A Randomised,Multi-Center Study of Docetaxol Plus Capecitabine or Cisplatin in Anthracycline-Pretreated Patients With Advanced Breast Cancer
NCT ID: NCT00717951
Last Updated: 2008-07-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
120 participants
INTERVENTIONAL
2008-05-31
2010-05-31
Brief Summary
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The second objective:Assess the safety and QOL.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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A
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)
B
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)
Interventions
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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)
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
FEMALE
No
Sponsors
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Chinese Academy of Medical Sciences
OTHER
Academy Military Medical Science, China
INDUSTRY
Responsible Party
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Academy Millitary Medical Science, China
Principal Investigators
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jiang zefei, Ph.D
Role: PRINCIPAL_INVESTIGATOR
Academy MMS,China
References
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Hoon SN, Lau PK, White AM, Bulsara MK, Banks PD, Redfern AD. Capecitabine for hormone receptor-positive versus hormone receptor-negative breast cancer. Cochrane Database Syst Rev. 2021 May 26;5(5):CD011220. doi: 10.1002/14651858.CD011220.pub2.
Egger SJ, Chan MMK, Luo Q, Wilcken N. Platinum-containing regimens for triple-negative metastatic breast cancer. Cochrane Database Syst Rev. 2020 Oct 21;10(10):CD013750. doi: 10.1002/14651858.CD013750.
Other Identifiers
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CBCSG003
Identifier Type: -
Identifier Source: secondary_id
TAX625
Identifier Type: -
Identifier Source: org_study_id