This study aims to evaluate the efficacy and safety of capecitabine as the only adjuvant chemotherapy drug in patients with low-risk early triple-negative breast cancer who have received adequate local treatment. Patients meeting the inclusion criteria will receive capecitabine metronomic therapy for one year.
This study aims to evaluate the efficacy and safety of capecitabine as the only adjuvant chemotherapy drug in patients with low-risk T1N0M0 early triple-negative breast cancer who have received adequate local treatment. Patients meeting the inclusion criteria will receive capecitabine metronomic therapy for one year. The low-risk population defined in this study includes the IM subtype with abundant stromal tumor-infiltrating lymphocytes, or the LAR subtype with low ki-67 proliferation, or elderly patients.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
198
Capecitabine 650mg/m2, bid, p.o for 1 year
breast cancer institute of Fudan University Cancer Hospital
Shanghai, Shanghai Municipality, China
RFS
recurrence free survival
Time frame: 3 years
iDFS
invasive disease-free survival
Time frame: 3 years
DRFS
distant relapse-free survival
Time frame: 3 years
DFS
disease-free survival
Time frame: 3 years
OS
overall survival
Time frame: 3 years
adverse events
adverse events according to CTCAE 5.0
Time frame: 3 years
PRO
patient reported outcome
Time frame: 3 years
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