Sentinel Lymph Node Technique in Multifocal Breast Cancer

Breast Cancer Clinical Trial

Official title:

Interest of Sentinel Lymph Node Technique in Women With a Multifocal Breast Cancer - IGASSU-0502

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00417495
• Other study ID #: IGASSU 0502
• Status: Completed
• Phase: Phase 2
• First received: December 29, 2006
• Last updated: January 5, 2016
• Start date: March 2006
• Est. completion date: September 2008

Study information

• Verified date: January 2016
• Source: Centre Oscar Lambret
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 216
• Est. completion date: September 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Behavioral:
• Sentinel Lymph Node Technique

Locations

Country	Name	City	State
France	Centre Hospitalier Universitaire	Amiens
France	Centre Paul Papin	Angers
France	Institut Bergonie	Bordeaux
France	Centre Jean Perrin	Clermont-Ferrand
France	Clinique de Flandre	Coudekerque Branche
France	Centre Georges-Francois LECLERCQ	Dijon
France	Centre Oscar Lambret	Lille
France	Centre Leon Berard	Lyon
France	Institut Paoli Calmettes	Marseille
France	CRLC Val d'Aurelle	Montpellier
France	Hôpital Lariboisière	Paris
France	Hopital Tenon	Paris
France	Centre Eugene Marquis	Rennes
France	Centre Henri Becquerel	Rouen
France	Centre Hospitalier Sud Léman Valsérine	SAINT JULIEN en GENEVOIS
France	Centre Rene Gauducheau	Saint-Herblain
France	Hôpital Georges PIANTA	THONON-les-BAINS
France	Centre Claudius Regaud	Toulouse
France	Centre Hospitalier	Valenciennes
France	Institut Gustave Roussy	Villejuif

Sponsors (1)

Lead Sponsor	Collaborator
Centre Oscar Lambret

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	detection rate of sentinel nodes		surgery	No
Secondary	number of sentinel nodes removed		surgery	No
Secondary	localisation of the sentinel nodes		surgery	No