Back to resultsTo Accurately Assess Lymph Node Response to NACT by Wire Localization of Clip-marked Lymph Nodes
Primary Purpose
Neoplasm, Breast, Neoadjuvant Chemotherapy, Lymph Node Metastases
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
wire localization
Sponsored by
About this trial
This is an interventional diagnostic trial for Neoplasm, Breast focused on measuring Neoplasm, Breast, neoadjuvant chemotherapy, Lymph Node Metastases, response
Eligibility Criteria
Inclusion Criteria:
- between the age of 18 and 65
- Eastern Cooperative Oncology Group (ECOG) score 0 or 1
- pathologically proven positive axillary lymph node
- enough renal and liver function to sustain chemotherapy
- informed consent obtained
Exclusion Criteria:
- inflammatory breast cancer
- being pregnant or nursing
- neoadjuvant chemotherapy not planned
Sites / Locations
- Beijing Cancer Hospital Breast CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Wire localization
Arm Description
Intervention: procedure: wire localization
Outcomes
Primary Outcome Measures
The accuracy of SLNB alone and in combination with the removal of wire-localized-clip-marked nodes.
Sensitivity, specificity, false negative rate and negative predictive value will be calculated.
Secondary Outcome Measures
Model to predict lymph node pCR in cN1 patients.
Using clinical pathological and image data collected, generate a model to predict lymph node pCR in cN1 patients.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03715686
Brief Title
To Accurately Assess Lymph Node Response to NACT by Wire Localization of Clip-marked Lymph Nodes
Official Title
To Accurately Assess Lymph Node Response to Neoadjuvant Chemotherapy by Wire Localization of Clip-marked Axillary Lymph Nodes in Breast Cancer Patients
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
October 20, 2018 (Actual)
Primary Completion Date
June 20, 2022 (Anticipated)
Study Completion Date
June 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The investigator developed this protocol to accurately assess lymph node response to neoadjuvant chemotherapy in clinical stage N1 (cN1) breast cancer patients. Accuracy of sentinel lymph node biopsy (SLNB) alone and in combination with the removal of wire-localized-clip-marked nodes will be analyzed. New model to predict lymph node pathological complete remission (pCR) so as to safely avoid axillary lymph node dissection in cN1 breast cancer patients is sought for.
Detailed Description
The investigator developed this protocol to accurately assess lymph node response to neoadjuvant chemotherapy in cN1 breast cancer patients. In brief, pathologically proven positive axillary lymph node will be clip-marked before the initiation of neoadjuvant chemotherapy (NACT) and continuously monitored through out the course of chemotherapy with ultrasound. After the completion of neoadjuvant chemotherapy, a wire will be placed to localize the clip-marked node before surgery. During surgery, a standard sentinel lymph node biopsy will be performed as well as the removal of the wire localized node. Axillary lymph node dissection (ALND) will be performed in all participants. Accuracy of SLNB alone and in combination with the removal of wire-localized-clip-marked nodes will be analyzed. Axillary ultrasound and CT scan will be performed before and after neoadjuvant chemotherapy for all patients enrolled. By assessing clinical-pathological and imaging data acquired from this trial, the investigator look forward to developing a model to accurately predict lymph node pCR (AUC >0.85) so as to safely avoid axillary lymph node dissection in cN1 breast cancer patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neoplasm, Breast, Neoadjuvant Chemotherapy, Lymph Node Metastases, Response
Keywords
Neoplasm, Breast, neoadjuvant chemotherapy, Lymph Node Metastases, response
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
230 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Wire localization
Arm Type
Experimental
Arm Description
Intervention: procedure: wire localization
Intervention Type
Procedure
Intervention Name(s)
wire localization
Intervention Description
Pathologically proven positive axillary lymph node will be clip-marked before the initiation of neoadjuvant chemotherapy. After the completion of neoadjuvant chemotherapy, a wire will be placed to localize the clip-marked node before surgery. During surgery, a standard sentinel lymph node biopsy will be performed as well as the removal of the wire localized node. ALND will be performed in all participants.
Primary Outcome Measure Information:
Title
The accuracy of SLNB alone and in combination with the removal of wire-localized-clip-marked nodes.
Description
Sensitivity, specificity, false negative rate and negative predictive value will be calculated.
Time Frame
through study completion, an average of 1 year
Secondary Outcome Measure Information:
Title
Model to predict lymph node pCR in cN1 patients.
Description
Using clinical pathological and image data collected, generate a model to predict lymph node pCR in cN1 patients.
Time Frame
through study completion, an average of 1 year
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
between the age of 18 and 65
Eastern Cooperative Oncology Group (ECOG) score 0 or 1
pathologically proven positive axillary lymph node
enough renal and liver function to sustain chemotherapy
informed consent obtained
Exclusion Criteria:
inflammatory breast cancer
being pregnant or nursing
neoadjuvant chemotherapy not planned
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xinguang Wang, Dr.
Phone
+86 88271119
Ext
4002
Email
doctorwxg79@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Zhaoqing Fan, Dr.
Phone
+86 88271119
Ext
8012
Email
zhqfan@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tao Ouyang, Dr.
Organizational Affiliation
Beijing Cancer Hosptial
Official's Role
Study Director
Facility Information:
Facility Name
Beijing Cancer Hospital Breast Center
City
Beijing
Country
China
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
To Accurately Assess Lymph Node Response to NACT by Wire Localization of Clip-marked Lymph Nodes
We'll reach out to this number within 24 hrs