Breast CancerCTCNeoBC-ENCT05360290
CTCs in Breast Cancer After Neoadjuvant Treatment and Surgery: a Multicenter, Prospective Clinical Trial
A study testing GILUPI CellCollector® in people with Breast Cancer and Circulating Tumor Cell, run by RenJi Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Breast Cancer, Circulating Tumor Cell
- What is being tested?
- GILUPI CellCollector®
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 484 participants
- Where
- 1 siteChina
- Study dates
- 14 Sep 2022to Jun 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Metastatic disease (Stage IV);
- Female patients who are pregnancy or lactation;
- Uncontrollable puncture site infection or systemic infection;
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Renji Hospital, School of Medicine, Shanghai Jiao Tong University
Shanghai, Shanghai Municipality, 200127
Jinsong Lu, MD, lujjss@163.com
About this study
Official title: 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.
- Conditions
- Breast Cancer, Circulating Tumor Cell
- Being tested
- GILUPI CellCollector®
- Medical subject headings
- Breast Neoplasms, Neoplastic Cells, Circulating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GILUPI CellCollector®Device
Use of GILUPI CellCollector® to detect CTC
| Study group | Role | What they receive |
|---|---|---|
| CTC positive | Active comparator | Not described Receives: Device: GILUPI CellCollector® |
| CTC negative | Other | Not described Receives: Device: GILUPI CellCollector® |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From surgery until time of event up to 3 years
Secondary outcomes (2)
pathological complete response (pCR)
ypT0 ypN0, ypT0/is ypN0, ypT0 or ypT0/is
Measured: at surgery
overall Survival (OS)
Overall survival is defined as the time from randomization to death from any cause.
Measured: From surgery until time of event up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2022
- Study start14 Sep 2022
- Primary completionJun 2026 (estimated)
- Study completionJun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by RenJi HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 484 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wenjin Yin, RenJi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05360290
- Sponsor's protocol ID
- KY2022-044-B
- Acronym
- CTCNeoBC-E
- Status last verified
- Feb 2026
- First submitted
- 23 Apr 2022
- Last updated
- 3 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Value of Circulating Tumor Cells in Patients With Breast Cancer Who Completed Surgery After Neoadjuvant Treatment: a Multicenter, Prospective Clinical Trial
- ClinicalTrials.gov ID
- NCT05360290
- Acronym / sponsor ID
- CTCNeoBC-E / KY2022-044-B
- Conditions
- Breast Cancer, Circulating Tumor Cell
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 484 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- 14 Sep 2022 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2029 (estimated)
- First posted
- 4 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CTC positive | Active comparator | Device: GILUPI CellCollector® |
| CTC negative | Other | Device: GILUPI CellCollector® |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Metastatic disease (Stage IV);
- Female patients who are pregnancy or lactation;
- Uncontrollable puncture site infection or systemic infection;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GILUPI CellCollector®Use of GILUPI CellCollector® to detect CTC | Device | CTC negative, CTC positive |
Primary outcome
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.
2 secondary outcomes
pathological complete response (pCR)
Time frame: at surgery
overall Survival (OS)
Time frame: From surgery until time of event up to 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GILUPI CellCollector® in people with Breast Cancer and Circulating Tumor Cell, run by RenJi Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wenji Yin (86(21)68385569, followroad@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
invasive disease-free survival (iDFS) (time frame: From surgery until time of event up to 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2026.