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Recruiting NCT05360290

CTCs in Breast Cancer After Neoadjuvant Treatment and Surgery: a Multicenter, Prospective Clinical Trial

No phase Interventional Breast Cancer Circulating Tumor Cell

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: GILUPI CellCollector®.
Who it may be relevant to
Registry conditions: Breast Cancer, Circulating Tumor Cell. Basic parameters: 18 years — 70 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

The Value of Circulating Tumor Cells in Patients With Breast Cancer Who Completed Surgery After Neoadjuvant Treatment: a Multicenter, Prospective Clinical Trial

Overview

The GILUPI CellCollector® is the first in vivo CTC isolation product worldwide, which is CE approved. This is a prospective, multicenter study to evaluate the prognostic value of circulating tumor cells in breast cancer patients who completed surgery after neoadjuvant treatment.

Interventions

  • Device GILUPI CellCollector®
    Use of GILUPI CellCollector® to detect CTC

Primary outcome measures

  • invasive disease-free survival (iDFS) [Time frame: From surgery until time of event up to 3 years]
Secondary outcome measures (2)
  • pathological complete response (pCR) [Time frame: at surgery]
  • overall Survival (OS) [Time frame: From surgery until time of event up to 3 years]

Eligibility criteria

Inclusion criteria

  • Female, aged ≥18 and ≤70 years;
  • Histologically confirmed invasive breast cancer (cT2-4N0-2M0 or cT1N1-3M0 before neoadjuvant treatment);
  • Completed neoadjuvant treamtment and surgery (within 4 years after surgery);
  • Administered neoadjuvant chemotherapy (regardless of chemotherapy regimen);
  • ECOG 0-1

Exclusion criteria

  • Metastatic disease (Stage IV);
  • Female patients who are pregnancy or lactation;
  • Uncontrollable puncture site infection or systemic infection;

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Screening

Study locations

China · 1 center
  • Renji Hospital, School of Medicine, Shanghai Jiao Tong University — Shanghai

Identifiers

NCT: NCT05360290 · KY2022-044-B

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗