Adjuvant, Breast Neoplasms, Chemotherapy
Conditions
Keywords
Breast-adjuvant, Breast-chemotherapy, Combination chemotherapy regimens
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.
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.
Interventions
DRUGDocetaxel, Doxorubicin or Epirubicin, Cyclophosphamide
Docetaxel 75mg/m2, doxorubicin 50mg/m2 or epirubicin 60mg/m2, cyclophosphamide 500mg/m2 six cycles
Sponsors
Fudan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | 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 |
Countries
China
Outcome results
None listed