CTCs in Breast Cancer After Neoadjuvant Treatment and Surgery: a Multicenter, Prospective Clinical Trial (CTCNeoBC-E)

February 1, 2026 updated by: Wenjin Yin, RenJi Hospital

The Value of Circulating Tumor Cells in Patients With Breast Cancer Who Completed Surgery After Neoadjuvant Treatment: 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

484

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200127
        • Recruiting
        • Renji Hospital, School of Medicine, Shanghai Jiao Tong University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: CTC positive
Device: GILUPI CellCollector®
Use of GILUPI CellCollector® to detect CTC
Other: CTC negative
Device: GILUPI CellCollector®
Use of GILUPI CellCollector® to detect CTC

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
invasive disease-free survival (iDFS)
Time Frame: 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.
From surgery until time of event up to 3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pathological complete response (pCR)
Time Frame: at surgery
ypT0 ypN0, ypT0/is ypN0, ypT0 or ypT0/is
at surgery
overall Survival (OS)
Time Frame: From surgery until time of event up to 3 years
Overall survival is defined as the time from randomization to death from any cause.
From surgery until time of event up to 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

RenJi Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 14, 2022

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2029

Study Registration Dates

First Submitted

April 23, 2022

First Submitted That Met QC Criteria

April 29, 2022

First Posted (Actual)

May 4, 2022

Study Record Updates

Last Update Posted (Actual)

February 3, 2026

Last Update Submitted That Met QC Criteria

February 1, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KY2022-044-B

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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