Sentinel Lymph Node Technique in Multifocal Breast Cancer

Centre Oscar Lambret

Status and phase: Completed; Phase 2

Conditions: Breast Cancer

Treatments: Behavioral: Sentinel Lymph Node Technique

Study type: Interventional

Funder types: Other

Identifiers

NCT00417495

IGASSU 0502

Details and patient eligibility

About

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

Full 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.

Enrollment: 216 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)