Recruiting
CTCs in Breast Cancer After Neoadjuvant Treatment and Surgery: a Multicenter, Prospective Clinical Trial
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.
ClinicalTrials.gov IDNCT05360290
PhaseNA
Enrollment484
SponsorRenJi Hospital
Age18 Years
SexFEMALE
Conditions studied
Breast Cancer, Circulating Tumor Cell
About this study
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
- Device: GILUPI CellCollector® — Use of GILUPI CellCollector® to detect CTC
Primary outcomes
- invasive disease-free survival (iDFS) (From surgery until time of event up to 3 years)
Eligibility information
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;
Study locations
- Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, Shanghai Municipality 200127 China
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.