drugset / Trial / NCT00525642

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

NCT00525642

Phase 2/3 Unknown 603 enrolled Fudan University
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2003-06
Primary completion
Completion
2015-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Cyclophosphamide Other / unclassified 500 mg/m2
Subject Cyclophosphamide Other / unclassified 600 mg/m2
Subject Docetaxel Small molecule 75 mg/m2
Subject Docetaxel Small molecule 100 mg/m2
Subject Doxorubicin Other / unclassified 50 mg/m2
Subject Doxorubicin Other / unclassified 60 mg/m2
Subject Epirubicin Small molecule 60 mg/m2
Subject Epirubicin Small molecule 75 mg/m2

Indications