as defined by modified RECIST criteria
- screening laboratory values with the following parameters: hemoglobin:≥10.0 g/dl absolute neutrophils count:≥1.5×109/L platelet:≥100×109/L creatinine clearance rate: ≥60ml/min total bilirubin: ≤1.5 ×upper limits of normal Alkaline phosphatase,Aspartate aminotransferase and Alanine aminotransferase:≤ 2.5×upper limits of normal（≤5×upper limits of normal if liver metastasis are present)
- signed ICF
- for women of child bearing potential,a negative serum or urine pregnancy test result before study entry.
Exclusion
- More than 2 cytotoxic chemotherapy treatment regimens for metastatic disease.
- prior exposure to 5-Fluorouracil continuous infusion.
- prior exposure docetaxol for metastatic disease
- Any other cancer within 5 years prior to screening with the exception of contralateral breast cancer,adequately treated cervical carcinoma in situ,or adequately treated basal or squamous cell carcinoma of skin
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2010
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT00717951
Start Date
May 1 2008
End Date
May 1 2010
Last Update
July 25 2008
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