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 – 70 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: 2026-11-12.