A Randomised,Multi-Center Study of Docetaxol Plus Capecitabine or Cisplatin in Anthracycline-Pretreated Patients With Advanced Breast Cancer
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.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
ORR,TTP,TTF and 2 year PFS
2008-2010
Yes
jiang zefei, Ph.D
Principal Investigator
Academy MMS,China
China: Food and Drug Administration
TAX625
NCT00717951
May 2008
May 2010
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