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

Launched by ACADEMY MILITARY MEDICAL SCIENCE, CHINA · Jul 17, 2008

Keywords

ClinConnect Summary

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.

Gender

FEMALE

Eligibility criteria

• 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