Health TrialsbyHealthPanel

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

ConditionsBreast CancerCirculating Tumor Cell
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-70
SponsorRenJi Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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);

Disqualifiers

Metastatic disease (Stage IV);

Female patients who are pregnancy or lactation;

Uncontrollable puncture site infection or systemic infection;

Trial design

Design model

Parallel

Treatments tested in this trial

  • GILUPI CellCollector®

    Device

    Use of GILUPI CellCollector® to detect CTC

Treatment groups

484 Participants
are divided into 2 treatment groups
Group A: CTC positiveActive comparator 1 intervention
Group B: CTC negativeOther 1 intervention

Trial outcomes

Primary outcomes

1

invasive disease-free survival (iDFS)

Invasive disease-free survival time is defined as the time from date of randomization until the first occurrence of invasive disease recurrence, distant metastasis and death from any cause.

Time frame
From surgery until time of event up to 3 years

Secondary outcomes

1

pathological complete response (pCR)

ypT0 ypN0, ypT0/is ypN0, ypT0 or ypT0/is

Time frame
at surgery
2

overall Survival (OS)

Overall survival is defined as the time from randomization to death from any cause.

Time frame
From surgery until time of event up to 3 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

RenJi Hospital

Lead sponsor

Source ClinicalTrials.gov
Apply now