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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2008 by Academy Military Medical Science, China.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Chinese Academy of Medical Sciences
Information provided by:
Academy Military Medical Science, China
ClinicalTrials.gov Identifier:
NCT00717951
First received: July 14, 2008
Last updated: July 24, 2008
Last verified: May 2008
History of Changes
  Purpose

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 Intervention Phase
Advanced Breast Cancer
 Drug: docetaxol, cisplatin, capecitabine
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Academy Military Medical Science, China:

Primary Outcome Measures:
  • ORR,TTP,TTF and 2 year PFS [ Time Frame: 2008-2010 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • safety and QOL [ Time Frame: 2008-2010 ] [ Designated as safety issue: Yes ]

Enrollment: 120
Study Start Date: May 2008
Estimated Study Completion Date: May 2010
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00717951

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

No publications provided

Responsible Party: Zefei Jiang, Binghe,Xu, Academy Millitary Medical Science, China
ClinicalTrials.gov Identifier: NCT00717951     History of Changes
Other Study ID Numbers: TAX625, CBCSG003
Study First Received: July 14, 2008
Last Updated: July 24, 2008
Health Authority: China: Food and Drug Administration

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
Capecitabine
Cisplatin
Fluorouracil
Antineoplastic Agents
 Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors

ClinicalTrials.gov processed this record on May 19, 2013