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NCT03732339 Clinical Trial

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

Locally Advanced Breast Cancer Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03732339
Other study ID # RenJiH-2018-038
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 24, 2018
Est. completion date June 30, 2019

Study information
Verified date April 2022
Source RenJi Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 29
Est. completion date June 30, 2019
Est. primary completion date March 11, 2019
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 70 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

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 (2)
Lead Sponsor Collaborator
RenJi Hospital Beijing Viroad Biotechnology Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Predictive value of CTC in ypT0 ypN0 Change from pre-chemotherapy to 22-28(±7) days after first dose of neoadjuvant chemotherapy
Secondary Predictive value of CTC in ypT0, ypT0/is ypN0, near pCR before and 22-28(±7) days after first dose of neoadjuvant chemotherapy
Secondary hypersensitivity Number of participants with hypersensitivity as assessed by CTCAE v4.0 up to 1 year
Secondary Detection rate of GILUPI CellCollector® before and 22-28(±7) days after first dose of neoadjuvant chemotherapy
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