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

Shanghai Jiao Tong University

Status: Completed

Conditions: Locally Advanced Breast Cancer; Circulating Tumor Cell

Treatments: Device: GILUPI CellCollector®

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03732339

RenJiH-2018-038

Details and patient eligibility

About

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.

Enrollment: 29 patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

29 participants in 1 patient group

GILUPI CellCollector®

Experimental group

Treatment:

Device: GILUPI CellCollector®