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

Advanced Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00717951
• Other study ID #: TAX625
• Secondary ID: CBCSG003
• Status: Active, not recruiting
• Phase: Phase 2
• First received: July 14, 2008
• Last updated: July 24, 2008
• Start date: May 2008
• Est. completion date: May 2010

Study information

• Verified date: May 2008
• Source: Academy Military Medical Science, China
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 120
• Est. completion date: May 2010
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Advanced Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• 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)

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Academy Military Medical Science, China	Chinese Academy of Medical Sciences

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ORR,TTP,TTF and 2 year PFS		2008-2010	Yes
Secondary	safety and QOL		2008-2010	Yes