Neoplasms

All Conditions

Skin and Connective Tissue Diseases

Symptoms and General Pathology

Carcinoma

Breast Neoplasms

Neoplasm Metastasis

Breast Diseases

Skin Diseases

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.

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

JEAN-MARC CLASSE, MD

Pierre GUIMBERGUES, MD

Pierre GIMBERGUES, MD

Clémentine JANKOWSKI, MD

Centre L Bérard, MD

Christelle FAURE, MD

Monique COHEN, MD

GUTOWSKI Marian, MD

Marian GUTOWSKI, MD

Céline RENAUDEAU, MD

Eugénie GUILLOT

Eugénie GUILLOT, MD

Philippe RAUCH, MD

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.

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.

Sentinel Lymph Node After Neoadjuvant Chemotherapy in Breast Carcinoma

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

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

number of cases where the tagged lymph node is resected during axillary surgery and analyzed in pathology on the total number of procedures

number of complications related to the axillary lymph node tagging procedure on the total number of procedures

Direction Générale de l'Offre de Soins

Institut Cancerologie de l'Ouest

Lymphatic Metastasis

Neoplastic Processes

Ultrasound of the axilla preoperative. Clipped biopsy proven positive node. I125 radioactive seed before surgery. Sentinel node biopsy using Tc99 +/- blue dye. Targeted Axillary Node Dissection performed at surgery

Sentinel Node Biopsy (SNB; using Tc99 +/- Blue dye) + Radioactive Seed Localisation (RSL) of clipped node using I125 seed = Targeted Axillary Dissection (TAD)

Targeted Axillary Dissection

Prospectively recorded preoperative ultrasound of the axilla. Number of suspicious nodes recorded. Biopsy and clipping of the positive node.

Ultrasound of the axilla

Jean-François Boileau, MD,MSc,FRCSC

Léamarie Meloche-Dumas, MD

Lucas Sidéris, MD

Erica Patocskai, MD

Isabelle Trop, MPH,FRCPC

Danh Tran-Thanh, MD,MSc,FRCPC

Mona El Khoury, MD

Stephanie Wong, MD,MPH,FRCSC

Francesca Marie Grazia Proulx, MD

Livia Florianova, MD,MSc,FRCPC

RATIONALE: It is now standard for most breast cancer patients with 1-2 positive sentinel nodes to avoid completion node dissection when eligibility criteria from the American College of Surgeons Oncology Group (ACOSOG) Z0011 trial are met. The National Comprehensive Cancer Network (NCCN) recently proposed to extend this indication to patients that present with biopsy proven node positive disease if only 1 or 2 suspicious nodes are found on imaging, these positive nodes are not palpable clinically, and the other eligibility criteria from the Z0011 study are otherwise met. However, this recommendation is based on an expert consensus and no study has yet confirmed the optimal method to stage the axilla in this patient population.

PURPOSE: Evaluate the technical success rate and accuracy of sentinel node biopsy (SNB) and the potential benefits of clipping and removing the biopsy proven node using radioactive seed localisation (RSL) (SNB+RSL = Targeted Axillary Dissection (TAD)) in patients with biopsy proven positive nodes, limited nodal disease in imaging and clinically negative axillary examination.

This is a prospective multicenter study. Patients with T1-2 Breast cancer and clinically negative axilla on palpation, 1-2 suspicious nodes on ultrasound, and a biopsy proven positive node (by core biopsy of fine needle aspiration) will have a radioactive seed (I125) placed in their clipped node before surgery. At the time of surgery, patients that are scheduled for breast conserving surgery or mastectomy will have sentinel node biopsy (SNB) using radioactive dye (Tc99) +/- blue dye as well as retrieval of the clipped node using radioactive seed localisation (RSL). Removal of the I125 radioactive seed in the clipped node will be performed before the Tc99 counts are performed to prevent "shine through" and biased measurements. Imaging of the surgical specimen will confirm retrieval of the clipped node. Prospectively recorded information on pre-operative axillary imaging, characteristics of the retrieved nodes in the operating room and detailed pathological analysis of each corresponding node will be performed. Completion node dissection (CND) is not mandatory in this study but recommended if the clipped positive node is not retrieved, if 4 nodes or more are positive or if 3 nodes are positive in the absence of axillary radiation. The benefits of adding RSL to SNB and the benefits of adding SNB to RSL staging of the axilla will be evaluated in this study and will help to better define the value of using TAD in this patient population.

Targeted Axillary Dissection (TAD) in Early-stage Node Positive Breast Cancer

Sentinel Node Biopsy and Targeted Axillary Dissection in Node-Positive Breast Cancer Patients With Clinically Negative Axilla

Recommended completion node dissection rate (CND) = false negative rate (FNR) + technical failure rate (TFR).

TAD CND (TAD FNR + TAD TFR) vs. SNB CND (SNB FNR + SNB TFR)

Evaluate if the addition of SNB to RSL improves the ability to identify patients with 3+ positive nodes that do not otherwise meet the ACOSOG Z0011 criteria and require further regional axillary therapy

Percentage of patients with successful removal of at least one node (using this method) where at least one positive node was not retrieved (using this method)

Percentage of patients with unsuccessful removal of at least one node using this method, including the clipped node

Percentage of patients with unsuccessful removal of at least one node using this method (clipped node or not)

Quebec Breast Cancer Foundation

Jewish General Hospital

MD, MSc, FRCSC, Surgical Oncologist, Associate Professor Surgery and Oncology, McGill University, Director JGH Breast Clinical Trials Group

Skin Neoplasms

Central Nervous System Depressants

All Drugs and Chemicals

Anesthetics

Anesthetics, Local

Hypnotics and Sedatives

Serratus plane block plus intravenous sedation as anesthetic technique during axillary dissection procedure.

Ultrasound guided injection of local anesthetic between latissimus dorsi and serratus muscles at mid axillary line.

Serratus plane block

Axillary dissection is a surgical procedure that incises the axilla to identify, examine, or remove lymph nodes.

Axillary dissection

Administration of sedatives thru an intravenous access to achieve relaxion and improve operative conditions.

Intravenous sedation

Daniele Theobald, MD

INTRODUCTION: The axillary lymphadenectomy procedure is known to be associated with late postoperative complications, such as chronic pain and changes in shoulder mobility. Recently, several thoracic ultrasound guided interfascial blocks have been described, including serratus plane block. These blocks were associated with reduced postoperative pain scores in breast surgeries but were never evaluated in axillary dissection. The safety and feasibility of performing axillary dissection under local anesthesia and tumescent anesthesia associated with sedation has been demonstrated in case series, although it is not already the standard technique.

DISCUSSION: This project aims to investigate the feasibility of the serratus plane block associated with intra-venous sedation in a prospective case series including 15 patients submitted to axillary dissection, by scoring patient and surgeon satisfaction with the technique, pain, quality of life with EORTC QLQ-C30 questionnaire, and quality of recovery with QoR-40 questionnaire in the first 30 postoperative days.

This study is a prospective case series. All patients should go through a preoperative evaluation with an anesthesiologist. At that time the eligibility for the study will be evaluated and if the patient consent to participate in the study.

The following parameters shall be evaluated in the ambulatory evaluation:

* Age
* Anthropometric data (weight and height);
* Presence of comorbidities;
* Revised cardiac index (LEE);
* Estimation of functional capacity in metabolic equivalents (METs) by history;
* Performance Status by the scale of Eastern Cooperative Oncology Group (ECOG);
* Determination of the physical status by the American Society of Anesthesiologists (ASA) classification;
* QoR-40 recovery quality scale, validated for Brazilian Portuguese;
* Quality of life EORTC QLQ-C30 questionnaire, validated for Brazilian Portuguese.

During the anesthetic procedure, the following standard technique should be applied: peripheral venous access, dipyrone 30 mg/kg, antibiotic according to the institutional protocol, moderate sedation with intravenous propofol in continuous infusion in the absence of any contraindication. Midazolam will be used in case of contraindication to propofol or during the execution of the block according to preference of the researcher who will perform the block. Associated with propofol infusion, the alpha agonist dexmedetomidine may be used in continuous infusion associated with fentanyl, tramadol, dextroketamine, magnesium sulfate, dipyrone and tenoxicam, whose uses will be evaluated on a case-by-case basis and will be recorded in the database.

In case of conversion to general anesthesia, the airway control should be carried out preferably with laryngeal mask, with the orotracheal intubation as an alternative option. The maintenance of anesthesia will be in this case using propofol continuous infusion in the absence of contraindications, otherwise sevoflurane will be used. Postoperative nausea and vomiting prophylaxis will be done with four milligrams of dexamethasone and ondansetron.

Patients will be submitted serratus plane block according to the technique described in Blanco. The patients will be positioned in a supine position. The transducer of the ultrasound device is protected with sterile cover. The ultrasound probe is positioned in the mid clavicular region of the thoracic wall in a sagittal plane. Using a nether-lateral path with the probe, will be counted the ribs, until the fifth rib is identified in the mid axillary line. In this position, over the fifth rib, the latissimus dorsi muscle superficially and the serratus muscle deeper and lower can be easily observed. The identification of the thoracodorsal artery with use of doppler imaging assists in identifying the superficial plane to the serratus muscle. Once identified the structures, the needle is introduced in the plane of the transducer positioning its tip on the surface of the serratus muscle. Then 40 ml of solution with 1% lidocaine, adrenaline 1:200,000 and ropivacaine 0.5% are injected in patients above 50kg and 32ml of the same solution in patients with body weight between 40 and 50kg aiming to respect the maximum dose of local anesthetic recommended.

At the end of the surgical procedure the patient will be referred to the anesthetic recovery unit. The extension of the blockade will be then evaluated. They will be discharged to ward as soon as they get the discharge criteria.

The surgical time, time for execution of the blockage (counted from the placement of the sterile field until the removal of the needle), the surgical room time, estimated bleeding, presence of surgical complications or anesthetic and number of lymph nodes extracted will be registered. At the end of the surgery the surgeon will be asked to fill out a range of Likert 5 points on his opinion on the quality of anesthesia (extremely satisfied, satisfied, not satisfied or dissatisfied, dissatisfied, extremely dissatisfied) and to compare the quality of anesthesia with general anesthesia on a 3-point scale (indistinguishable from general anesthesia, sufficient to perform the procedure, extremely challenging/inadequate).

On the first day of postoperative the standard analgesia will be carried out with dipyrone 30 mg/kg IV every 4 hours, associated with tenoxicam 20mg every 12 hours. In case of contraindication to dipyrone, will be administered paracetamol 500 mg VO every 6 hours. As a rescue therapy the default option is tramadol 50mg IV up to every 4 hours (daily maximum dose of 300mg/day and morphine 4 mg each hour (in case of allergy or intolerance to tramadol and rescue the tramadol). If necessary more than 24 hours of hospitalization, postoperative analgesia will be performed as option of the assistant team. The use of postoperative painkillers will be recorded in the database.

All patients should be evaluated on the first postoperative day with record of the verbal numerical scale for the evaluation of pain at rest, cough and abduction of 90 Degrees of the member and the presence of adverse effects. They be asked to fill the scale of Likert of 5 points with his opinion on the quality of anesthesia (extremely satisfied, satisfied, neither satisfied nor dissatisfied, dissatisfied, extremely dissatisfied) and the scale of recovery quality QoR-40. Between the twenty-eighth and the thirtieth-fifth postoperative day All patients will be reassessed, occasion where the scale of recovery quality QoR-40 and the scale of quality of life EORTC QLQ-C30, presence of surgical wound infection will be applied, cutaneous necrosis, seroma, lymphedema, lymphatic fistula and date of drain removal.

Feasibility of Serratus Plane Block Associated With Sedation in Axillary Dissection

Assessment of the Feasibility of Ultrasound Guided Serratus Plane Block Associated With Sedation as Anesthetic Technique in Axillary Dissection

Percentage of patients who needed conversion to general anesthesia. A percentage from 0 to 100%, where 0% means that no patient needs technique conversion to general anesthesia and 100% means that all patients need it.

The QLQ-C30 is composed of multi-item scales and single-item measures. These include:

* A global health status / QoL scale
* Five functional scales (Physical functioning, Role functioning, Emotional functioning, Cognitive functioning, Social functioning)
* Three symptom scales (Fatigue, Nausea and vomiting, Pain)
* Six single items (Dyspnoea, Insomnia, Appetite loss, Constipation, Diarrhoea, Financial difficulties) Each of the multi-item scales includes a different set of items. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. Thus a high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / QoL represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems . The scales are scored as described as described in EORTC QLQ-C30 Scoring Manual. 2001 EORTC, Brussels.

Quality of Recovery - 40 Item questionnaire

QoR-40 score is a score developed to estimate the quality of recovery after anesthesia. It consists of a 40-item questionnaire with items on a five- point Likert scale (for positive items, 1 'none of the time' to 5 'all of the time'; for negative items the scoring was reversed). It is scored as follows:

QoR-40 dimensions

* Emotional state (9-45)
* Physical comfort (12-60)
* Psychological support (7-35)
* Physical independence (5-25)
* Pain (7-35) Global QoR-40 (40-200)

A five points Likert scale will be applied to the main surgeon responsible for the operation.

The surgeon will be asked to fill out a Likert 5 points scale to access his opinion about the quality of anesthesia (extremely satisfied, satisfied, not satisfied or dissatisfied, dissatisfied, extremely dissatisfied).

A five points Likert scale will be applied to the patient in the first postoperative day visit to access his opinion about the quality of the anesthesia (extremely satisfied, satisfied, neither satisfied nor dissatisfied, dissatisfied, extremely dissatisfied).

Eleven point numeric pain rating scale (0 means no pain and 10 means worst possible pain).

All the anesthetics and analgesics used in intraoperative and postoperative period will be recorded. Doses will be recorded in database.

Number of lymph nodes extracted according to anatomopathological report.

Instituto Nacional de Cancer, Brazil

Use of ICG during the targeted axillary dissection (TAD)

Targeted axillary dissection (TAD) by ICG

Use of Blue patent during the targeted axillary dissection (TAD)

Targeted axillary dissection (TAD) by Blue patent

Amparo Garcia-Tejedor

Amparo Garcia-Tejedor, MDPhD

Carlos Ortega-Expósito

To validate the use of ICG as a tracer during TAD in patients with cN1 breast carcinoma after neoadjuvant chemotherapy.

ICG vs Blue Patent as a Tracer in the Performance of TAD in Patients With cN1 Breast Carcinoma After Neoadjuvant Chemotherapy

Compare the detection rate of sentinel lymph node between ICG and blue patent in cN+ patients after neoadjuvant treatment

Compare the detection rate of sentinel lymph node between ICG and Tc99 in cN+ patients after neoadjuvant treatment

Evaluate the adverse effects from the use of each of the tracers

Hospital Universitari de Bellvitge

Principal Investigator

Jianguo Lai, M.D.

Jianguo Lai, M.D

Fengyan Yu, M.D,PHD

Fengyan Yu, M.D.,Ph.D

Axillary lymph node status is a vital prognostic factors in breast cancer patients and provides crucial information for making treatment decisions.This projective observational study is planned to identify risk factors for axillary metastases in breast cancer patients with axillary ultrasound and to construct a nomogram to predict the risk of axillary metastases in these patients.

Breast carcinoma is the most common malignancy in women, accounting for 25% of all female cancer cases and 15% of all cancer-related deaths in the world.Lymph node metastasis is a multifactorial event. Among patients with a preoperative axillary ultrasound, almost 40% of patients are pathologically proved to be free from axillary metastasis.The purpose of this study is to develop a nomogram to evaluate the probability of axillary metastasis as a tool to support clinical decision-making.

Predict the Risk of Axillary Metastases in Breast Cancer Patients With Axillary Ultrasound

A Nomogram to Predict the Risk of Axillary Metastases in Breast Cancer Patients With Axillary Ultrasound

Surgical treatment for breast cancer patients include breast-conserving surgery or mastectomy with or without breast reconstruction. Intraoperative ALND is carried out when the SLNs are positive by intraoperative frozen section. Post-operative H\&E permanent staining is administered to confirm the results of the frozen section. Serial H\&E and immunohistochemistry stain (IHC) are only carried out when axillary metastases are not visible after H\&E staining.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Sentinel Lymph Node After Neoadjuvant Chemotherapy in Breast Carcinoma	NCT03630913	Invasive Breast... Axillary Metast...	Tagged axillary...	18 Years -	Institut Cancerologie de l'Ouest
Targeted Axillary Dissection (TAD) in Early-stage Node Positive Breast Cancer	NCT04671511	Breast Cancer F... Early-stage Bre... Lymph Node Meta... Axillary Metast... Sentinel Lymph ...	Targeted Axilla... Ultrasound of t...	18 Years -	Jewish General Hospital
Feasibility of Serratus Plane Block Associated With Sedation in Axillary Dissection	NCT03740815	Anesthesia Regional Anesth... Axillary Metast... Nerve Block Analgesia Skin Cancer	Serratus plane ... Axillary dissec... Intravenous sed...	18 Years -	Instituto Nacional de Cancer, Brazil
ICG vs Blue Patent as a Tracer in the Performance of TAD in Patients With cN1 Breast Carcinoma After Neoadjuvant Chemotherapy	NCT06339658	Breast Cancer Axillary Metast...	Targeted axilla... Targeted axilla...	18 Years -	Hospital Universitari de Bellvitge
Targeted Axillary Dissection (TAD) in Early-stage Node Positive Breast Cancer	NCT04671511	Breast Cancer F... Early-stage Bre... Lymph Node Meta... Axillary Metast... Sentinel Lymph ...	Targeted Axilla... Ultrasound of t...	18 Years -	Jewish General Hospital
Predict the Risk of Axillary Metastases in Breast Cancer Patients With Axillary Ultrasound	NCT02992769	Breast Cancer F...		18 Years - 70 Years	Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Sentinel Lymph Node After Neoadjuvant Chemotherapy in Breast Carcinoma	NCT03630913	Invasive Breast... Axillary Metast...	Tagged axillary...	18 Years -	Institut Cancerologie de l'Ouest
ICG vs Blue Patent as a Tracer in the Performance of TAD in Patients With cN1 Breast Carcinoma After Neoadjuvant Chemotherapy	NCT06339658	Breast Cancer Axillary Metast...	Targeted axilla... Targeted axilla...	18 Years -	Hospital Universitari de Bellvitge
Feasibility of Serratus Plane Block Associated With Sedation in Axillary Dissection	NCT03740815	Anesthesia Regional Anesth... Axillary Metast... Nerve Block Analgesia Skin Cancer	Serratus plane ... Axillary dissec... Intravenous sed...	18 Years -	Instituto Nacional de Cancer, Brazil

Spots Global Cancer Trial Database for axillary metastases