To Accurately Assess Lymph Node Response to NACT by Wire Localization of Clip-marked Lymph Nodes
1 other identifier
interventional
230
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2018
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 13, 2018
CompletedStudy Start
First participant enrolled
October 20, 2018
CompletedFirst Posted
Study publicly available on registry
October 23, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 20, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2022
CompletedNovember 29, 2021
September 1, 2021
3.7 years
October 13, 2018
November 26, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Model to predict lymph node pCR in cN1 patients.
through study completion, an average of 1 year
Study Arms (1)
Wire localization
EXPERIMENTALIntervention: procedure: wire localization
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- inflammatory breast cancer
- being pregnant or nursing
- neoadjuvant chemotherapy not planned
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Beijing Cancer Hospital Breast Center
Beijing, China
Related Publications (1)
Wang X, Zheng Q, He Y, Liu Y, Huo L, Zhang N, Wang T, Xie Y, Li J, Ouyang T, Fan Z. Diagnostic accuracy of sentinel lymph node biopsy and wire localized clipped node biopsy after neoadjuvant chemotherapy in node-positive breast cancer. Surg Today. 2025 Feb;55(2):172-179. doi: 10.1007/s00595-024-02981-0. Epub 2024 Dec 27.
PMID: 39725764DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Tao Ouyang, Dr.
Beijing Cancer Hosptial
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- director of the department
Study Record Dates
First Submitted
October 13, 2018
First Posted
October 23, 2018
Study Start
October 20, 2018
Primary Completion
June 20, 2022
Study Completion
June 30, 2022
Last Updated
November 29, 2021
Record last verified: 2021-09
Data Sharing
- IPD Sharing
- Will not share