CTCs in Breast Cancer After Neoadjuvant Treatment and Surgery: a Multicenter, Prospective Clinical Trial
CTCNeoBC-E
The Value of Circulating Tumor Cells in Patients With Breast Cancer Who Completed Surgery After Neoadjuvant Treatment: a Multicenter, Prospective Clinical Trial
1 other identifier
interventional
484
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable breast-cancer
Started Sep 2022
Longer than P75 for not_applicable breast-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 23, 2022
CompletedFirst Posted
Study publicly available on registry
May 4, 2022
CompletedStudy Start
First participant enrolled
September 14, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2029
February 3, 2026
February 1, 2026
3.7 years
April 23, 2022
February 1, 2026
Conditions
Outcome Measures
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.
From surgery until time of event up to 3 years
Secondary Outcomes (2)
pathological complete response (pCR)
at surgery
overall Survival (OS)
From surgery until time of event up to 3 years
Study Arms (2)
CTC positive
ACTIVE COMPARATORCTC negative
OTHERInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Metastatic disease (Stage IV);
- Female patients who are pregnancy or lactation;
- Uncontrollable puncture site infection or systemic infection;
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- RenJi Hospitallead
Study Sites (1)
Renji Hospital, School of Medicine, Shanghai Jiao Tong University
Shanghai, Shanghai Municipality, 200127, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Deputy Chief of Breast Surgery Department
Study Record Dates
First Submitted
April 23, 2022
First Posted
May 4, 2022
Study Start
September 14, 2022
Primary Completion (Estimated)
June 1, 2026
Study Completion (Estimated)
June 1, 2029
Last Updated
February 3, 2026
Record last verified: 2026-02