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


Phase 2
18 Years
N/A
Open (Enrolling)
Female
Advanced Breast Cancer

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Trial Information

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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

ORR,TTP,TTF and 2 year PFS

Outcome Time Frame:

2008-2010

Safety Issue:

Yes

Principal Investigator

jiang zefei, Ph.D

Investigator Role:

Principal Investigator

Investigator Affiliation:

Academy MMS,China

Authority:

China: Food and Drug Administration

Study ID:

TAX625

NCT ID:

NCT00717951

Start Date:

May 2008

Completion Date:

May 2010

Related Keywords:

  • Advanced Breast Cancer
  • advanced breast cancer
  • docetaxol
  • capecitabine
  • cisplatin
  • Breast Neoplasms

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