Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

In the study arm will be omitted surgery in axilla

No axillary surgery

SLNB

Giuliano Duarte, MD, PhD

Danielle Cristina Myamoto de Araujo, MD

Francisco Pimentel Cavalcante

Leonardo R Soares, MD PhD

Rosemar Rahal, MD, PhD

Clécio Enio M de Lucena, MD PhD

René Aloisio C Vieira, MD PhD

Darley de Lima Ferreira Filho, MD

Vinícius Budel, MD PhD

Rafael Henrique S Machado, MD PhD

Roberta D Jales Alves de Andrade, MD

Andréa PS Damin, MD PhD

Idan Oliveira, MD PhD

Eduardo Pessoa, MD, PhD

Julio César N Gomes

Giuliano M Duarte, MD, PhD

Marcelo Antonini

The VENUS trial is a prospective, multicenter, noninferiority, randomized, controlled clinical trial that compares sentinel lymph node biopsy versus no axillary surgery in women with early breast cancer (tumor \<5cm) and node-negative after clinical palpation and axillary ultrasound.

The standard approach to women with early breast cancer (BC) and clinically negative nodes is sentinel lymph node dissection (SLND). Studies showed that axillary lymph node dissection (ALND) can be safely omitted in presence of positive sentinel lymph node in patients treated with breast conserving therapy.Therefore, the pertinence of SLND in the approach to women with early BC is being questioned, once it is not injury-free.

The ACOSOG Z0011 trial examined the safety of omitting ALND in patients with early BC and up to 2 positive nodes at SLND, undergoing conservative surgery plus breast radiotherapy. The 10-year worth of data from this trial strongly suggested that omitting the procedure in these restrict, well-selected, subsets of patients maybe safe. Neoadjuvant chemotherapy (NAC) may be the starting treatment step for women with aggressive BC subtypes even in early stages.The SENTINA and ACOSOG Z1071 trials revealed that for women with three or more negative nodes in SLND, the procedure's accuracy and false-negative rate lie within acceptable boundaries. Our hypothesis is that for patients with early BC (regardless of neoadjuvant systemic therapy), with clinically and ultrasound negative axilla, avoiding SLND may be safe from the oncological perspective.The VENUS trial will investigate whether there may be still room for further de-escalation of the approach to the axilla in well-selected subsets of BC patients, by including women for whom the de-escalation has not been tested in previous trials dealing with the subject.

The VENUS trial is a prospective, noninferiority, multicenter, randomized controlled clinical trial that was approved by the Local Research Ethic Committee .The trial will compare SLND with no axillary surgery in women with T1-2 invasive BC and N0 disease, as ascertained after clinical palpation and axillary ultrasound. Mastectomy and primary systemic therapy are allowed whether node negative previous start the treatment . All women accrued to the trial must sign the informed consent. Randomization 1:1 will be stratified by age (≤50 and \>50 years old) and clinical tumor size (≤2 cm and \>2 cm).

The sample size estimated is 364 women in each arm (400 to account for losses to follow-up). Sample size was calculated according to the following parameters: 90% disease-free survival in patients undergoing SLND and a minimum 85% in those not undergoing the procedure, 80% power and 95% confidence intervals, with a tolerated risk ratio of 0.8. After surgery, regardless of adjuvant therapies, and for at least 48 months, patients will undergo physical examination of their breasts and axilla every 6 months and mammography will be performed annually or at closer intervals if indicated. Adjuvant chemotherapy and radiotherapy will be performed according to the protocol of each participating center and patients without axillary surgery should be considered N0 for decision making.

Sentinel Lymph Node Biopsy Versus no Axillary Surgery in Early Breast Cancer

Sentinel Lymph Node Biopsy Versus no Axillary Surgery in Early Breast Cancer Clinically and Ultrasonographically Node-negative

Interval between the end of treatment and the diagnosis of any disease recurrence (breast, axilla or distant) by image exams or biopsy

Defined time period between the end of treatment and the patient's death from any cause.

Interval between the end of treatment and the diagnosis of any recorrence locoregional (breast or axilla) by biopsy

Percentage of patients with disease recurrence in axilla by biopsy in each grup

University of Campinas, Brazil

MD PhD

BCS only. Ommission of SLNB by axilla ultrasonography among selective breast cancer patients

No SLNB

Wonshik Han

NAUTILUS study is a prospective, multicenter, RCT. Clinically T1,T2, node negative BCS candidates with no evidence of metastases in AUS are 1:1 randomized into no SLNB group and SLNB group.

NAUTILUS study aim to establish the minimally invasive treatment of breast cancer by reexamining the necessity of sentinel lymph node biopsy among patients with invasive breast cancer who have tumors under 5cm, are clinically node-negative, and are having breast conserving surgery performed.

\[Background\] Skipping ALND, the follow-up treatment in SN-positive patients, has non-inferior oncological outcomes compared to SLNB-only group, given that there is no severe SN metastases.

Axillary ultrasound can effectively exclude high nodal burden, showing 95% NPV in a systematic review.

SLNB has morbidity including lymphedema, limited range of motion, pain, and other post-surgical complications, eventually leading to reduced quality of life.

Considering improvement of imaging modalities and adjuvant care, survival outcome of SLNB must be re-evaluated. Especially research reflective of the regional specificities of Korea and Asia-Pacific is needed.

\[Study design\] Prospective, Multicenter, RCT.

\[Statistical considerations\] According to Z0011 trial, 5yr DFS in eligible patients is expected to be 86%, which is between previous data of 88.6% in cT1,2 and SN-negative patients4, and 83.9% in cT1,2 and 1-2 SN-positive patients.

Non-inferiority margin is set at 5%. With 5% significance level and 80% power, 780 patients are needed in each group. Assuming a 10% drop out rate, 1734 patients need to be recruited.

\[Screening and Randomization\] Participants undergo screening tests that assess eligibility according to inclusion/exclusion criteria.

In order to identify axillary lymph node metastases, axillary ultrasound is first performed by radiologists. Patients showing normal features are enrolled, while for conditionally normal patients, with only 1 suspicion of low nodal burden, axillary lymph node biopsy should be performed. Suspicious patients are excluded under following conditions: patients with 1 or more suspicion of high nodal burden, 2 or more suspicion of low nodal burden, or T2 invasive lobular carcinoma patients with 1 or more low nodal burden. The severity of nodal burden is defined through the criteria.

Patients who underwent radiological axillary staging are randomly assigned (1:1) to the study arm and the control arm before surgical care. Stratification is done based on trial centers and tumor sizes.

\[Post-surgical care\] All patients are planned to receive ipsilateral whole breast radiation. Patients randomized to non-SLNB arm are recommended to follow high tangential radiotherapy protocol, in which upper margin of radiation field includes axillary level I and II or lies within 2CM from humeral head.

Additional treatment may be performed if deemed necessary by the researcher

\[Objectives\]

1. Primary objective

   - 5yr invasive Disease Free Survival
2. Secondary objectives

   * 5yr Overall Survival
   * 5yr Distant Metastasis Free Survival
   * Axillary recurrence rate
   * Patient reported AE
   * QoL

No Axillary sUrgical Treatment In Clinically Lymph Node Negative Patients After UltraSonography

No Axillary sUrgical Treatment In Clinically Lymph Node Negative Patients After UltraSonography[NAUTILUS]: A Prospective, Multicenter, Phase III Clinical Trial

Evaluate distant metastasis free survival

Evaluate ipsilateral axillary recurrence rate

Evaluate Quality of Life of patient by EORTC QLQ-C30 questionnaire

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Sentinel Lymph Node Biopsy Versus no Axillary Surgery in Early Breast Cancer	NCT05315154	Breast Cancer	No axillary sur... SLNB	18 Years -	University of Campinas, Brazil
No Axillary sUrgical Treatment In Clinically Lymph Node Negative Patients After UltraSonography	NCT04303715	Breast Cancer Sentinel Lymph ...	No SLNB SLNB	19 Years -	Seoul National University Hospital
No Axillary sUrgical Treatment In Clinically Lymph Node Negative Patients After UltraSonography	NCT04303715	Breast Cancer Sentinel Lymph ...	No SLNB SLNB	19 Years -	Seoul National University Hospital

Spots Global Cancer Trial Database for slnb

Every month we try and update this database with for slnb cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for slnb

Every month we try and update this database with for slnb cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for slnb cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.