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

Breast Cancer Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05360290
• Other study ID #: KY2022-044-B
• Status: Recruiting
• Phase: N/A
• Start date: September 14, 2022
• Est. completion date: June 2029

Study information

• Verified date: November 2023
• Source: RenJi Hospital
• Contact: Wenji Yin
• Phone: 86(21)68385569
• Email: followroad[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 484
• Est. completion date: June 2029
• Est. primary completion date: May 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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;

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Circulating Tumor Cell
• Neoplastic Cells, Circulating

Intervention

Device:
• GILUPI CellCollector®
Use of GILUPI CellCollector® to detect CTC

Locations

Country	Name	City	State
China	Renji Hospital, School of Medicine, Shanghai Jiao Tong University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
RenJi Hospital

Country where clinical trial is conducted

China, 

Outcome

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