This is a prospective, single center, randomized, open-labled stage III clinical trial comparing the efficacy and safety of anthracyclin followed by weekly paclitaxel versus dose-dense anthracyclin followed by weekly paclitaxel versus dose-dense anthracyclin followed by weekly paclitaxel combined with carboplatin for high-risk, triple-negative early breast cancer.
This is a prospective, single center, randomized, open-labled stage III clinical trial comparing the efficacy and safety of anthracyclin followed by weekly paclitaxel versus dose-dense anthracyclin followed by weekly paclitaxel versus dose-dense anthracyclin followed by weekly paclitaxel combined with carboplatin for high-risk, triple-negative early breast cancer.High risk is defined as positive lymph nodes or negative lymph nodes but ki-67 is not less than 50%. We aim to explore whether the addition of carboplatin can improve the disease-free survival of early high-risk triple-negative breast cancer. At the same time, the experimental group's anthracyclines must be given in a dose-dense manner, while anthracyclines in the control group are dose-dense or not.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
808
90mg/m2, d1 every 2 or 3 weeks
600mg, d1 every 2 or 3 weeks
80mg/m2,d1,d8,d15, every 3 weeks
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
Disease free survival
Time frame: 3 year
overall survival
Time frame: 3 year
distant disease free survival
Time frame: 3 year
recurrence free survival
Time frame: 3 year
Disease free survival
Time frame: 5 year
overall survival
Time frame: 5 year
recurrence free survival
Time frame: 5 year
distant disease free survival
Time frame: 5 year
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90mg/m2, d1 every 2 weeks
600mg, d1 every 2 weeks
80mg/m2,d1,d8,d15, every 4 weeks
AUC=2,d1,d8,d15, every 4 weeks