This is a prospective, randomized, open-lable phase III clinical trial evaluating the effectiveness and safety of vinorelbine plus capecitabine as adjuvant treatment for non-pCR Luminal B breast cancer patients after standard neoadjuvant chemotherapy.
This is a prospective ,randomized, open-lable phase III clinical trial evaluating the effectiveness and safety of vinorelbine plus capecitabine as adjuvant treatment for non-pCR Luminal B breast cancer patients after standard neoadjuvant chemotherapy. Non-pCR Luminal B patients who completed 6-8 cycles of standard neoadjuvant chemotherapy will be included in this study and receive 4 cycles of NX regimen chemotherapy for 4 cycles (vinorelbine 25 mg/m² d1,8 and capecitabine 1250 mg/m² d1-14, every 3 weeks) or not. the investigator's primary endpoint is disease free survival (DFS). Secondary end points include overall survival (OS), recurrence free survival (RFS), distant disease free survival (DDFS)rates and safety.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
316
Oral capecitabine (at a dose of 1250 mg/m², twice per day, on days 1 to 14) every 3 weeks for 4 cycles.
Intravenous vinorelbine (at a dose of 25 mg/m² on day 1, day 8) every 3 weeks for 4 cycles.
Cancer Hospital/ Institute, Fudan University
Shanghai, Shanghai Municipality, China
RECRUITINGDisease free survival
The length of time after primary treatment for a cancer ends that the patient survives without any signs or symptoms of that cancer
Time frame: 5-year
Overall survival
Overall survival is calculated from randomization to death from any cause.
Time frame: 5-year
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