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

This study has been completed.
Sponsor:
Collaborator:
PHRC 2007: financial support
Information provided by (Responsible Party):
Centre Leon Berard
ClinicalTrials.gov Identifier:
NCT00636467
First received: February 8, 2008
Last updated: September 25, 2012
Last verified: September 2012
  Purpose

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).


Condition Intervention Phase
Breast Cancer
Other: No name
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Evaluation of the Technique of Axillary Sentinel Lymph Node (SLN) Detection in Breast Cancers > 2 cm

Resource links provided by NLM:


Further study details as provided by Centre Leon Berard:

Primary Outcome Measures:
  • Quality criteria of the SLN detection technique [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Total number of sampled SLN per patient [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • Detection of SLN by means of extra-axillary markings (lymphoscintigraphy) [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • Histopathological results (SLN) [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • Histopathological results (dissection) [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Enrollment: 249
Study Start Date: March 2008
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00636467

Locations
France
Centre Paul Papin
Angers, France, 49033
Institut Bergonié
Bordeaux, France, 33076
CH Boulogne sur Mer
Boulogne Sur Mer, France, 62321
CH Calais
Calais, France, 62107
Clinique des 2 Caps
Coquelles, France, 62231
Clinique des Acacias
Cucq, France, 62780
Clinique Pasteur
Guilherand Granges, France, 07500
Centre Oscar Lambret
Lille, France, 59000
Centre Léon Bérard
Lyon, France, 69008
Hôtel Dieu
Lyon, France, 69002
Institut Paoli Calmettes
Marseille, France, 13009
Centre Val d'Aurelle
Montpellier, France, 34005
Centre Hospitalier Lyon Sud
Pierre Benite, France, 69495
CH Arrondissement Montreuil sur Mer
Rang Du Fliers, France, 62180
Centre Eugène Marquis
Rennes, France, 35042
Centre Henri Becquerel
Rouen, France, 76038
Centre René Huguenin
Saint Cloud, France, 92210
CHRU Saint Etienne
Saint Etienne, France, 42055
Centre René Gauducheau
Saint Herblain, France, 44805
CMCO
Saint Martin Boulogne, France, 62280
Institut Claudius Régaud
Toulouse, France, 31052
Centre Alexis Vautrin
Vandoeuvre Les Nancy, France, 54511
Sponsors and Collaborators
Centre Leon Berard
PHRC 2007: financial support
Investigators
Principal Investigator: Hervé MIGNOTTE, MD Centre Leon Berard, Lyon
  More Information

Publications:
Edwards M, Giuliano A, Reintgen D, Tafra L. Consensus statement on guidelines for performance of sentinel lymph node biopsy for breast cancer. Am Soc Breast Surg Q. Press Release, 1998 ;Fall :3

Responsible Party: Centre Leon Berard
ClinicalTrials.gov Identifier: NCT00636467     History of Changes
Other Study ID Numbers: GAS2PLUS, ET2007-045
Study First Received: February 8, 2008
Last Updated: September 25, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Centre Leon Berard:
Breast cancer (tumors> 2 cm)
Detection
Axillary sentinel lymph node

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases

ClinicalTrials.gov processed this record on October 23, 2014