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

Phase 2
18 Years
Not Enrolling
Breast Cancer

Thank you

Trial Information

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

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

- This procedure is immediately follows by complete axillary dissection during breast

- 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.

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

Type of Study:


Study Design:

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

Outcome Measure:

detection rate of sentinel nodes

Outcome Time Frame:


Safety Issue:


Principal Investigator

GIARD Sylvia, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Centre Oscar Lambret


France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:




Start Date:

March 2006

Completion Date:

September 2008

Related Keywords:

  • Breast Cancer
  • adenocarcinoma, breast, multifocal lesions, surgery
  • Breast Neoplasms