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CompletedNCT00417495IGASSUUpdated Sep 17, 2026

Sentinel Lymph Node Technique in Multifocal Breast Cancer

A Phase 2 interventional study of Sentinel Lymph Node Technique in Breast Cancer, sponsored by Centre Oscar Lambret. Completed at 20 sites in France. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-17.

Sponsored by Centre Oscar Lambret · Phase 2, Interventional, and Diagnostic

From the registry’s dates

  • Registered 9 months after the study started (first participant enrolled Mar 2006, registered Dec 2006).
Phase
Phase 2
Study type
Interventional
Enrollment
216
Allocation
Non-randomized
Ages
18 Years and older
Sex
Female
01

Study summary

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

Read the 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.
02

Conditions studied

  • Breast Cancer

Keywords

  • adenocarcinoma, breast, multifocal lesions, surgery
03

In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's enrollment of 216 is above the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

Centre Oscar Lambret is the lead sponsor of 127 studies on the registry; 13 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 2
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
216 participants (actual)

Interventions

  • BehavioralSentinel Lymph Node Technique
06

What researchers measure

Primary outcomes

  1. detection rate of sentinel nodes

    Time frame: surgery

Secondary outcomes

  1. number of sentinel nodes removed

    Time frame: surgery

  2. localisation of the sentinel nodes

    Time frame: surgery

07

Study locations

20 sites
  • Centre Hospitalier Universitaire
    Amiens, 80054, France
  • Centre Paul Papin
    Angers, 49933, France
  • Institut Bergonie
    Bordeaux, 33076, France
  • Centre Jean Perrin
    Clermont-Ferrand, 63011, France
  • Clinique de Flandre
    Coudekerque-Branche, 59210, France
  • Centre Georges-Francois LECLERCQ
    Dijon, 21000, France
  • Centre Oscar Lambret
    Lille, 59020, France
  • Centre Leon Berard
    Lyon, 69373, France
  • Institut Paoli Calmettes
    Marseille, 130009, France
  • CRLC Val d'Aurelle
    Montpellier, 34298, France
  • Hôpital Lariboisière
    Paris, 75010, France
  • Hopital Tenon
    Paris, 75970, France
  • Centre Eugene Marquis
    Rennes, 35042, France
  • Centre Henri Becquerel
    Rouen, 76038, France
  • Centre Rene Gauducheau
    Saint-Herblain, 44805, France
  • Centre Hospitalier Sud Léman Valsérine
    Saint-Julien-en-Genevois, 74167, France
  • Hôpital Georges PIANTA
    Thonon-les-Bains, 74203, France
  • Centre Claudius Regaud
    Toulouse, 31052, France
  • Centre Hospitalier
    Valenciennes, 59300, France
  • Institut Gustave Roussy
    Villejuif, 94808, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 17, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00417495
Lead sponsor
Centre Oscar Lambret
Responsible party
Sponsor
First posted
Jan 1, 2007
Start date
Mar 2006
Primary completion
Aug 13, 2010
Completion
Aug 13, 2010
Last update
Sep 17, 2026

Study contacts

GIARD Sylvia, MD
principal investigator · Centre Oscar Lambret
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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