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

NCT ID: NCT03715686

Last Updated: 2021-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

230 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-20

Study Completion Date

2022-06-30

Brief Summary

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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

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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.

Conditions

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Neoplasm, Breast Neoadjuvant Chemotherapy Lymph Node Metastases Response

Keywords

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Neoplasm, Breast neoadjuvant chemotherapy Lymph Node Metastases response

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Wire localization

Intervention: procedure: wire localization

Group Type EXPERIMENTAL

wire localization

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Peking University

OTHER

Sponsor Role lead

Responsible Party

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Tao OUYANG

director of the department

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tao Ouyang, Dr.

Role: STUDY_DIRECTOR

Beijing Cancer Hosptial

Locations

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Beijing Cancer Hospital Breast Center

Beijing, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Xinguang Wang, Dr.

Role: CONTACT

Phone: +86 88271119

Email: [email protected]

Zhaoqing Fan, Dr.

Role: CONTACT

Phone: +86 88271119

Email: [email protected]

References

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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.

Reference Type DERIVED
PMID: 39725764 (View on PubMed)

Other Identifiers

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BCP24

Identifier Type: -

Identifier Source: org_study_id