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

What this trial studies

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

Conditions in scope

• Breast Cancer

Interventions

• Conventional surgery WITHOUT Axillary Lymph Node Excision (Procedure) — Tumorectomy or mastectomy, WITHOUT Axillary Lymph Node Excision
• Conventional surgery WITH Axillary Lymph Node Excision (Procedure)

Who can join

Women only · Ages 50 Years to 100 Years

Inclusion criteria

• Women, 50 year or more Menopausal women Breast cancer Macroscopic tumor size of 10 mm or less (measured during operation) No palpable axillary node ( N0)

Exclusion criteria

• Previous cancer history life expectancy \< 10 years Metastasis

Eligibility wording paraphrased from the public record. View the full criteria on ClinicalTrials.gov before contacting a site.

Where it’s happening

Showing the first 10 of 14 sites. See all sites on ClinicalTrials.gov.

Status & timeline

• Overall status: Terminated
• Study type: Interventional
• Phase: PHASE3
• Start date: 1995-09
• Primary completion: 2005-12
• Last update posted: 2025-10-20
• First posted: 2005-09-21

Sponsor & contact

Lead sponsor: Institut Bergonié (Other)

For trial site contact information, use the official record at ClinicalTrials.gov. Contact details change frequently and the public record is the source of truth.

Outcome measures

Primary outcomes

• Number of Deaths (Five years after surgery)

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