Breast Cancer, Circulating Tumor Cell
Conditions
Brief summary
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.
Interventions
DEVICEGILUPI CellCollector®
Use of GILUPI CellCollector® to detect CTC
Sponsors
RenJi Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Female, aged ≥18 and ≤70 years; * Histologically confirmed invasive breast cancer (cT2-4N0-2M0 or cT1N1-3M0 before neoadjuvant treatment); * Completed neoadjuvant treamtment and surgery (within 4 years after surgery); * Administered neoadjuvant chemotherapy (regardless of chemotherapy regimen); * ECOG 0-1
Exclusion criteria
* Metastatic disease (Stage IV); * Female patients who are pregnancy or lactation; * Uncontrollable puncture site infection or systemic infection;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| invasive disease-free survival (iDFS) | From surgery until time of event up to 3 years | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| pathological complete response (pCR) | at surgery | ypT0 ypN0, ypT0/is ypN0, ypT0 or ypT0/is |
| overall Survival (OS) | From surgery until time of event up to 3 years | Overall survival is defined as the time from randomization to death from any cause. |
Countries
China
Contacts
CONTACTWenji Yin
CONTACTQi Lu
Outcome results
None listed