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

Sponsor
Gangnam Severance Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT06149884
Collaborator
(none)
978
Enrollment
137.9
Actual Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Sentinel lymph node biopsy, axillary lymph node dissection

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 Design

Study Type:
Observational
Actual Enrollment :
978 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Micrometastases in Axillary Lymph Nodes in Breast Cancer, Post-neoadjuvant Chemotherapy
Actual Study Start Date :
Sep 1, 2006
Actual Primary Completion Date :
Feb 28, 2018
Actual Study Completion Date :
Feb 28, 2018

Outcome Measures

Primary Outcome Measures

  1. Recurrence-free survival [the interval from breast cancer diagnosis to the initial recurrence or death upto 5 years]

    locoregional recurrence, distant metastasis, any cause of death

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Gangnam Severance Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Joon Jeong, Proffesor, Gangnam Severance Hospital
ClinicalTrials.gov Identifier:
NCT06149884
Other Study ID Numbers:
  • 3-2023-0214
First Posted:
Nov 29, 2023
Last Update Posted:
Nov 29, 2023
Last Verified:
Nov 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Neoplasm Micrometastasis

Study Results

No Results Posted as of Nov 29, 2023