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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03715686
Other study ID # BCP24
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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