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

Sponsors and Collaborators:	Academy Military Medical Science, China Chinese Academy of Medical Sciences
Information provided by:	Academy Military Medical Science, China
ClinicalTrials.gov Identifier:	NCT00717951

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 II

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Docetaxel Cisplatin Capecitabine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Efficacy Study
Official Title:	A Randomised,Multi-Center Study of Docetaxol Plus Capecitabine or Cisplatin in Anthracycline-Pretreated Patients With Advanced Breast Cancer

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
A: Experimental 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)
B: Experimental 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

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

Keywords provided by Academy Military Medical Science, China:

advanced breast cancer
docetaxol
capecitabine
cisplatin

Study placed in the following topic categories:

Docetaxel
Capecitabine
Cisplatin

Skin Diseases
Breast Neoplasms
Breast Diseases

Additional relevant MeSH terms:

Antimetabolites
Neoplasms
Antimetabolites, Antineoplastic
Neoplasms by Site
Molecular Mechanisms of Pharmacological Action

Radiation-Sensitizing Agents
Antineoplastic Agents
Therapeutic Uses
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009