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NCT Number: NCT05360290

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

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Circulating Tumor Cell Neoplasm Metastasis Neoplasms Neoplasms by Site Neoplastic Cells, Circulating Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases

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

Location status: Recruiting

Location contact

Jinsong Lu, MD

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

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

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;

Treatment and study plan

GILUPI CellCollector®

Device

Use of GILUPI CellCollector® to detect CTC

Primary outcomes

  1. invasive disease-free survival (iDFS)

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

    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.

Secondary outcomes

  1. pathological complete response (pCR)

    Time frame: at surgery

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

  2. overall Survival (OS)

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

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

Study contacts

Contact information is provided by the study sponsor or research team.

Qi Lu

CONTACT

[email protected]

86(21)68383364

Wenji Yin

CONTACT

[email protected]

86(21)68385569

Sponsors and collaborators

Lead sponsor

RenJi Hospital

Other

Registry information

Official study title

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

Acronym: CTCNeoBC-E

Important dates

Study start
2022
Primary completion
2026
Study completion
2029
First posted
May 4, 2022
Registry last updated
Feb 3, 2026

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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