Randomized Phase II Trial of Dose Dense Docetaxel in N+ Breast Cancer
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To screen a dose-dense arm to be used in a future large scale phase III trial. Primary endpoint is safety; secondary endpoints are disease free survival and overall survival. A total of 100 patients were included.
Condition or disease
Node Positive Breast Cancer
Procedure: 6 TEC q 3 weeksProcedure: 4 EC q 2 weeks followed by 4 TXT q 2 weeksProcedure: 4 TXT q 2 weeks followed by 4 EC q 2 weeks
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Ages Eligible for Study:
18 Years and older (Adult, Senior)
Sexes Eligible for Study:
Patient with histologically proven breast cancer
Surgical resection performed with clear margins (R0 resection)
At least 1 histologically proven involved axillary node
ER + or ER-
Interval between surgery (2nd surgical procedure in case of multiple procedures) and randomization inferior to 60 days
Aged over 18 years, and more than 10-year life expectancy
ECOG performance status 0-1
Signed informed consent form prior to randomization
Bilateral breast cancer
Inflammatory breast cancer
Personal history of breast cancer
Immunohistochemical only node involvement
Intraductal breast cancer
Contraindication to any drug contained in the chemotherapy regimens
Any serious active disease or co-morbid medical condition including recent history of severe sepsis and digestive inflammatory disease