Breast Cancer
Conditions
Keywords
positive lymph node
Brief summary
To compare the efficacy and safety of EC-T and ET regimen as adjuvant treatment of breast cancer patients with positive lymph nodes
Detailed description
EC-T regimen: epirubicin 90mg/m2 day1, CTX 600mg/m2, day 1, 21 days per cycle \*4cycle. followed by paclitaxel 175mg/m2,d1,21days per cycle, 4 cycle. ET regimen: epirubicin 75mg/m2 day1,paclitaxel 175mg/m2,d2,21days per cycle, 6 cycle
Interventions
DRUGEpirubicin, CTX, Paclitaxel
Epirubicin 90mg/m2 and CTX 600mg/m2 on day1 of each 21-day cycle, 4 cycles; followed by Paclitaxel 175mg/m2 on day1 of each 21-day cycle, 4 cycles.
DRUGEpirubicin, Paclitaxel
Epirubicin 75mg/m2 on day1 and Paclitaxel 175mg/m2 on day2 of each 21-day cycle, 6 cycles.
Sponsors
Chinese Academy of Medical Sciences
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
* patients with breast cancer after breast cancer surgery with positive lymph nodes age 18-70 years old
Exclusion criteria
* with other malignance disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS | 5 years after all the recuiment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| OS | 5 years after all the adjuvent treatments | — |
| Safety | 5 years after all the recruiment | Assessing for Hematology and Non-hematology toxicities, including all SAEs. |
Countries
China
Contacts
Primary ContactPeng Yuan, M.D.
Outcome results
None listed