Sentinel Lymph Node Detection After Neoadjuvant Chemotherapy for Large Operable Breast Cancer (GANEA2)

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

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Procedure: Axillar Sentinel lymph node biopsy; Procedure: SLNB and complete level I-II axillary lymphadenectomy

• Study Type: Interventional
• Enrollment (Actual): 958
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Angers, France, 49055
    • Institut de cancerologie de l'ouest
  • Angers, France, 49 933
    • CHU
  • Bordeaux, France, 33000
    • Institut Bergonie
  • Brest, France, 29609
    • CHU
  • Clermont Ferrand, France
    • Centre Jean Perrin
  • La Roche-sur-Yon, France, 85925
    • CH
  • Lille, France, 59000
    • Centre Oscar Lambret
  • Lyon, France, 69 000
    • Centre Leon Berard
  • Marseille, France, 13009
    • Institut Paoli Calmette
  • Montpellier, France, 34298
    • Institut de Cancérologie de Montpellier Val d'Aurelle
  • Nancy, France, 54511
    • Institut de Cancérlogie de Lorraine
  • Paris, France, 75908
    • HEGP
  • Paris, France, 75000
    • Hôpital Lariboisière
  • Paris, France, 75000
    • Hôpital Européen Georges Pompidou
  • Paris, France, 75 000
    • Institut Curie
  • Saint Herblain, France, 44805
    • Institut de cancerologie de l'ouest
  • Saint-Cloud, France, 92210
    • Institut Curie
  • Strasbourg, France
    • ICANS

Participation Criteria

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:

• T2-T3 operable infiltrating breast carcinoma
• No allergy to Patent Blue
• Pre-operative diagnosis of unifocal infiltrating breast carcinoma.
• Patient planned to be treated by NAC.
• Informed consent.
• Surgery available 4 to 6 weeks after the last chemotherapy course (radical or conservative surgery)

Exclusion Criteria:

• pT4d (inflammatory breast cancer)
• Locally advanced or metastatic breast cancer
• Any previous chemotherapy of contra-lateral breast cancer.
• Breast cancer local relapse
• Previous surgical removal of breast Cancer.
• Inadequate biopsy for pathological analysis.
• Dementia or altered mental disorder
• Pregnant woman or breast feeding or without efficacious contraceptive method.
• Contra-indication to NAC NAC interrupted due to progressive disease.
• Neoadjuvant radiotherapy.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: group 2 (cN0); Patients without proven axillary involved nodes will undergo SLN biopsy and a complete axillary level I-II lymphadenectomy only in the case of detection failure or involved SLN and a SLN biopsy 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: 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.
Experimental: group 1 (pN+); group 1 : patients with proven involved axillary nodes will undergo SLN biopsy and complete level I-II axillary 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
false-negative (FN) rate for the Sentinel Lymph Node Detection	Ratio of the number of FN cases to the total number of patients with at least one lymph node involved, sentinel or not. a FN case was defined as a patient with a successful mapping, SLN(s) without any metastasis, and a metastasis in at least one node from the ALND	after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Detection rate	Percentage of patients with SLN detected and isolated intraoperatively	after surgery
Sataloff score on breast tumour	The Sataloff classification assesses the response of the NAC on the breast tissue. TA: total or almost total therapeutic effect. TB: therapeutic effect > 50%. TC: < 50% therapeutic effect but obvious effect. TD: no therapeutic effect	after surgery
Sataloff score on lymph nodes	The Sataloff classification assesses the response of the NAC on the lymph nodes NA: clear therapeutic effect, no metastases. NB: no therapeutic effect, no metastases. NC: aspects of therapeutic effect, but presence of metastases. ND: no therapeutic effect, viable metastases.	after surgery
Homolateral axillary recurrence rate	Recurrence observed groupe 2 patients (cN0) whitout ALND	5 years post surgery

Collaborators and Investigators

• Sponsor: Institut Cancerologie de l'Ouest
• Investigators: Principal Investigator: Jean-Marc CLASSE, MD, Institut de cancerologie de l'ouest

Study record dates

Study Major Dates

• Study Start (Actual): July 12, 2010
• Primary Completion (Actual): October 27, 2014
• Study Completion (Actual): December 10, 2019

Study Registration Dates

• First Submitted: October 11, 2010
• First Submitted That Met QC Criteria: October 14, 2010
• First Posted (Estimate): October 15, 2010

Study Record Updates

• Last Update Posted (Actual): April 25, 2022
• Last Update Submitted That Met QC Criteria: April 19, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Breast cancer; neoadjuvant chemotherapy; Sentinel lymph node; Axillary lymph node dissection; False negative rate
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: BRD 09/9-G