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Surgical Resection With or Without Axillary Lymph Node Dissection in Treating Women With Node-Negative Breast Cancer and Sentinel Lymph Node Micrometastases

NCT00072293 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 931

Last updated 2018-01-23

Study results available
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Summary

RATIONALE: Surgery to remove lymph nodes in the armpit in patients with sentinel lymph node micrometastases may remove cancer cells that have spread from tumors in the breast. It is not yet known whether surgery to remove the primary tumor is more effective with or without axillary lymph node dissection.

PURPOSE: This randomized phase III trial is studying surgery and axillary lymph node dissection to see how well they work compared to surgery alone in treating women with node-negative breast cancer and sentinel lymph node micrometastases.

Conditions

Interventions

PROCEDURE

Axillary lymph node dissection

Axillary lymph node dissection

PROCEDURE

No axillary lymph node dissection

Therapeutic conventional surgery

Sponsors & Collaborators

  • ETOP IBCSG Partners Foundation

    lead NETWORK

Principal Investigators

  • Viviana E. Galimberti · European Institute of Oncology

  • Umberto Veronesi, MD, Prof. · European Institute of Oncology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-12-31
Primary Completion
2012-09-30
Completion
2017-03-31

Countries

  • Australia
  • Belgium
  • Brazil
  • Denmark
  • France
  • Italy
  • New Zealand
  • Peru
  • Slovenia
  • Switzerland

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00072293 on ClinicalTrials.gov