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

Sponsor

Fudan University (Other)

Overall Status

Unknown status

CT.gov ID

NCT00525642

Collaborator

(none)

603

Enrollment

Locations

Arms

144

Duration (Months)

120.6

Patients Per Site

0.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Neoplasms Adjuvant Chemotherapy	Drug: Docetaxel, Doxorubicin or Epirubicin, Cyclophosphamide Drug: Docetaxel, Doxorubicin or Epirubicin, Cyclophosphamide	Phase 2/Phase 3

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 Design

Study Type:

Interventional

Actual Enrollment :

603 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jun 1, 2003

Anticipated Study Completion Date :

Jun 1, 2015

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: A

six cycles of adjuvant TAC

Drug: Docetaxel, Doxorubicin or Epirubicin, Cyclophosphamide

Docetaxel 75mg/m2, doxorubicin 50mg/m2 or epirubicin 60mg/m2, cyclophosphamide 500mg/m2 six cycles

Other Names:

Docetaxel=Taxotere®

Experimental: B

four cycles of T followed by 4 cycles of AC

Drug: Docetaxel, Doxorubicin or Epirubicin, Cyclophosphamide

Docetaxel 100mg/m2 four cycles; Doxorubicin 60mg/m2 or epirubicin 75mg/m2 ,cyclophosphamide 600mg/m2) four cycles

Other Names:

Docetaxel= Taxotere®

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Beijing 307 Hospital	Beijing	Beijing	China
2	No2 affiliated hospital of Sun Yat-sen medical Univesity	Guangzhou	Guangdong	China
3	Liaoning Province Cancer Hospital	Shenyang	Liaoning	China
4	Cancer Hospital / Institute, Fudan University	Shanghai	Shanghai	China	200032
5	Shanghai No.6 hospital	Shanghai	Shanghai	China

Sponsors and Collaborators

Fudan University

Investigators

Study Chair: Zhenzhou Shen, M.D., Cancer Hospital / Institute, Fudan University
Study Director: Zhiming Shao, M.D., Cancer Hospital / Institute, Fudan University