This trial is a multicenter, single-arm clinical trial to evaluate the efficacy and safety of UTD1 in combination with capecitabine for the adjuvant treatment of TNBC patients who did not achieve pathologic complete remission after neoadjuvant therapy. TNBC patients who did not achieve pathological complete remission or positive lymph node after neoadjuvant chemotherapy received adjuvant treatment with study drug. Solution: UTD1 30mg / m², once a day on days 1-5; capecitabine: 1000mg / m², days 1-14, oral, twice / day; 21 days a treatment cycle of 6-8 cycles.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
53
UTD1: 30mg / m², once a day on days 1-5; capecitabine: 1000mg / m², days 1-14, oral, twice / day; 21 days a treatment cycle of 6-8 cycles.
Quchang Ouyang
Changsha, Hunan, China
RECRUITING2-year disease-free survival (DFS)
2-year DFS will be defined as the percentage of patients alive without recurrence or metastasis of disease at 2 years measured from the date of enrollment.
Time frame: 2 years
Overall Survival (OS)
OS was calculated for each patient based on time of enrollment to time of death.
Time frame: Up to 2 years (from date of enrollment to the date of death).
Disease Free Survival (DFS)
DFS was measured from surgery to the time of recurrence or metastasis.
Time frame: Up to 2 years (from date of surgery to the date of recurrence / metastasis).
Invasive Disease free survival (iDFS)
iDFS was measured from surgery to the time of invasive local, axillary or distant recurrence, invasive contralateral breast cancer or death from any cause (whichever occurs first).
Time frame: From the date of surgery to the time of invasive local, axillary or distant recurrence, invasive contralateral breast cancer or death from any cause (whichever occurs first)., up to 2 years.
Distant Disease-free Survival (DDFS)
DDFS is defined as the time from surgery to distant recurrence, or death due to any cause.
Time frame: From the date of surgery to distant recurrence, or death due to any cause (up to 2 years).
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