Although there is a certain risk of recurrence of HER2-positive small tumors, the overall prognosis is relatively good. In order to further reduce the toxicity and side effects of treatment and explore the best strategy for adjuvant therapy in patients with HER2-positive stage IA breast cancer, we designed this phase III, randomized, open-label study to evaluate the efficacy and safety of paclitaxel plus trastuzumab and capecitabine versus paclitaxel plus trastuzumab in the adjuvant treatment of patients with HER2-positive, node-negative breast cancer.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
2,306
capecitabine (1000-1250mg/m2, orally, bid, D1-14, q3w) and trastuzumab (first dose 8mg/kg, q3w; Follow-up maintenance 6 mg/kg, q3w, subcutaneous or intravenous for 1 year)
paclitaxel (80mg/m2, qw, D1, 8, 15, intravenous, q3w) trastuzumab (first dose 8mg/kg, q3w; Follow-up maintenance 6mg/kg, q3w, subcutaneous or intravenous for 1 year)
Fudan University Shanghai Cancer Center Shanghai, China, 200032
Shanghai, Shanghai Municipality, China
RECRUITINGiDFS
invasive disease-free survival
Time frame: 5 years
DDFS
distant disease-free survival
Time frame: 5 years
OS
overall survival
Time frame: 5 years
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