NCT03630913

Brief Summary

Sentinel lymph node dissection (SLND) after NAC, aimed to reduce the rate of unnecessary axillary lymphadenectomy, is not a standard of care in case of patient with previously involved node before NAC because of a too high false negative rate (FNR). Clinical consequences of FNR of SLND after NAC are currently unknown. Consequently, contrary to adjuvant setting, a risk of SLND false negative case after NAC is not acceptable. GANEA3 aims to evaluate the results of an innovative multiparametric strategy combining (1) an identification before chemotherapy of a lymph node involvement using a metal clip and then its analysis after treatment, (2) the analysis of sentinel lymph node (SLN) after NAC, and (3) analysis of biological parameters of breast tumor before and after NAC, to predict axillary status after NAC. This will identify patients with initial lymph node involvement who could benefit from SLN after NAC without additional axillary dissection with a very low FNR (≤1%). The most "pathological" metastatic lymph node will be identified with a metal clip under ultrasound. They will then receive a NAC before breast and axillary surgery. An assessment of the NAC response at the breast and axillary will be performed by imagery. Then, all patients undergo the resection of the tagged axillary node with the metal clip, SLN detection and biopsy and a complementary axillary lymphadenectomy.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
385

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

18 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 10, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 15, 2018

Completed
5 months until next milestone

Study Start

First participant enrolled

January 8, 2019

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2023

Completed
Last Updated

April 22, 2022

Status Verified

April 1, 2022

Enrollment Period

4.7 years

First QC Date

August 10, 2018

Last Update Submit

April 21, 2022

Conditions

Invasive Breast CancerAxillary Metastases

Keywords

Neoadjuvant chemotherapySentinel lymph nodeAxillary lymphadenectomyTagged axillary metastatic node

Outcome Measures

Primary Outcomes (1)

  • False negative rate

    number of cases of false prediction of absence of lymph node involvement to the total number of cases with metastatic lymph node. The rate of FN will be calculated for the involved lymph node tagged with the metal clip, the sentinel node, and the both

    30 days after surgery

Secondary Outcomes (3)

  • Identification rate of involved lymph node tagged

    30 days after surgery

  • Resection rate of involved lymph node tagged

    30 days after surgery

  • Complication rate

    30 days after surgery

Study Arms (1)

Tagged axillary metastatic node

EXPERIMENTAL

Patients undergo axillary sonography assessment routinely performed to seek suspicious nodes. A cytological examination (biopsy is optional) of the suspicious node is performed. The involved node is then tagged with a metal clip under sonography. Then, patients receive NAC before surgery. Breast surgery (conservative or radical) and axillary surgery are performed during the same procedure, 4 to 6 weeks after completion of NAC.

Procedure: Tagged axillary metastatic node

Interventions

Tagged axillary metastatic nodePROCEDURE

First, initially metastatic lymph node is tagged with a metal clip under sonography. Then, patients receive NAC before surgery. Breast surgery (conservative or radical) and axillary surgery are performed during the same procedure, 4 to 6 weeks after completion of NAC. SLN isotope detection is performed with or without blue dye. All patients undergo the resection of the tagged axillary node, SLN biopsy and a complementary axillary lymphadenectomy.

Tagged axillary metastatic node

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients ≥ 18 years old
  • Initial diagnosis of operable invasive breast carcinoma
  • Histologically proven axillary metastasis (cytology or biopsy) before NAC
  • Patient included in a therapeutic approach of neoadjuvant chemotherapy
  • Procedure for the detection of sentinel lymph node by isotopic method +/- colorimetric
  • Information of the patient and obtaining written consent, signed by the patient and the investigator
  • Affiliated patient or beneficiary of the social security

You may not qualify if:

  • pT4d (inflammatory breast cancer)
  • Metastatic breast cancer
  • Any prior chemotherapy for contralateral breast cancer
  • Local relapse of breast cancer
  • Axillary metastasis not histologically proven before NAC
  • Allergy known to the 2 detection products (Blue and radioactive tracer)
  • Pregnant or lactating woman
  • Neo Adjuvant chemotherapy contraindicated
  • Patient protected or under guardianship or unable to give consent
  • Impossibility of submitting to the medical examination for geographical, social or psychological

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (18)

ICO - Site ANGERS

Angers, 49055, France

SUSPENDED

Institut Bergonié

Bordeaux, 33076, France

SUSPENDED

CHU Brest

Brest, 29609, France

SUSPENDED

Centre Jean Perrin

Clermont-Ferrand, 63011, France

RECRUITING

Centre Georges Francoise Leclerc

Dijon, 21079, France

RECRUITING

Oscar Lambret

Lille, France

SUSPENDED

Centre Léon Bérard

Lyon, 69373, France

RECRUITING

Institut Paoli Calmettes

Marseille, 13009, France

RECRUITING

Institut de Cancérologie de Montpellier

Montpellier, 34298, France

RECRUITING

APHP - Pitié Salpétrière

Paris, 75013, France

SUSPENDED

Hôpital St JOSEPH

Paris, 75014, France

SUSPENDED

Anne-Sophie Georges BATS

Paris, 75908, France

SUSPENDED

Centre Jean Godinot

Reims, 51726, France

SUSPENDED

CURIE

Saint-Cloud, 92210, France

RECRUITING

CHP St GREGOIRE

Saint-Grégoire, 35760, France

SUSPENDED

Céline RENAUDEAU

Saint-Herblain, 44805, France

RECRUITING

IUCT-O

Toulouse, 31059, France

SUSPENDED

Institut de Cancérlogie de Lorraine

Vandœuvre-lès-Nancy, 54511, France

RECRUITING

Related Publications (1)

  • Ditsch N, Rubio IT, Gasparri ML, de Boniface J, Kuehn T. Breast and axillary surgery in malignant breast disease: a review focused on literature of 2018 and 2019. Curr Opin Obstet Gynecol. 2020 Feb;32(1):91-99. doi: 10.1097/GCO.0000000000000593.

    PMID: 31833973DERIVED

Study Officials

  • JEAN-MARC CLASSE, MD

    ICO NANTES

    STUDY DIRECTOR

Central Study Contacts

JEAN-MARC CLASSE, MD

CONTACT

+33240679910Jean-Marc.Classe@ico.unicancer.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 10, 2018

First Posted

August 15, 2018

Study Start

January 8, 2019

Primary Completion

October 1, 2023

Study Completion

October 1, 2023

Last Updated

April 22, 2022

Record last verified: 2022-04

Locations

FR(18)