A Phase 2 interventional study of Capecitabine in Breast Cancer, sponsored by Fudan University. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-28.
Sponsored by Fudan University · Phase 2, Interventional, and Treatment
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.
8)The patient voluntarily joined the study, signed the informed consent form, had good compliance, and cooperated with the follow-up.
Exclusion Criteria:
capecitabine metronomic therapy for one year
Drug: Capecitabine
Capecitabine 650mg/m2, bid, p.o for 1 year
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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Fudan University