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

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ClinicalTrials.gov Identifier: NCT00717951
Recruitment Status : Unknown
Verified May 2008 by Academy Military Medical Science, China.
Recruitment status was:  Active, not recruiting
First Posted : July 18, 2008
Last Update Posted : July 25, 2008
Sponsor:
Collaborator:
Chinese Academy of Medical Sciences
Information provided by:
Academy Military Medical Science, China

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.


Condition or disease Intervention/treatment Phase
Advanced Breast Cancer Drug: docetaxol, cisplatin, capecitabine Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomised,Multi-Center Study of Docetaxol Plus Capecitabine or Cisplatin in Anthracycline-Pretreated Patients With Advanced Breast Cancer
Study Start Date : May 2008
Estimated Primary Completion Date : December 2009
Estimated Study Completion Date : May 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Arm Intervention/treatment
Experimental: A
Arm A is "docetaxol+capecitabine" chemotherapy
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)
Experimental: B
Arm B is "docetaxol+cisplatin" chemotherapy
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)



Primary Outcome Measures :
  1. ORR,TTP,TTF and 2 year PFS [ Time Frame: 2008-2010 ]

Secondary Outcome Measures :
  1. safety and QOL [ Time Frame: 2008-2010 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00717951


Sponsors and Collaborators
Academy Military Medical Science, China
Chinese Academy of Medical Sciences
Investigators
Principal Investigator: jiang zefei, Ph.D Academy MMS,China

Responsible Party: Zefei Jiang, Binghe,Xu, Academy Millitary Medical Science, China
ClinicalTrials.gov Identifier: NCT00717951     History of Changes
Other Study ID Numbers: TAX625
CBCSG003
First Posted: July 18, 2008    Key Record Dates
Last Update Posted: July 25, 2008
Last Verified: May 2008

Keywords provided by Academy Military Medical Science, China:
advanced breast cancer
docetaxol
capecitabine
cisplatin

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Docetaxel
Cisplatin
Capecitabine
Antineoplastic Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators