A Randomised,Multi-Center Study of Docetaxol Plus Capecitabine or Cisplatin in Anthracycline-Pretreated Patients With Advanced Breast Cancer
This trial is active, not recruiting.
|Condition||advanced breast cancer|
|Treatment||docetaxol, cisplatin, capecitabine|
|Sponsor||Academy Military Medical Science, China|
|Collaborator||Chinese Academy of Medical Sciences|
|Start date||May 2008|
|End date||December 2009|
|Trial size||120 participants|
|Trial identifier||NCT00717951, CBCSG003, TAX625|
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 potential effective drug for triple negative breast cancer.The study primary objective:Assess ORR,TTP,TTF and 2 year PFS rate between docetaxol+capecitabine and docetaxol+cisplatin.
The second objective:Assess the safety and QOL.
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
ORR,TTP,TTF and 2 year PFS
time frame: 2008-2010
safety and QOL
time frame: 2008-2010
Female participants at least 18 years old.
Inclusion Criteria: - 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 Criteria: - 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
|Official title||A Randomised,Multi-Center Study of Docetaxol Plus Capecitabine or Cisplatin in Anthracycline-Pretreated Patients With Advanced Breast Cancer|
|Principal investigator||jiang zefei, Ph.D|
|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 laboratory values within the following parameters:ANC ≥1.5×109/L,Hemoglobin≥10.0 g/dl，Platelet≥100×109/L. 5. signed ICF The patients will be randomised two group: docetaxol+capecitabine and docetaxol+cisplatin. According to AE, the dose will be adjusted.|
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