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Sentinel Lymph Node Detection After Neoadjuvant Chemotherapy for Large Operable Breast Cancer

NCT01221688 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 958

Last updated 2022-04-25

No results posted yet for this study

Summary

Neoadjuvant chemotherapy (NAC) is frequently proposed to patients with large tumours that can be operated in order to increase the chances of breast conservation. After NAC, patients are operated with systematic axillary lymph node dissection (ALND), although more than half of these patients do not have lymph node involvement. These results lead us to consider the indication of the sentinel lymph node (SLN) technique after NAC in order to avoid unnecessary ALND in patients whose SLN is free of involvement.

We need to validate the SLN technique after NAC in patients who have proven lymph node involvement prior to NAC.

GANEA2 is a new trial based on patient treated for a large breast tumor with proven axillary involved nodes. Patients enrolled in this trial will have first an axillary sonography with fine needle punction in case of suspected nodes before NAC. This primary evaluation allow to determine two groups of patients : group 1 (pN+) : patients with proven involved axillary nodes and group 2, patients without proven axillary involved nodes (cN0). Patients of group 1, will undergo SLNB and complete level I-II axillary lymphadenectomy. Patients of group 2 will undergo SLNB and a complete axillary level I-II lymphadenectomy only in the case of detection failure or involved SLN and a SLNB alone in the others cases. Patients of this last group will be followed 5 years in order to evaluate the risk of axillary relapse without lymphadenectomy.

Conditions

Interventions

PROCEDURE

Axillar Sentinel lymph node biopsy

Group 2 : Patients without proven axillary involved nodes will undergo SLNB and a complete axillary level I-II lymphadenectomy only in the case of detection failure or involved SLN and a SLNB alone in the others cases. Patients of this last group will be followed 5 years in order to evaluate the risk of axillary relapse without lymphadenectomy.

PROCEDURE

SLNB and complete level I-II axillary lymphadenectomy

group 1 : patients with proven involved axillary nodes will undergo SLNB and complete level I-II axillary lymphadenectomy.

Sponsors & Collaborators

  • Institut Cancerologie de l'Ouest

    lead OTHER

Principal Investigators

  • Jean-Marc CLASSE, MD · INSTITUT DE CANCEROLOGIE DE L'OUEST

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-07-12
Primary Completion
2014-10-27
Completion
2019-12-10

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01221688 on ClinicalTrials.gov