To Accurately Assess Lymph Node Response to NACT by Wire Localization of Clip-marked Lymph Nodes

Lymph Node Metastases Clinical Trial

Official title:

To Accurately Assess Lymph Node Response to Neoadjuvant Chemotherapy by Wire Localization of Clip-marked Axillary Lymph Nodes in Breast Cancer Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03715686
• Other study ID #: BCP24
• Status: Recruiting
• Phase: N/A
• Start date: October 20, 2018
• Est. completion date: June 30, 2022

Study information

• Verified date: September 2021
• Source: Peking University
• Contact: Xinguang Wang, Dr.
• Phone: +86 88271119
• Email: doctorwxg79[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 230
• Est. completion date: June 30, 2022
• Est. primary completion date: June 20, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms
• Lymph Node Metastases
• Lymphatic Metastasis
• Neoadjuvant Chemotherapy
• Neoplasm Metastasis
• Neoplasm, Breast
• Response

Intervention

Procedure:
• wire localization
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.

Locations

Country	Name	City	State
China	Beijing Cancer Hospital Breast Center	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	through study completion, an average of 1 year
Secondary	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.	through study completion, an average of 1 year