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Study of Suitable Schedule of Docetaxel,Anthracycline and Cyclophosphamide in Adjuvant Therapy of Beast Cancer

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ClinicalTrials.gov Identifier: NCT00525642
Recruitment Status : Unknown
Verified August 2007 by Fudan University.
Recruitment status was:  Active, not recruiting
First Posted : September 6, 2007
Last Update Posted : September 6, 2007
Sponsor:
Information provided by:
Fudan University

Tracking Information
First Submitted Date  ICMJE September 4, 2007
First Posted Date  ICMJE September 6, 2007
Last Update Posted Date September 6, 2007
Study Start Date  ICMJE June 2003
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: September 4, 2007)
  • Disease Free Survival [ Time Frame: 5 years and 10 years ]
  • Grade III/IV Adverse Event,Severe Adverse Event [ Time Frame: during chemotherapy and 30 days after treatment ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: September 4, 2007)
  • Overall Survival [ Time Frame: 5 years and 10 years ]
  • Distant disease free Survival [ Time Frame: 5 years and 10 years ]
  • Time to treatment failure [ Time Frame: 5 years and 10 years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Suitable Schedule of Docetaxel,Anthracycline and Cyclophosphamide in Adjuvant Therapy of Beast Cancer
Official Title  ICMJE A Chinese Multi-Center,Randomized Study of Combination or Sequential Use of Docetaxel,Anthracycline and Cyclophosphamide in Adjuvant Therapy for Node Positive Breast Cancer
Brief Summary Anthracycline based regimens followed by a taxane (CALGB-9344 trial and NSABP-B28) or reversed (MD Anderson Adjuvant Trial) has already accepted as adjuvant therapy for node positive breast cancer. Also in this group of patients, data from BCIRG-001 trial had shown that six cycles of adjuvant TAC (docetaxel, doxorubicin and cyclophosphamide) is superior to standard FAC (5-FU, doxorubicin and cyclophosphamide ) combination in terms of both disease free and overall survival, while associated with a higher rate of febrile neutropenia. Then question arose whether it is better to use docetaxel and anthracycline in combination or sequence.
Detailed Description In this national wide study, women with node positive operable breast cancer are eligible for inclusion.Patients were designed to randomize to six cycles of adjuvant TAC (Taxotere® 75mg/m2, doxorubicin 50mg/m2 or epirubicin 60mg/m2, cyclophosphamide 500mg/m2), and four cycles of T(100mg/m2), followed by 4 cycles of AC(doxorubicin 60mg/m2 or epirubicin 75mg/m2 ,cyclophosphamide 600mg/m2). Prophylaxis with G-CSF was allowed for two arms when febrile neutropenia occurred in the first cycle of the study treatment. The second endpoint of this study is disease free survival. The primary objective is to compare the disease free survival rate and safety profiles of the above mentioned two arms.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Breast Neoplasms
  • Adjuvant
  • Chemotherapy
Intervention  ICMJE
  • Drug: Docetaxel, Doxorubicin or Epirubicin, Cyclophosphamide
    Docetaxel 75mg/m2, doxorubicin 50mg/m2 or epirubicin 60mg/m2, cyclophosphamide 500mg/m2 six cycles
    Other Name: Docetaxel=Taxotere®
  • Drug: Docetaxel, Doxorubicin or Epirubicin, Cyclophosphamide
    Docetaxel 100mg/m2 four cycles; Doxorubicin 60mg/m2 or epirubicin 75mg/m2 ,cyclophosphamide 600mg/m2) four cycles
    Other Name: Docetaxel= Taxotere®
Study Arms  ICMJE
  • Experimental: A
    six cycles of adjuvant TAC
    Intervention: Drug: Docetaxel, Doxorubicin or Epirubicin, Cyclophosphamide
  • Experimental: B
    four cycles of T followed by 4 cycles of AC
    Intervention: Drug: Docetaxel, Doxorubicin or Epirubicin, Cyclophosphamide
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Actual Enrollment  ICMJE
 (submitted: September 4, 2007)
603
Original Actual Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2015
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • pT1-3,pN1-3,M0, operable breast cancer
  • Karnofsky >=80
  • Pregnant test negative

Exclusion Criteria:

  • Prior Chemotherapy with anthracyclines and / or Taxanes, except for Neoadjuvant therapy
  • Prior breast radiation
  • Bilateral breast cancer
  • in-operable breast cancer
  • Other health condition which may be contraindications for chemotherapy
  • contraindications for Dexamethasone
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00525642
Other Study ID Numbers  ICMJE TAX-619
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Fudan University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Zhenzhou Shen, M.D. Cancer Hospital / Institute, Fudan University
Study Director: Zhiming Shao, M.D. Cancer Hospital / Institute, Fudan University
PRS Account Fudan University
Verification Date August 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP