Sentinel Lymph Node Technique in Multifocal Breast Cancer

Phase 2

Completed

• Conditions: Breast Cancer

• Registration Number: NCT00417495
• Lead Sponsor: Centre Oscar Lambret

Brief Summary

The scope of this trial is to assess the Sentinel Lymph Node Technique in Multifocal Breast Cancer

Detailed Description

The sentinel lymph node is located preferentially by:

* association of subareolar injection of technecium and blue dye

* or, in case of blue dye allergy, by the subareolar injection of technecium only

* or, in case of no possibility of radioactive isotope subareolar injection , by blue dye injection only This procedures are made the day before the surgery or the day of the surgery

* This procedure is immediately follows by complete axillary dissection during breast surgery

* The anatomopathologic analysis of the 2 samples (sentinel lymph node and axillary dissection) and the histologic confirmation on the removed tumor of the multifocal nature of the breast cancer correspond to the end of the study for the patient.

Study Timeline

• Study Start: 2006-03
• Study First Submitted: 2006-12-29
• Study First Submitted QC: 2006-12-29
• Study First Posted: 2007-01-01
• Primary Completion: 2008-09
• Study Completion: 2008-09
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-05
• Last Update Posted: 2016-01-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 216

Inclusion Criteria

• Multifocal invasive breast cancer
• At least 2 focuses (clinically and/or by mammography or ultrasound)
• Proven by pre-surgical histology (on 1 focus at least)
• Age > 18 years old
• Clinically negative axillary lymph nodes
• No treatment before surgery
• Signature of written informed consent

Exclusion Criteria

• Multifocality proven after surgery
• Non invasive breast cancer
• Inflammatory breast cancer
• Axillary lymph node
• Metastatic disease
• Previous homolateral breast cancer
• Dementia or alterated mental status
• Pregnant or lactating woman

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
detection rate of sentinel nodes	surgery

Secondary Outcome Measures

Name	Time	Method
number of sentinel nodes removed	surgery
localisation of the sentinel nodes	surgery

Trial Locations

Locations (20)

Centre Hospitalier Universitaire; 🇫🇷 Amiens, France

Centre Paul Papin; 🇫🇷 Angers, France

Centre Jean Perrin; 🇫🇷 Clermont-Ferrand, France

Hôpital Lariboisière; 🇫🇷 Paris, France

Centre Claudius Regaud; 🇫🇷 Toulouse, France

Centre Hospitalier; 🇫🇷 Valenciennes, France

Institut Bergonie; 🇫🇷 Bordeaux, France

CRLC Val d'Aurelle; 🇫🇷 Montpellier, France

Centre Hospitalier Sud Léman Valsérine; 🇫🇷 SAINT JULIEN en GENEVOIS, France

Hôpital Georges PIANTA; 🇫🇷 THONON-les-BAINS, France

Hopital Tenon; 🇫🇷 Paris, France

Clinique de Flandre; 🇫🇷 Coudekerque Branche, France

Centre Georges-Francois LECLERCQ; 🇫🇷 Dijon, France

Centre Oscar Lambret; 🇫🇷 Lille, France

Institut Paoli Calmettes; 🇫🇷 Marseille, France

Centre Leon Berard; 🇫🇷 Lyon, France

Centre Eugene Marquis; 🇫🇷 Rennes, France

Centre Henri Becquerel; 🇫🇷 Rouen, France

Centre Rene Gauducheau; 🇫🇷 Saint-Herblain, France

Institut Gustave Roussy; 🇫🇷 Villejuif, France