CTCs in Breast Cancer After Neoadjuvant Treatment and Surgery: a Multicenter, Prospective Clinical Trial (CTCNeoBC-E)

Shanghai Jiao Tong University

Status: Enrolling

Conditions: Breast Cancer; Circulating Tumor Cell

Treatments: Device: GILUPI CellCollector®

Study type: Interventional

Funder types: Other

Identifiers

NCT05360290

KY2022-044-B

Details and patient eligibility

About

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.

Enrollment: 484 estimated patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Screening

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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484 participants in 2 patient groups

CTC positive

Active Comparator group

Treatment:

Device: GILUPI CellCollector®

CTC negative

Other group

Treatment:

Device: GILUPI CellCollector®