Axillary Sentinel Lymph Node Detection in Breast Cancers > 2 cm (GAS2PLUS)

September 25, 2012 updated by: Centre Leon Berard

Evaluation of the Technique of Axillary Sentinel Lymph Node (SLN) Detection in Breast Cancers > 2 cm

The purpose of this study is to evaluate the quality criteria of the SLN detection technique in breast cancer patients with a tumor size (clinical measurement) greater than 2 centimeters (rate of false negatives, rate of detection).

Eligible patients will only be registered (no randomization). The estimated inclusion period is approximately 24 months. The duration of the research is 25 months (24 months for patient inclusion + 1 month for reception of results). The maximum participation duration of each patient is 1 month.

The number of patients required in this multicentric and prospective study is 240 (16 participating centers).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Axillary node extension is one of the major prognostic factors in breast cancer. Axillary dissection of Berg level I and II nodes is the validated method to obtain information on lymph node invasion, but it is associated with important morbidity.

Sentinel lymph node assessment (SLN) was developed to select patients likely not to have axillary node extension using a technique less invasive than conventional dissection. Axillary dissection is restricted to patients with undetected or metastatic SLN.

SLN detection involves subareolar or peri-tumoral injection of lymphotropic contrast agents which map the regional lymphatic drainage pattern of the tumor.

This technique allows an optimization of histopathological analysis: the pathologist must analyze only two nodes on average (instead of 10-15), allowing the examination of numerous tissue sections and the development of specific techniques such as immunohistochemistry.

The principal indicators of success for the technique are the detection rate, the false negative rate and the number of SLN sampled.

The assessment of feasibility is based on concomitant histopathological analysis of the SLN and of complementary lymph nodes.

There is no consensus in the literature on the SLN technique to be used for tumors with clinical size superior to 2 cm in diameter.

The aim of this prospective, multicentric study is to evaluate the performance of the SLN technique, in terms of detection rate and false negative rate, for patients with tumors greater than 2 cm (clinical measurement).

A homogeneous technique with "combined", colorimetric and isotopic SLN detection with subareolar or peri-tumoral injection will be used. This consensus "combined" technique has been validated by all investigators. The histopathological procedure will also be homogeneous, and validated within the group of pathologists of the Fédération Nationale des Centres de Lutte Contre le Cancer (FNCLCC). Breast surgery will either be a mastectomy or conservative treatment.

The primary objective of the study is to evaluate the quality criteria of the SLN detection technique in breast cancer patients with a tumor size (clinical measurement) greater than 2 centimeters (rate of false negatives, rate of detection).

The secondary objectives are:

  • Evaluation of the number of SLN sampled per patient,
  • Lymphoscintigraphic evaluation of the pattern of lymphatic drainage in breast tumors > 2 centimeters,
  • Precise histopathological description of the SLN sampled and of axillary nodes of levels I and II.

Evaluation criteria:

The primary criterion is the rate of false negatives, determined by the ratio of the number of patients with detected but negative SLN to the total number of positive non-sentinel nodes at the time of axillary dissection of levels I and II (patients classified as N+ according to the TNM system).

This rate will be determined after calculation of the detection rate, determined by the ratio of the number of patients evaluated on the total number of patients.

In agreement with international recommendations, the expected rate of false negatives should be < 5 % with a detection rate > 85 %.

Secondary criteria include:

  • Total number of sampled SLN per patient,
  • Lymphoscintigraphy: detection of SLN by means of extra-axillary markings,

  • Histopathological results:

    • SLN: metastases, capsular breach, micro metastases, isolated cells,
    • Dissection: number of positive nodes.

Study Type

Interventional

Enrollment (Actual)

249

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Angers, France, 49033
        • Centre Paul Papin
      • Bordeaux, France, 33076
        • Institut Bergonie
      • Boulogne Sur Mer, France, 62321
        • CH Boulogne sur Mer
      • Calais, France, 62107
        • CH Calais
      • Coquelles, France, 62231
        • Clinique Des 2 Caps
      • Cucq, France, 62780
        • Clinique des Acacias
      • Guilherand Granges, France, 07500
        • Clinique Pasteur
      • Lille, France, 59000
        • Centre Oscar Lambret
      • Lyon, France, 69008
        • Centre Leon Berard
      • Lyon, France, 69002
        • Hotel Dieu
      • Marseille, France, 13009
        • Institut Paoli Calmettes
      • Montpellier, France, 34005
        • Centre Val d'Aurelle
      • Pierre Benite, France, 69495
        • Centre Hospitalier Lyon Sud
      • Rang Du Fliers, France, 62180
        • CH Arrondissement Montreuil sur Mer
      • Rennes, France, 35042
        • Centre Eugene Marquis
      • Rouen, France, 76038
        • Centre Henri Becquerel
      • Saint Cloud, France, 92210
        • Centre René Huguenin
      • Saint Etienne, France, 42055
        • CHRU Saint Etienne
      • Saint Herblain, France, 44805
        • Centre Rene Gauducheau
      • Saint Martin Boulogne, France, 62280
        • CMCO
      • Toulouse, France, 31052
        • Institut Claudius Regaud
      • Vandoeuvre Les Nancy, France, 54511
        • Centre Alexis Vautrin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Female, age ≥ 18 years
  • Patient with invasive unifocal breast cancer with tumor size > 2 cm at initial examination (clinical examination and/or imaging)
  • Preoperative histological diagnosis of infiltrating mammary carcinoma
  • No lymph node at clinical examination
  • No treatment for this cancer before surgery
  • Mandatory affiliation with a social security system
  • Written, signed informed consent

Exclusion Criteria:

  • No invasive breast cancer
  • Breast tumor =< 2 cm
  • Preoperative histological diagnosis other than infiltrating mammary carcinoma
  • Multifocal breast cancer
  • Inflammatory breast cancer
  • Metastatic cancer
  • History of homolateral breast surgery
  • History of allergic disorders
  • History of homolateral breast cancer
  • Difficult follow-up
  • Pregnant or lactating woman
  • Previous inclusion in the trial

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: No label
Injection of Nanocis® or Nanocoll® (Tc-colloid) on the day before surgery followed by lymphoscintigraphy (long protocol, method n°1) or injection of Nanocis® or Nanocoll® on the morning of the surgery followed by lymphoscintigraphy at least 2h30 later (short protocol, method n° 2)
Other: No name
Injection of Nanocis® or Nanocoll® on the day before surgery followed by lymphoscintigraphy (long protocol, method n°1) or injection of Nanocis® or Nanocoll® on the morning of the surgery followed by lymphoscintigraphy at least 2h30 later (short protocol, method n° 2)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Quality criteria of the SLN detection technique
Time Frame: 1 month
1 month

Secondary Outcome Measures

Outcome Measure
Time Frame
Total number of sampled SLN per patient
Time Frame: 1 month
1 month
Detection of SLN by means of extra-axillary markings (lymphoscintigraphy)
Time Frame: 1 month
1 month
Histopathological results (SLN)
Time Frame: 1 month
1 month
Histopathological results (dissection)
Time Frame: 1 month
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Leon Berard

Collaborators

PHRC 2007: financial support

Investigators

  • Principal Investigator: Hervé MIGNOTTE, MD, Centre Léon Bérard, Lyon

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2008

Primary Completion (Actual)

September 1, 2011

Study Completion (Actual)

September 1, 2011

Study Registration Dates

First Submitted

February 8, 2008

First Submitted That Met QC Criteria

March 11, 2008

First Posted (Estimate)

March 14, 2008

Study Record Updates

Last Update Posted (Estimate)

September 26, 2012

Last Update Submitted That Met QC Criteria

September 25, 2012

Last Verified

September 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GAS2PLUS
  • ET2007-045

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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