A Randomised,Multi-Center Study of Docetaxol Plus Capecitabine or Cisplatin in Anthracycline-Pretreated Patients With Advanced Breast Cancer
- Registration Number
- NCT00717951
- Lead Sponsor
- Academy Military Medical Science, China
- 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 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.
- 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 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 120
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description A docetaxol, cisplatin, capecitabine Arm A is "docetaxol+capecitabine" chemotherapy B docetaxol, cisplatin, capecitabine Arm B is "docetaxol+cisplatin" chemotherapy
- Primary Outcome Measures
Name Time Method ORR,TTP,TTF and 2 year PFS 2008-2010
- Secondary Outcome Measures
Name Time Method safety and QOL 2008-2010