CTCs in Breast Cancer After Neoadjuvant Treatment and Surgery: a Multicenter, Prospective Clinical Trial

Phase

N/A

Condition

Breast Cancer

Cancer

Treatment

GILUPI CellCollector®

Clinical Study ID

NCT05360290

KY2022-044-B

Ages 18-70
Female

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Female, aged ≥18 and ≤70 years;
Histologically confirmed invasive breast cancer (cT2-4N0-2M0 or cT1N1-3M0 beforeneoadjuvant treatment);
Completed neoadjuvant treamtment and surgery (within 4 years after surgery);
Administered neoadjuvant chemotherapy (regardless of chemotherapy regimen);
ECOG 0-1

Exclusion

Exclusion Criteria:

Metastatic disease (Stage IV);
Female patients who are pregnancy or lactation;
Uncontrollable puncture site infection or systemic infection;

Study Design