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

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Chinese Multi-Center,Randomized Study of Combination or Sequential Use of Docetaxel,Anthracycline and Cyclophosphamide in Adjuvant Therapy for Node Positive Breast Cancer

Conditions
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Breast Neoplasms, Adjuvant, Chemotherapy

Intervention / Treatment
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* Drug: Docetaxel, Doxorubicin or Epirubicin, Cyclophosphamide
* Drug: Docetaxel, Doxorubicin or Epirubicin, Cyclophosphamide


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>six cycles of adjuvant TAC | Drug: Docetaxel, Doxorubicin or Epirubicin, Cyclophosphamide<br>* Docetaxel 75mg/m2, doxorubicin 50mg/m2 or epirubicin 60mg/m2, cyclophosphamide 500mg/m2 six cycles<br>* Other names: Docetaxel=Taxotere®;|
| Experimental: B<br>four cycles of T followed by 4 cycles of AC | Drug: Docetaxel, Doxorubicin or Epirubicin, Cyclophosphamide<br>* Docetaxel 100mg/m2 four cycles; Doxorubicin 60mg/m2 or epirubicin 75mg/m2 ,cyclophosphamide 600mg/m2) four cycles<br>* Other names: Docetaxel= Taxotere®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease Free Survival |  | 5 years and 10 years | 
| Grade III/IV Adverse Event,Severe Adverse Event |  | during chemotherapy and 30 days after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival |  | 5 years and 10 years | 
| Distant disease free Survival |  | 5 years and 10 years | 
| Time to treatment failure |  | 5 years and 10 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast-adjuvant, Breast-chemotherapy, Combination chemotherapy regimens