Overview

This trial is active, not recruiting.

Condition advanced breast cancer
Treatment docetaxol, cisplatin, capecitabine
Phase phase 2
Sponsor Academy Military Medical Science, China
Collaborator Chinese Academy of Medical Sciences
Start date May 2008
End date December 2009
Trial size 120 participants
Trial identifier NCT00717951, CBCSG003, TAX625

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Arm A is "docetaxol+capecitabine" chemotherapy
docetaxol, 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)
(Experimental)
Arm B is "docetaxol+cisplatin" chemotherapy
docetaxol, 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)

Primary Outcomes

Measure
ORR,TTP,TTF and 2 year PFS
time frame: 2008-2010

Secondary Outcomes

Measure
safety and QOL
time frame: 2008-2010

Eligibility Criteria

Female participants at least 18 years old.

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

Additional Information

Official title A Randomised,Multi-Center Study of Docetaxol Plus Capecitabine or Cisplatin in Anthracycline-Pretreated Patients With Advanced Breast Cancer
Principal investigator jiang zefei, Ph.D
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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2008.
Information provided to ClinicalTrials.gov by Academy Military Medical Science, China.