Micrometastases in Axillary Lymph Nodes in Breast Cancer, Post-neoadjuvant Chemotherapy

November 20, 2023 updated by: Joon Jeong, Gangnam Severance Hospital
This study aims to investigate the significance of minimal residual axillary disease following NAC, with a particular focus on micrometastases (ypNmi), in comparison to pathologic lymph node-negative (ypN0) or macrometastases (ypN+). The investigators will further explore the prognostic implications of SLNmi for the prediction of axillary LN status and survival outcomes.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study aims to investigate the significance of minimal residual axillary disease following NAC, with a particular focus on micrometastases (ypNmi), in comparison to pathologic lymph node-negative (ypN0) or macrometastases (ypN+). The investigators will further explore the prognostic implications of SLNmi for the prediction of axillary LN status and survival outcomes.

Study Type

Observational

Enrollment (Actual)

978

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

We conducted a retrospective review of primary breast cancer patients from the breast cancer registries of Gangnam Severance Hospital and Severance Hospital, who underwent surgery following NAC between September 2006 and February 2018. These patients were clinically diagnosed with stage II or III breast cancer and underwent ALND, with or without SLNB. The surgical approach, encompassing either total mastectomy or breast-conserving surgery, was dictated by the number and size of the tumors present. Exclusion criteria comprised of patients who had initial surgery, underwent only SLNB, or presented with de novo stage IV disease.

Description

Inclusion Criteria:

  • Stage II or III primary breast cancer patients
  • Patients who performed neoadjuvant chemotherpay
  • Patients who underwent axillary lymph node dissection with or without sentinel lymph node biopsy

Exclusion Criteria:

  • Patients who performed upfront surgery
  • De novo stage IV patients

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recurrence-free survival
Time Frame: the interval from breast cancer diagnosis to the initial recurrence or death upto 5 years
locoregional recurrence, distant metastasis, any cause of death
the interval from breast cancer diagnosis to the initial recurrence or death upto 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gangnam Severance Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2006

Primary Completion (Actual)

February 28, 2018

Study Completion (Actual)

February 28, 2018

Study Registration Dates

First Submitted

November 14, 2023

First Submitted That Met QC Criteria

November 20, 2023

First Posted (Actual)

November 29, 2023

Study Record Updates

Last Update Posted (Actual)

November 29, 2023

Last Update Submitted That Met QC Criteria

November 20, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3-2023-0214

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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