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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03732339
Acronym
CTCNeoBC
Enrollment
29
Registered
2018-11-06
Start date
2018-08-24
Completion date
2019-06-30
Last updated
2022-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Circulating Tumor Cell, Locally Advanced Breast Cancer

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.

Interventions

DEVICEGILUPI CellCollector®

Use of GILUPI CellCollector® to detect CTC

Sponsors

Beijing Viroad Biotechnology Co., Ltd.
CollaboratorINDUSTRY
RenJi Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Predictive value of CTC in ypT0 ypN0Change from pre-chemotherapy to 22-28(±7) days after first dose of neoadjuvant chemotherapy

Secondary

MeasureTime frameDescription
Predictive value of CTC in ypT0, ypT0/is ypN0, near pCRbefore and 22-28(±7) days after first dose of neoadjuvant chemotherapy—
hypersensitivityup to 1 yearNumber of participants with hypersensitivity as assessed by CTCAE v4.0
Detection rate of GILUPI CellCollector®before and 22-28(±7) days after first dose of neoadjuvant chemotherapy—

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026