Circulating tumor DNA (ctDNA) has been demonstrated to be an effective prognostic marker in breast cancer. Various studies have shown that early TNBC breast cancer patients with positive ctDNA have high risk of cancer recurrence and worse prognosis. This study aimed to identify TNBC patients with positive ctDNA and initiate boost therapy in these high risk patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
260
capecitabine is proved to improve 5-year disease-free survival among women with early-stage triple-negative breast cancer who received standard adjuvant treatment(The SYSUCC-001 Randomized Clinical Trial)
Camrelizumab combined with apatinib is a safe and effective combination proved in patients with advanced TNBC in our early study
Sunyat-sen Memorial Hospital
Guandong, Guangdong, China
RECRUITINGInvasive Disease Free Survival(IDFS)
Invasive Disease-Free Survival for capecitabine versus capecitabine + apatinib + camrelizumab in ctDNA-positive stage II-III TNBC patients, using STEEP criteria
Time frame: 60 months
Distant disease-free survival(DDFS)
Distant Disease-Free Survival for capecitabine versus capecitabine + apatinib + camrelizumab in ctDNA-positive stage II-III TNBC patients, using STEEP criteria
Time frame: 60 months
Overall Survival
Overall Survival for capecitabine versus capecitabine + apatinib + camrelizumab in ctDNA-positive stage II-III TNBC patients, using STEEP criteria
Time frame: 60 months
Brain metastasis rate
Brain metastasis rate for capecitabine versus capecitabine + apatinib + camrelizumab in ctDNA-positive stage II-III TNBC patients, using STEEP criteria
Time frame: 60 months
The rate of adverse effects(AEs)
AEs related to apatinib and/or camrelizumab
Time frame: 60 months
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