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

RenJi Hospital29 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Locally Advanced Breast Cancer Circulating Tumor Cell

Interventions

GILUPI CellCollector®DEVICE

Use of GILUPI CellCollector® to detect CTC

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (1)

Renji Hospital, School of Medicine, Shanghai Jiao Tong University

Shanghai, Shanghai Municipality, China

Outcomes

Primary Outcomes

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 Outcomes

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

hypersensitivity

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

Time frame: up to 1 year

Detection rate of GILUPI CellCollector®

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

Data from ClinicalTrials.gov

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