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

Academy Military Medical Science, China

Status and phase

Unknown

Phase 2

Conditions

Advanced Breast Cancer

Treatments

Drug: docetaxol, cisplatin, capecitabine

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00717951

CBCSG003

TAX625

Details and patient eligibility

About

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.

Full description

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.

Enrollment

120 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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