Back to resultsCTCs in Breast Cancer After Neoadjuvant Treatment and Surgery: a Multicenter, Prospective Clinical Trial (CTCNeoBC-E)
Primary Purpose
Breast Cancer, Circulating Tumor Cell
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
GILUPI CellCollector®
Sponsored by
About this trial
This is an interventional screening trial for Breast Cancer
Eligibility Criteria
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;
Sites / Locations
- Renji Hospital, School of Medicine, Shanghai Jiao Tong UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Other
Arm Label
CTC positive
CTC negative
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
pathological complete response (pCR)
ypT0 ypN0, ypT0/is ypN0, ypT0 or ypT0/is
overall Survival (OS)
Overall survival is defined as the time from randomization to death from any cause.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05360290
Brief Title
CTCs in Breast Cancer After Neoadjuvant Treatment and Surgery: a Multicenter, Prospective Clinical Trial
Acronym
CTCNeoBC-E
Official Title
The Value of Circulating Tumor Cells in Patients With Breast Cancer Who Completed Surgery After Neoadjuvant Treatment: a Multicenter, Prospective Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 14, 2022 (Actual)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
June 2029 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
RenJi Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Circulating Tumor Cell
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
484 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
CTC positive
Arm Type
Active Comparator
Arm Title
CTC negative
Arm Type
Other
Intervention Type
Device
Intervention Name(s)
GILUPI CellCollector®
Intervention Description
Use of GILUPI CellCollector® to detect CTC
Primary Outcome Measure Information:
Title
invasive disease-free survival (iDFS)
Description
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 Outcome Measure Information:
Title
pathological complete response (pCR)
Description
ypT0 ypN0, ypT0/is ypN0, ypT0 or ypT0/is
Time Frame
at surgery
Title
overall Survival (OS)
Description
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
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wenji Yin
Phone
86(21)68385569
Email
followroad@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Qi Lu
Phone
86(21)68383364
Email
rjllb3364@163.com
Facility Information:
Facility Name
Renji Hospital, School of Medicine, Shanghai Jiao Tong University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200127
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jinsong Lu, MD
Email
lujjss@163.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
CTCs in Breast Cancer After Neoadjuvant Treatment and Surgery: a Multicenter, Prospective Clinical Trial
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