The GILUPI CellCollector® is the first in vivo CTC isolation product worldwide, which is CE approved. This is a prospective, multicenter study to evaluate the prognostic value of circulating tumor cells in breast cancer patients who completed surgery after neoadjuvant treatment.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
SCREENING
Masking
NONE
Enrollment
484
Use of GILUPI CellCollector® to detect CTC
Renji Hospital, School of Medicine, Shanghai Jiao Tong University
Shanghai, Shanghai Municipality, China
RECRUITINGinvasive disease-free survival (iDFS)
Invasive disease-free survival time is defined as the time from date of randomization until the first occurrence of invasive disease recurrence, distant metastasis and death from any cause.
Time frame: From surgery until time of event up to 3 years
pathological complete response (pCR)
ypT0 ypN0, ypT0/is ypN0, ypT0 or ypT0/is
Time frame: at surgery
overall Survival (OS)
Overall survival is defined as the time from randomization to death from any cause.
Time frame: From surgery until time of event up to 3 years
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