NCT04998682

Brief Summary

The purpose of this research is to evaluate how to manage the axillary lymph nodes in patients with breast cancer. The investigators will determine if a sampling of the lymph nodes under the arm will give the information necessary to determine if fewer lymph nodes can be removed.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable breast-cancer

Timeline
Completed

Started Mar 2022

Typical duration for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 7, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 10, 2021

Completed
7 months until next milestone

Study Start

First participant enrolled

March 1, 2022

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 11, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 11, 2026

Completed
Last Updated

March 25, 2026

Status Verified

February 1, 2026

Enrollment Period

4 years

First QC Date

August 7, 2021

Last Update Submit

March 22, 2026

Conditions

Breast Cancer

Keywords

Targeted Axillary DissectionAdvanced Nodal DiseaseAxillary Lymph Node

Outcome Measures

Primary Outcomes (1)

  • False Negative Rate

    The false negative rate of targeted axillary dissection after neoadjuvant systemic therapy (NST) in study participants. A false negative event will be defined as a case where the specific node (either the clipped node or the sentinel lymph node, depending on the analysis) does not show metastasis even though residual disease is identified in the other axillary nodes. The false negative rate will be computed as the number of false negative events divided by the total number of pathologically node-positive patients.

    Up to 2 weeks

Secondary Outcomes (5)

  • Sentinel Lymph Node Identification Rate

    Day 1 (Day of Surgery)

  • Clipped Lymph Node Identification Rate

    Day 1 (Day of Surgery)

  • Accuracy Rate of Imaging Studies

    Up to 2 weeks

  • Pathologic Complete Response (pCR)

    Up to 2 weeks

  • Incidence of Treatment-Emergent Adverse Events

    Up to 3 weeks

Study Arms (1)

Targeted Axillary Dissection (TAD)

EXPERIMENTAL

During standard of care (SoC) surgery to remove breast cancer, study participants will undergo a sampling of lymph nodes in the axilla first and then complete removal of axillary lymph nodes under the arm.

Procedure: Axillary Dissection

Interventions

Axillary DissectionPROCEDURE

A surgical procedure that opens the armpit (axilla) to identify, examine, or remove lymph nodes. Axillary dissection will be performed during SoC breast cancer surgery.

Targeted Axillary Dissection (TAD)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Women or men greater than or equal to 18 years.
  • Histologically confirmed invasive adenocarcinoma of the breast.
  • Clinical T0-4 N2-3 M0 at diagnosis (American Joint Committee on Cancer, 7th Edition)
  • Assessment for cN2 disease will be performed by clinical exam and imaging. Patients should have pathologic level 1 and/or 2 axillary lymph nodes which are fixed/matted on physical exam.
  • Cross-sectional imaging will be used to identify advanced nodal disease involving the axilla, infraclavicular, supraclavicular, and internal mammary regions, cN3 disease.
  • Patients must have biopsy proven involvement of the axillary lymph nodes.
  • Receipt of standard multiagent chemotherapy +/- targeted therapy based on tumor subtype.
  • Candidate for surgical management of breast cancer.
  • Ability to understand and willingness to sign a written informed consent document.

You may not qualify if:

  • History of allergic reactions or hypersensitivity to radioactive lymph node mapping agents or blue dye.
  • Pregnancy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Miami

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Susan Kesmodel, MD

    University of Miami

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Clinical

Study Record Dates

First Submitted

August 7, 2021

First Posted

August 10, 2021

Study Start

March 1, 2022

Primary Completion

February 11, 2026

Study Completion

February 11, 2026

Last Updated

March 25, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)