Advanced Breast Cancer
Conditions
Keywords
advanced breast cancer, docetaxol, capecitabine, cisplatin
Brief 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.
Detailed 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.
Interventions
DRUGdocetaxol, cisplatin, capecitabine
docetaxol(75mg/m2 d1 every 21 days) combined with cisplatin(75mg/m2 d1 every 21 days) VS docetaxol( 75mg/m2 d1 every 21 days) combined with capecitabine(2000mg/m2 d1-14 every 21 days)
Sponsors
Chinese Academy of Medical Sciences
Academy Military Medical Science, China
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR,TTP,TTF and 2 year PFS | 2008-2010 |
Secondary
| Measure | Time frame |
|---|---|
| safety and QOL | 2008-2010 |
Outcome results
None listed