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

NCT07283718 | Active Not Recruiting DMC

• 1 other identifier: LY2025-298-B
• Study Type: observational
• Target: 2,467
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Breast Cancer Invasive

Outcome Measures

Primary Outcomes (1)

• 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 ALND until time of event up to 3 years

Secondary Outcomes (2)

• Recurrence-free survival

  From the date of ALND until time of event up to 3 years

• Overall survival

  From the date of ALND until time of event up to 3 years

Study Arms (1)

ALND

breast cancer patients receiving axillary lymph mode dissection

Procedure: ALND

Interventions

ALND PROCEDURE

axillary lymph node dissection

ALND

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• De novo stage IV breast cancer

Sponsors & Collaborators

• Wenjin Yin: lead

Study Sites (1)

Renji Hospital, School of Medicine, Shanghai Jiaotong University

Shanghai, 200127, China

Location

Study Officials

• Wenjin Yin, M.D.

  Renji Hospital, School of Medicine, Shanghai Jiao Tong University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Deputy Chief of Breast Surgery Department

Study Record Dates

• First Submitted: December 4, 2025
• First Posted: December 16, 2025
• Study Start: September 28, 2025
• Primary Completion: October 11, 2025
• Study Completion (Estimated): September 28, 2026
• Last Updated: December 16, 2025

Record last verified: 2025-12

Locations

CN (1)