The Association Between Axillary Lymph Node Metastasis Patterns and Breast Cancer Prognosis

The Association Between Axillary Lymph Node Metastasis Patterns and Breast Cancer Prognosis：a Real-world Study

This is a real-world multicentre study to investigate the metastatic pattern of axillary lymph node and its association with breast cancer prognosis.

Study Overview

• Status: Active, not recruiting
• Conditions: Breast Cancer Invasive
• Intervention / Treatment: Procedure: ALND

• Study Type: Observational
• Enrollment (Estimated): 2467

Contacts and Locations

Study Locations

• China
  • Shanghai, China, 200127
    • Renji Hospital, School of Medicine, Shanghai Jiaotong University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients were pathologically diagnosed primary invasive breast cancer from October 2013 to December 2023. They had axillary lymph node dissection.

Description

Inclusion Criteria:

• Aged 18 years or older
• Pathologically confirmed invasive primary breast cancer

Exclusion Criteria:

• De novo stage IV breast cancer

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
ALND; breast cancer patients receiving axillary lymph mode dissection	Procedure: ALND; axillary lymph node dissection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease free survival	Disease-free survival time is defined as the time from the date of axillary lymph node dissection until the date of the first occurrence of local/regional relapse, distant recurrence, contralateral breast cancer, second malignancy and death from any cause.	From the date of axillary lymph node dissection until time of event up to 3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recurrence-free survival	Recurrence-free survival time is defined as the time from the date of axillary lymph node dissection until the date of the first occurrence of local/regional recurrence, distant recurrence and death from any cause	From the date of axillary lymph node dissection until time of event up to 3 years
Overall survival	Overall survival time is defined as the time from the date of axillary lymph node dissection until death from any cause	From the date of axillary lymph node dissection until time of event up to 3 years

Collaborators and Investigators

• Sponsor: Wenjin Yin
• Investigators: Principal Investigator: Wenjin Yin, M.D., Renji Hospital, School of Medicine, Shanghai Jiao Tong University

Study record dates

Study Major Dates

• Study Start (Actual): September 28, 2025
• Primary Completion (Actual): October 11, 2025
• Study Completion (Estimated): September 28, 2026

Study Registration Dates

• First Submitted: December 4, 2025
• First Submitted That Met QC Criteria: December 4, 2025
• First Posted (Actual): December 16, 2025

Study Record Updates

• Last Update Posted (Actual): May 13, 2026
• Last Update Submitted That Met QC Criteria: May 10, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: LY2025-298-B

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No