A Chinese Multi-Center,Randomized Study of Combination or Sequential Use of Docetaxel,Anthracycline and Cyclophosphamide in Adjuvant Therapy for Node Positive Breast Cancer
18 Years
70 Years
Female
Breast Neoplasms, Adjuvant, Chemotherapy
Trial Information
A Chinese Multi-Center,Randomized Study of Combination or Sequential Use of Docetaxel,Anthracycline and Cyclophosphamide in Adjuvant Therapy for Node Positive Breast Cancer
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Disease Free Survival
Outcome Time Frame:
5 years and 10 years
Principal Investigator
Zhenzhou Shen, M.D.
Investigator Role:
Study Chair
Investigator Affiliation:
Cancer Hospital / Institute, Fudan University
Authority:
China:Chinese Breast Cancer Society,Chinese Anti-Cancer Association
Study ID:
TAX-619
NCT ID:
NCT00525642
Start Date:
June 2003
Completion Date:
June 2015
Related Keywords:
- Breast Neoplasms
- Adjuvant
- Chemotherapy
- Breast-adjuvant
- Breast-chemotherapy
- Combination chemotherapy regimens
- Breast Neoplasms
- Neoplasms
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