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

Not Applicable

Recruiting

• Conditions: Circulating Tumor Cell; Breast Cancer
• Interventions: Device: GILUPI CellCollector®

• Registration Number: NCT05360290
• Lead Sponsor: RenJi Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-04-23
• Study First Submitted QC: 2022-04-29
• Study First Posted: 2022-05-04
• Study Start: 2022-09-14
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-18
• Last Update Posted: 2023-11-21
• Primary Completion: 2024-05
• Study Completion: 2029-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 484

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CTC positive	GILUPI CellCollector®	-
CTC negative	GILUPI CellCollector®	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
pathological complete response (pCR)	at surgery	ypT0 ypN0, ypT0/is ypN0, ypT0 or ypT0/is

Trial Locations

Locations (1)

Renji Hospital, School of Medicine, Shanghai Jiao Tong University; 🇨🇳 Shanghai, Shanghai, China