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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by:
Fudan University
ClinicalTrials.gov Identifier:
NCT00525642
First received: September 4, 2007
Last updated: NA
Last verified: August 2007
History: No changes posted

September 4, 2007
September 4, 2007
June 2003
Not Provided
  • 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 ]
Same as current
No Changes Posted
  • 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 ]
Same as current
Not Provided
Not Provided
 
Study of Suitable Schedule of Docetaxel,Anthracycline and Cyclophosphamide in Adjuvant Therapy of Beast Cancer
A Chinese Multi-Center,Randomized Study of Combination or Sequential Use of Docetaxel,Anthracycline and Cyclophosphamide in Adjuvant Therapy for Node Positive Breast Cancer

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.

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.

Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Breast Neoplasms
  • Adjuvant
  • Chemotherapy
  • 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®
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
603
June 2015
Not Provided

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
Female
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT00525642
TAX-619
Yes
Not Provided
Fudan University
Not Provided
Study Chair: Zhenzhou Shen, M.D. Cancer Hospital / Institute, Fudan University
Study Director: Zhiming Shao, M.D. Cancer Hospital / Institute, Fudan University
Fudan University
August 2007

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