NCT00210236

Surgical Breast Resection With or Without Axillary Lymph Node Excision in Treating Women With Breast Cancer

Surgical Resection With or Without Axillary Lymph Node Excision in Treating Menopausal Women With Infiltrative Breast Cancer Smaller Than 10 mm

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 625 (actual)
• Sponsor: Institut Bergonié · Academic / Other
• Sex: Female
• Age: 50 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

This randomized phase III trial is studying surgery and axillary lymph node dissection to evaluate if systematic Axillary Lymph Node Excision can be avoided in locoregional treatment for operable breast cancer smaller than 10 mm among menopausal women older than 50

Detailed description

Phase III randomized multicenter equivalence trial evaluating the role of Axillary Lymph Node Excision. Primary aim is to assess if it is possible to avoid routine Axillary Lymph Node Excision during the initial treatment of breast cancers smaller than 11 mm in women aged 50 and older without compromising survival? The primary endpoint is overall survival: the event considered will be death from any cause.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
PROCEDURE	Conventional surgery WITHOUT Axillary Lymph Node Excision	Tumorectomy or mastectomy, WITHOUT Axillary Lymph Node Excision
PROCEDURE	Conventional surgery WITH Axillary Lymph Node Excision

Timeline

• Start date: 1995-09-01
• Primary completion: 2005-12-01
• Completion: 2005-12-01
• First posted: 2005-09-21
• Last updated: 2025-10-20
• Results posted: 2025-10-20

Locations

14 sites across 1 country: France