Invasive Breast CancerGANEA3NCT03630913
Sentinel Lymph Node After Neoadjuvant Chemotherapy in Breast Carcinoma
A study testing Tagged axillary metastatic node in people with Invasive Breast Cancer and Axillary Metastases, run by Institut Cancerologie de l'Ouest at 18 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Invasive Breast Cancer, Axillary Metastases
- What is being tested?
- Tagged axillary metastatic node
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 385 participants
- Where
- 18 sitesFrance
- Study dates
- 8 Jan 2019to Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 10Show fewer
- 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
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
France18 sites, 8 recruiting
- Suspended
ICO - Site ANGERS
Angers, 49055
- Suspended
Institut Bergonié
Bordeaux, 33076
- Suspended
CHU Brest
Brest, 29609
- Recruiting
Centre Jean Perrin
Clermont-Ferrand, 63011
Pierre GUIMBERGUES, MD, pierre.gimbergues@cjp.fr
Pierre GIMBERGUES, MD
- Recruiting
Centre Georges Francoise Leclerc
Dijon, 21079
Clémentine JANKOWSKI, MD, cjankowski@cgfl.fr
Clémentine JANKOWSKI, MD
- Suspended
Oscar Lambret
Lille
- Recruiting
Centre Léon Bérard
Lyon, 69373
Centre L Bérard, MD, christelle.faure@lyon.unicancer.fr
Christelle FAURE, MD
- Recruiting
Institut Paoli Calmettes
Marseille, 13009
Monique COHEN, MD, cohenm@ipc.unicancer.fr
Monique COHEN, MD
- Recruiting
Institut de Cancérologie de Montpellier
Montpellier, 34298
GUTOWSKI Marian, MD, marian.gutowski@icm.unicancer.fr
Marian GUTOWSKI, MD
- Suspended
APHP - Pitié Salpétrière
Paris, 75013
- Suspended
Hôpital St JOSEPH
Paris, 75014
- Suspended
Anne-Sophie Georges BATS
Paris, 75908
- Suspended
Centre Jean Godinot
Reims, 51726
- Recruiting
CURIE
Saint-Cloud, 92210
Eugénie GUILLOT, eugenie.guillot@curie.fr
Eugénie GUILLOT, MD
- Suspended
CHP St GREGOIRE
Saint-Grégoire, 35760
- Recruiting
Céline RENAUDEAU
Saint-Herblain, 44805
Céline RENAUDEAU, MD, +33240679900, celine.renaudeau@ico.unicancer.fr
Céline RENAUDEAU, MD
- Suspended
IUCT-O
Toulouse, 31059
- Recruiting
Institut de Cancérlogie de Lorraine
Vandœuvre-lès-Nancy, 54511
Philippe RAUCH, MD, p.rauch@nancy.unicancer.fr
Philippe RAUCH, MD
About this study
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.
Read more
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.
Read the detailed description
GANEA3 is a prospective multicenter diagnostic study assessing the benefit of targeting initial involved node in complement to SLND and breast tumor characteristics to predict axillary status after NAC.
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
- Invasive Breast Cancer, Axillary Metastases
- Being tested
- Tagged axillary metastatic node
- Keywords
- Neoadjuvant chemotherapy, Sentinel lymph node, Axillary lymphadenectomy, Tagged axillary metastatic node
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tagged axillary metastatic nodeProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Tagged axillary metastatic node |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 30 days after surgery
Secondary outcomes (3)
Identification rate of involved lymph node tagged
number of cases where the tagged lymph node with a metal clip node is identified during axillary surgery and analyzed in pathology on the total number of procedures
Measured: 30 days after surgery
Resection rate of involved lymph node tagged
number of cases where the tagged lymph node is resected during axillary surgery and analyzed in pathology on the total number of procedures
Measured: 30 days after surgery
Complication rate
number of complications related to the axillary lymph node tagging procedure on the total number of procedures
Measured: 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2018
- Study start8 Jan 2019
- Primary completionOct 2023 (estimated)
- Study completionOct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Invasive Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 385 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Cancerologie de l'Ouest
- Sponsor type
- University, hospital or other
- Collaborators
- Direction Générale de l'Offre de Soins
- Responsible party
- Sponsor
- Investigators
- JEAN-MARC CLASSE, MD, Study director, ICO NANTES
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03630913
- Sponsor's protocol ID
- ICO-N-2018-03
- Acronym
- GANEA3
- Status last verified
- Apr 2022
- First submitted
- 10 Aug 2018
- Last updated
- 22 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 31833973
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sentinel Lymph Node After Neoadjuvant Chemotherapy in Breast Carcinoma
- ClinicalTrials.gov ID
- NCT03630913
- Acronym / sponsor ID
- GANEA3 / ICO-N-2018-03
- Conditions
- Invasive Breast Cancer, Axillary Metastases
- Keywords
- Neoadjuvant chemotherapy, Sentinel lymph node, Axillary lymphadenectomy, Tagged axillary metastatic node
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 385 participants (estimated)
- Lead sponsor
- Institut Cancerologie de l'OuestUniversity, hospital or other
- Collaborators
- Direction Générale de l'Offre de Soins
- Study start
- 8 Jan 2019 (actual)
- Primary completion
- Oct 2023 (estimated)
- Study completion
- Oct 2023 (estimated)
- First posted
- 15 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
GANEA3 is a prospective multicenter diagnostic study assessing the benefit of targeting initial involved node in complement to SLND and breast tumor characteristics to predict axillary status after NAC.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tagged axillary metastatic node | Experimental | Procedure: Tagged axillary metastatic nodePatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tagged axillary metastatic nodeFirst, 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. | Procedure or surgery | Tagged axillary metastatic node |
Primary outcome
False negative rate
Time frame: 30 days after surgery
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
3 secondary outcomes
Identification rate of involved lymph node tagged
Time frame: 30 days after surgery
Resection rate of involved lymph node tagged
Time frame: 30 days after surgery
Complication rate
Time frame: 30 days after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2022.
- Derived from this study: PubMed 31833973Ditsch 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.
Related trials for Invasive Breast Cancer
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
RecruitingPhase 2
BRE-04: Window of Opportunity Trial of Preoperative Low Dose Azacitidine in High-Risk Early Stage Breast Cancer
Breast Cancer Invasive, Early-stage Breast Cancer
RecruitingObservational study
Negative/Low Hormone Receptor And/or HER2 POsitive Lobular Invasive Breast Carcinoma - A Real-World International Cohort Study
Lobular Breast Carcinoma
RecruitingPhase 2
Testing the Addition of an Individualized Vaccine to Durvalumab and Tremelimumab and Chemotherapy in Patients With Metastatic Triple Negative Breast Cancer
Anatomic Stage IV Breast Cancer AJCC v8, Invasive Breast Carcinoma
RecruitingObservational study
Collecting Blood Samples From Patients With and Without Cancer to Evaluate Tests for Early Cancer Detection
Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
JEAN-MARC CLASSE, MD study director
ICO NANTES
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tagged axillary metastatic node in people with Invasive Breast Cancer and Axillary Metastases, run by Institut Cancerologie de l'Ouest at 18 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact JEAN-MARC CLASSE, MD (+33240679910, Jean-Marc.Classe@ico.unicancer.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
False negative rate (time frame: 30 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03630913, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2022.