Sentinel Lymph Node After Neoadjuvant Chemotherapy in Breast Carcinoma
NCT ID: NCT03630913
Last Updated: 2022-04-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
385 participants
INTERVENTIONAL
2019-01-08
2023-10-31
Brief Summary
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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.
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Detailed Description
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The diagnostic performances of this strategy will be primarily assessed by the decrease of the FNR with the combined strategy compared to SLND alone.
The primary objective is to evaluate the interest of identifying, before NAC, the initial involved lymph node to improve the prediction of axillary status after NAC.
The main secondary objectives are :
* To assess the feasibility, at the time of the surgery, of the identification and resection of the initially involved lymph node, tagged with the metal clip before NAC ;
* To evaluate the complications related to the setting up of the metal clip for the identification of a lymph node metastatic ;
* To evaluate the interest and impact of immunohistochemical analysis of tagged lymph node and SLN ;
Patients treated for a large early breast cancer (BC) needing NAC undergo axillary sonography assessment routinely performed to seek suspicious nodes. When several suspicious nodes are found only the worst is chosen. A fine needle aspiration is performed to allow cytological examination (biopsy is optional) of the suspicious node. In case of proven axillary involvement, the patient is informed about GANEA 3 study in order to be included.
At this step the patient must accept the study and sign the consent form. The involved node is then tagged (with a metal clip) under sonography. In case of multiple suspicious nodes, the radiologist must choose the worst node in order to tag only one involved node.
Then, then patients will perform their chemotherapy. The choice of NAC regimen is let at the discretion of each participating team.
After NAC, breast tumor size and axillary assessment are performed.
Breast and axillary surgery are performed during the same procedure, 4 to 6 weeks after completion of NAC. Breast surgery can be conservative or radical.
All patients undergo the resection of the tagged axillary node, SLN biopsy and a complementary axillary lymphadenectomy.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Tagged axillary metastatic node
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.
Tagged axillary metastatic node
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.
Interventions
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Tagged axillary metastatic node
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.
Eligibility Criteria
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Inclusion Criteria
2. Initial diagnosis of operable invasive breast carcinoma
3. Histologically proven axillary metastasis (cytology or biopsy) before NAC
4. Patient included in a therapeutic approach of neoadjuvant chemotherapy
5. Procedure for the detection of sentinel lymph node by isotopic method +/- colorimetric
6. Information of the patient and obtaining written consent, signed by the patient and the investigator
7. Affiliated patient or beneficiary of the social security
Exclusion Criteria
2. Metastatic breast cancer
3. Any prior chemotherapy for contralateral breast cancer
4. Local relapse of breast cancer
5. Axillary metastasis not histologically proven before NAC
6. Allergy known to the 2 detection products (Blue and radioactive tracer)
7. Pregnant or lactating woman
8. Neo Adjuvant chemotherapy contraindicated
9. Patient protected or under guardianship or unable to give consent
10. Impossibility of submitting to the medical examination for geographical, social or psychological
18 Years
FEMALE
No
Sponsors
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Direction Générale de l'Offre de Soins
OTHER_GOV
Institut Cancerologie de l'Ouest
OTHER
Responsible Party
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Principal Investigators
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JEAN-MARC CLASSE, MD
Role: STUDY_DIRECTOR
ICO NANTES
Locations
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ICO - Site ANGERS
Angers, , France
Institut Bergonié
Bordeaux, , France
CHU Brest
Brest, , France
Centre Jean Perrin
Clermont-Ferrand, , France
Centre Georges Francoise Leclerc
Dijon, , France
Oscar Lambret
Lille, , France
Centre Léon Bérard
Lyon, , France
Institut Paoli Calmettes
Marseille, , France
Institut de Cancérologie de Montpellier
Montpellier, , France
APHP - Pitié Salpétrière
Paris, , France
Hôpital St JOSEPH
Paris, , France
Anne-Sophie Georges BATS
Paris, , France
Centre Jean Godinot
Reims, , France
CURIE
Saint-Cloud, , France
CHP St GREGOIRE
Saint-Grégoire, , France
Céline RENAUDEAU
Saint-Herblain, , France
IUCT-O
Toulouse, , France
Institut de Cancérlogie de Lorraine
Vandœuvre-lès-Nancy, , France
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Other Identifiers
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ICO-N-2018-03
Identifier Type: -
Identifier Source: org_study_id
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