Overview

This trial is active, not recruiting.

Conditions breast neoplasms, adjuvant, chemotherapy
Treatments docetaxel, doxorubicin or epirubicin, cyclophosphamide
Phase phase 2/phase 3
Sponsor Fudan University
Start date June 2003
End date June 2015
Trial size 603 participants
Trial identifier NCT00525642, TAX-619

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
six cycles of adjuvant TAC
docetaxel, doxorubicin or epirubicin, cyclophosphamide Docetaxel=Taxotere®
Docetaxel 75mg/m2, doxorubicin 50mg/m2 or epirubicin 60mg/m2, cyclophosphamide 500mg/m2 six cycles
(Experimental)
four cycles of T followed by 4 cycles of AC
docetaxel, doxorubicin or epirubicin, cyclophosphamide Docetaxel= Taxotere®
Docetaxel 100mg/m2 four cycles; Doxorubicin 60mg/m2 or epirubicin 75mg/m2 ,cyclophosphamide 600mg/m2) four cycles

Primary Outcomes

Measure
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

Secondary Outcomes

Measure
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

Eligibility Criteria

Female participants from 18 years up to 70 years old.

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

Additional Information

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
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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2007.
Information provided to ClinicalTrials.gov by Fudan University.