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Completed

NCT Number: NCT03732339

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

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.

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Key information

Conditions

Locally Advanced Breast Cancer Circulating Tumor Cell Neoplasm Metastasis Neoplasms Neoplastic Cells, Circulating Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Renji Hospital, School of Medicine, Shanghai Jiao Tong University

Shanghai, Shanghai Municipality, 200127, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

GILUPI CellCollector®

Device

Use of GILUPI CellCollector® to detect CTC

Primary outcomes

  1. 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

  1. 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

  2. hypersensitivity

    Time frame: up to 1 year

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

  3. Detection rate of GILUPI CellCollector®

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

Sponsors and collaborators

Lead sponsor

RenJi Hospital

Other

Collaborators

  • Beijing Viroad Biotechnology Co., Ltd.

Registry information

Official study title

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

Acronym: CTCNeoBC

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Nov 6, 2018
Registry last updated
Apr 29, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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