A Phase 2/3 interventional study of Docetaxel, Doxorubicin or Epirubicin, Cyclophosphamide and Docetaxel, Doxorubicin or Epirubicin, Cyclophosphamide in Breast Neoplasms, Adjuvant and Chemotherapy, sponsored by Fudan University. Status unknown at 5 sites in China. Open to female participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2007-09-06.
Sponsored by Fudan University · Phase 2/3, Interventional, and Treatment
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.
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.
12,543 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 603 is above the median of 72 across 9,302 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Fudan University is the lead sponsor of 1,270 studies on the registry; 623 are open to participants now.
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Exclusion Criteria:
six cycles of adjuvant TAC
Drug: Docetaxel, Doxorubicin or Epirubicin, Cyclophosphamide
four cycles of T followed by 4 cycles of AC
Drug: Docetaxel, Doxorubicin or Epirubicin, Cyclophosphamide
Docetaxel 75mg/m2, doxorubicin 50mg/m2 or epirubicin 60mg/m2, cyclophosphamide 500mg/m2 six cycles
Also known as: Docetaxel=Taxotere®
Docetaxel 100mg/m2 four cycles; Doxorubicin 60mg/m2 or epirubicin 75mg/m2 ,cyclophosphamide 600mg/m2) four cycles
Also known as: Docetaxel= Taxotere®
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
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
This study is status unknown, as verified in Aug 2007. You cannot join it, but the record below documents what was studied.
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Fudan University