Clinical trial NCT00417495: Sentinel Lymph Node Technique in Multifocal Breast Cancer
Official title: Interest of Sentinel Lymph Node Technique in Women With a Multifocal Breast Cancer - IGASSU-0502
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Cancer
Keywords: adenocarcinoma, breast, multifocal lesions, surgery
Lead sponsor: Centre Oscar Lambret
Sponsor class: OTHER
First posted: 2007-01-01
Enrollment: 216
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: detection rate of sentinel nodes
timeFrame: surgery
Secondary outcomes:
measure: number of sentinel nodes removed
timeFrame: surgery
measure: localisation of the sentinel nodes
timeFrame: surgery
Other outcomes:
Locations:
city: Amiens
country: France
facility: Centre Hospitalier Universitaire
city: Angers
country: France
facility: Centre Paul Papin
city: Bordeaux
country: France
facility: Institut Bergonie
city: Clermont-Ferrand
country: France
facility: Centre Jean Perrin
city: Coudekerque Branche
country: France
facility: Clinique de Flandre
city: Dijon
country: France
facility: Centre Georges-Francois LECLERCQ
city: Lille
country: France
facility: Centre Oscar Lambret
city: Lyon
country: France
facility: Centre Leon Berard
city: Marseille
country: France
facility: Institut Paoli Calmettes
city: Montpellier
country: France
facility: CRLC Val d'Aurelle
city: Paris
country: France
facility: Hôpital Lariboisière
city: Paris
country: France
facility: Hopital Tenon
city: Rennes
country: France
facility: Centre Eugene Marquis
city: Rouen
country: France
facility: Centre Henri Becquerel
city: SAINT JULIEN en GENEVOIS
country: France
facility: Centre Hospitalier Sud Léman Valsérine
city: Saint-Herblain
country: France
facility: Centre Rene Gauducheau
city: THONON-les-BAINS
country: France
facility: Hôpital Georges PIANTA
city: Toulouse
country: France
facility: Centre Claudius Regaud
city: Valenciennes
country: France
facility: Centre Hospitalier
city: Villejuif
country: France
facility: Institut Gustave Roussy
Study officials:
affiliation: Centre Oscar Lambret
name: GIARD Sylvia, MD
role: PRINCIPAL_INVESTIGATOR
References: