Back to results

CTC in Predicting Neoadjuvant Chemotherapy Among LABC Patients: a Single-center, Prospective, Exploratory Clinical Trial (CTCNeoBC)

Primary Purpose

Locally Advanced Breast Cancer, Circulating Tumor Cell

Status

Completed

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

GILUPI CellCollector®

About this trial

This is an interventional treatment trial for Locally Advanced Breast Cancer

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

Patients with histologically confirmed primary invasive breast adenocarcinoma, anatomic stage T2-4N0-3M0 or T1N1-3M0 before neoadjuvant chemotherapy
ECOG 0-1
Adequate organ function
Consent to undergo CTC analysis in vivo

Exclusion Criteria:

Pregnant or breastfeeding patients
Metastatic or recurrent patients
Uncontrollable infection

Sites / Locations

Renji Hospital, School of Medicine, Shanghai Jiao Tong University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

GILUPI CellCollector®

Arm Description

Outcomes

Primary Outcome Measures

Predictive value of CTC in ypT0 ypN0

Secondary Outcome Measures

Predictive value of CTC in ypT0, ypT0/is ypN0, near pCR

hypersensitivity

Number of participants with hypersensitivity as assessed by CTCAE v4.0

Detection rate of GILUPI CellCollector®

Full Information

NCT ID

NCT03732339

First Posted

October 8, 2018

Last Updated

April 23, 2022

Sponsor

RenJi Hospital

Collaborators

Beijing Viroad Biotechnology Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT03732339

Brief Title

CTC in Predicting Neoadjuvant Chemotherapy Among LABC Patients: a Single-center, Prospective, Exploratory Clinical Trial

Acronym

CTCNeoBC

Official Title

Predictive Value of Circulating Tumor Cells in Neoadjuvant Chemotherapy Among Locally Advanced Breast Cancer Patients: a Single-center, Prospective, Exploratory Clinical Trial

Study Type

Interventional

2. Study Status

Record Verification Date

April 2022

Overall Recruitment Status

Completed

Study Start Date

August 24, 2018 (Actual)

Primary Completion Date

March 11, 2019 (Actual)

Study Completion Date

June 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

RenJi Hospital

Collaborators

Beijing Viroad Biotechnology Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

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. The purpose of this clinical trial is to evaluate the predictive value of CTC in neoadjuvant chemotherapy among locally advanced breast cancer patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Locally Advanced Breast Cancer, Circulating Tumor Cell

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

29 (Actual)

8. Arms, Groups, and Interventions

Arm Title

GILUPI CellCollector®

Arm Type

Experimental

Intervention Type

Device

Intervention Name(s)

GILUPI CellCollector®

Intervention Description

Use of GILUPI CellCollector® to detect CTC

Primary Outcome Measure Information:

Title

Predictive value of CTC in ypT0 ypN0

Time Frame

Change from pre-chemotherapy to 22-28(±7) days after first dose of neoadjuvant chemotherapy

Secondary Outcome Measure Information:

Title

Predictive value of CTC in ypT0, ypT0/is ypN0, near pCR

Time Frame

before and 22-28(±7) days after first dose of neoadjuvant chemotherapy

Title

hypersensitivity

Description

Number of participants with hypersensitivity as assessed by CTCAE v4.0

Time Frame

up to 1 year

Title

Detection rate of GILUPI CellCollector®

Time Frame

before and 22-28(±7) days after first dose of neoadjuvant chemotherapy

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients with histologically confirmed primary invasive breast adenocarcinoma, anatomic stage T2-4N0-3M0 or T1N1-3M0 before neoadjuvant chemotherapy ECOG 0-1 Adequate organ function Consent to undergo CTC analysis in vivo Exclusion Criteria: Pregnant or breastfeeding patients Metastatic or recurrent patients Uncontrollable infection

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jinsong Lu

Organizational Affiliation

RenJi Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Renji Hospital, School of Medicine, Shanghai Jiao Tong University

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200127

Country

China

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

CTC in Predicting Neoadjuvant Chemotherapy Among LABC Patients: a Single-center, Prospective, Exploratory Clinical Trial

We'll reach out to this number within 24 hrs