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

NCT03715686 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 230

Last updated 2021-11-29

No results posted yet for this study

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.

Conditions

  • Neoplasm, Breast
  • Neoadjuvant Chemotherapy
  • Lymph Node Metastases
  • Response

Interventions

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.

Sponsors & Collaborators

  • Peking University

    lead OTHER

Principal Investigators

  • Tao Ouyang, Dr. · Beijing Cancer Hosptial

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-20
Primary Completion
2022-06-20
Completion
2022-06-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03715686 on ClinicalTrials.gov