Breast Neoplasms Clinical Trial
Official title:
A Phase III Randomized Study of Sequential Epidoxorubicin Followed By CMF: Cyclophosphamide+Methotrexate+Fluorouracil (Arm A) Versus Sequential Epidoxorubicin Followed By Docetaxel Followed By CMF (Arm B) Versus Sequential Intensified Epidoxorubicin Followed By Docetaxel Followed By High-Dose Cyclophosphamide (Arm C) in Early Breast Cancer Patients With Positive Axillary Lymph Nodes
Primary objectives:
- To compare the disease free survival (DFS) in patients treated with the sequential
epidoxorubicin, cyclophosphamide, methotrexate, and fluorouracil (CMF) regimen to that
in patients treated with the same treatment plus docetaxel given sequentially after
epidoxorubicin
Secondary objectives:
- To compare the DFS in patients treated with the sequential epidoxorubicin, docetaxel
and CMF (only patients with > or = 4 lymph nodes) regimen to that in patients treated
with sequential intensified epidoxorubicin/docetaxel/high dose (HD) cyclophosphamide
regimen
- To evaluate the overall survival in each arm
- To evaluate the tolerability of a sequential intensified
epidoxorubicin/docetaxel/HD-cyclophosphamide (arm C)
- To compare the safety of a sequential epidoxorubicin/docetaxel/CMF (arm B) regimen
versus a standard sequential epidoxorubicin/CMF regimen (arm A)
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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