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

Institut Bergonié14 sites in 1 country625 target enrollmentSeptember 1, 1995

ConditionsBreast Cancer

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Breast Cancer
Sponsor: Institut Bergonié
Enrollment: 625
Locations: 14
Primary Endpoint: Number of Deaths
Status: Terminated
Last Updated: 6 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

September 1, 1995

End Date

December 1, 2005

Last Updated

6 months ago

Study Type

Interventional

Study Design

Parallel