A Randomised,Multi-Center Study of Docetaxol Plus Capecitabine or Cisplatin in Anthracycline-Pretreated Patients With Advanced Breast Cancer

A Randomised,Multi-Center Study of Docetaxol Plus Capecitabine or Cisplatin in Anthracycline-Pretreated Patients With Advanced Breast Cancer

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.

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.

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