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

Primary Purpose

Advanced Breast Cancer

Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
docetaxol, cisplatin, capecitabine
Sponsored by
Academy Military Medical Science, China
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Advanced Breast Cancer focused on measuring advanced breast cancer, docetaxol, capecitabine, cisplatin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    A

    B

    Arm Description

    Arm A is "docetaxol+capecitabine" chemotherapy

    Arm B is "docetaxol+cisplatin" chemotherapy

    Outcomes

    Primary Outcome Measures

    ORR,TTP,TTF and 2 year PFS

    Secondary Outcome Measures

    safety and QOL

    Full Information

    First Posted
    July 14, 2008
    Last Updated
    July 24, 2008
    Sponsor
    Academy Military Medical Science, China
    Collaborators
    Chinese Academy of Medical Sciences
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00717951
    Brief Title
    A Randomised,Multi-Center Study of Docetaxol Plus Capecitabine or Cisplatin in Anthracycline-Pretreated Patients With Advanced Breast Cancer
    Official Title
    A Randomised,Multi-Center Study of Docetaxol Plus Capecitabine or Cisplatin in Anthracycline-Pretreated Patients With Advanced Breast Cancer
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2008
    Overall Recruitment Status
    Unknown status
    Study Start Date
    May 2008 (undefined)
    Primary Completion Date
    December 2009 (Anticipated)
    Study Completion Date
    May 2010 (Anticipated)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Academy Military Medical Science, China
    Collaborators
    Chinese Academy of Medical Sciences

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Advanced Breast Cancer
    Keywords
    advanced breast cancer, docetaxol, capecitabine, cisplatin

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    120 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    A
    Arm Type
    Experimental
    Arm Description
    Arm A is "docetaxol+capecitabine" chemotherapy
    Arm Title
    B
    Arm Type
    Experimental
    Arm Description
    Arm B is "docetaxol+cisplatin" chemotherapy
    Intervention Type
    Drug
    Intervention Name(s)
    docetaxol, cisplatin, capecitabine
    Intervention Description
    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 Measure Information:
    Title
    ORR,TTP,TTF and 2 year PFS
    Time Frame
    2008-2010
    Secondary Outcome Measure Information:
    Title
    safety and QOL
    Time Frame
    2008-2010

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    jiang zefei, Ph.D
    Organizational Affiliation
    Academy MMS,China
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    34037241
    Citation
    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.
    Results Reference
    derived
    PubMed Identifier
    33084020
    Citation
    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.
    Results Reference
    derived

    Learn more about this trial

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

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