ClinicalTrials.gg
RecruitingNCT05360290CTCNeoBC-EUpdated Feb 3, 2026

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

An interventional study of GILUPI CellCollector® in Breast Cancer and Circulating Tumor Cell, sponsored by RenJi Hospital. Recruiting at 1 site in China. Open to female participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-02-03.

Sponsored by RenJi Hospital · Not applicable, Interventional, and Screening

From the registry’s dates

  • Primary completion was expected by Jun 2026, 5 months ago, but the record still lists the study as recruiting.
  • Started Sep 2022; still recruiting 4 years 1 month later.
Phase
Not applicable
Study type
Interventional
Enrollment
484
Allocation
Non-randomized
Ages
18 Years to 70 Years
Sex
Female
01

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.

02

Conditions studied

  • Breast Cancer
  • Circulating Tumor Cell
03

In context

Breast Neoplasms

14,825 studies on the registry are indexed under Breast Neoplasms; 3,319 are open to participants now.

This study's planned enrollment of 484 is above the median of 72 across 10,896 interventional studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

RenJi Hospital is the lead sponsor of 550 studies on the registry; 247 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • disease (Stage IV);
  • Female patients who are pregnancy or lactation;
  • Uncontrollable puncture site infection or systemic infection;
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

Adjuvant and neoadjuvant

Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

05

Study design

Phase
Not applicable
Primary purpose
Screening
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
484 participants (estimated)

Study arms

  • Active comparator
    CTC positive

    Device: GILUPI CellCollector®

  • Other
    CTC negative

    Device: GILUPI CellCollector®

Interventions

  • DeviceGILUPI CellCollector®

    Use of GILUPI CellCollector® to detect CTC

06

What researchers measure

Primary outcomes

  1. invasive disease-free survival (iDFS)

    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.

    Time frame: From surgery until time of event up to 3 years

Secondary outcomes

  1. pathological complete response (pCR)

    ypT0 ypN0, ypT0/is ypN0, ypT0 or ypT0/is

    Time frame: at surgery

  2. overall Survival (OS)

    Overall survival is defined as the time from randomization to death from any cause.

    Time frame: From surgery until time of event up to 3 years

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 3, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05360290
Lead sponsor
RenJi Hospital
Responsible party
Wenjin Yin (Deputy Chief of Breast Surgery Department, RenJi Hospital) — Principal investigator
First posted
May 4, 2022
Start date
Sep 14, 2022
Primary completion
Jun 2026 (estimated)
Completion
Jun 2029 (estimated)
Last update
Feb 3, 2026

Study contacts

Wenji Yin
Contact
followroad@163.com
86(21)68385569
Qi Lu
Contact
rjllb3364@163.com
86(21)68383364

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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