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

• Status: Unknown status
• Trial end date: 2010-05-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Academy Military Medical Science, China
• Collaborator: Chinese Academy of Medical Sciences
• Treatments: Capecitabine; Cisplatin; Docetaxel

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