CTC in Predicting Neoadjuvant Chemotherapy Among LABC Patients: a Single-center, Prospective, Exploratory Clinical Trial
Not Applicable
Completed
- Conditions
- Locally Advanced Breast CancerCirculating Tumor Cell
- Interventions
- Device: GILUPI CellCollector®
- Registration Number
- NCT03732339
- Lead Sponsor
- RenJi Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 29
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description GILUPI CellCollector® GILUPI CellCollector® -
- Primary Outcome Measures
Name Time Method Predictive value of CTC in ypT0 ypN0 Change from pre-chemotherapy to 22-28(±7) days after first dose of neoadjuvant chemotherapy
- Secondary Outcome Measures
Name Time Method Detection rate of GILUPI CellCollector® before and 22-28(±7) days after first dose of neoadjuvant chemotherapy Predictive value of CTC in ypT0, ypT0/is ypN0, near pCR before and 22-28(±7) days after first dose of neoadjuvant chemotherapy hypersensitivity up to 1 year Number of participants with hypersensitivity as assessed by CTCAE v4.0
Trial Locations
- Locations (1)
Renji Hospital, School of Medicine, Shanghai Jiao Tong University
🇨🇳Shanghai, Shanghai, China