Early triple negative breast cancer patients who do not achieve pathologic complete response after neoadjuvant chemotherapy with or without immunotherapy have bad prognosis. ctDNA effectively identified patients with highest relapse risk. This trial aims to explore whether the combination of anlotinib, immunotherapy and capecitabine could improve the outcome of this subgroup of high relapse risk patients compared with investigator's choice of therapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
411
Anlotinib 8mg qd PO，357days
Benmelstobart 200mg i.v. Q3W
Capecitabine 1000 or 1250 mg/m2 BID day1-14
Sun Yat-sen Memorial Hospital
Guangzhou, Guangodng, China
RECRUITINGiDFS
invasive disease free survival
Time frame: from randomization to any of the following events: local or distant relapse; contralateral breast caner, death of any cause，assessed up to 36 months.
dDFS
distant disease free survival
Time frame: from randomization to any of the following events: distant relapse; contralateral breast caner, death of any cause，assessed up to 36 months
OS
overall survival
Time frame: from randomization to any of the following events: death of any cause，assessed up to 120 months
ctDNA clearance
the rate of patients whose ctDNA are positive after surgery and turns negative after boost therapy
Time frame: From the time when post-operative ctDNA is tested to be positive to the time surveillence ctDNA turns negative, assessed up to 60 months
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