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

May 3, 2026 updated by: Giuliano Mendes Duarte, University of Campinas, Brazil

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

800

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Ceará
      • Fortaleza, Ceará, Brazil
        • Hospital Geral de Fortaleza
    • Goiás
      • Goiânia, Goiás, Brazil
        • Maternidade Dona Iris
      • Goiânia, Goiás, Brazil
        • Universidade Federal de Goias
    • Minas Gerais
      • Belo Horizonte, Minas Gerais, Brazil
        • Hospital de Clínica da Universidade Federal de Minas Gerais
      • Muriaé, Minas Gerais, Brazil
        • Hospital do Câncer de Muriaé da Fundação Cristiano Varella
    • Paraná
      • Curitiba, Paraná, Brazil
        • Universidade Federal do Paraná
    • Pernambuco
      • Recife, Pernambuco, Brazil
        • Hospital Barão de Lucena
    • Piauí
      • Teresina, Piauí, Brazil
        • Oncocenter
      • Teresina, Piauí, Brazil
        • Universidade Federal do Piauí
    • Rio Grande do Norte
      • Natal, Rio Grande do Norte, Brazil
        • Liga Norte Riograndense Contra O Cancer
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brazil
        • Hospital de Clínicas de Porto Alegre - UFRS
    • Rio de Janeiro
      • Rio de Janeiro, Rio de Janeiro, Brazil
        • Hospital Federal da Lagoa
    • São Paulo
      • Barretos, São Paulo, Brazil
        • Hospital de Amor - Fundação Pio XII
      • Botucatu, São Paulo, Brazil
        • Unesp
      • Campinas, São Paulo, Brazil
        • Hospital Celso Pierro - PUCC
      • Campinas, São Paulo, Brazil
        • Hospital da Mulher Prof.Dr. J A Pinotti - UNICAMP
      • São Paulo, São Paulo, Brazil
        • Hospital da Mulher
      • São Paulo, São Paulo, Brazil
        • Hospital do Servidor Público Estadual

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Women
  • Aged 18 years or older
  • Histologically confirmed invasive breast carcinoma (core or open biopsy), independent of hormone receptor and HER2 status
  • Tumor smaller than 5 cm (T1 or T2) in clinical and radiological exams
  • Clinically negative axilla
  • Sonographically negative axilla or negative core biopsy/ fine needle biopsy (FNB) when ultrasound is suspect (lymph node tissue is required in core/FNB sample)
  • Planned breast conservative surgery or mastectomy
  • Written informed consent

Exclusion Criteria:

  • Previous diagnostic of any invasive neoplasia (excluded skin cancer no melanoma)
  • Metastatic disease in biopsy or image before treatment
  • Withdrawal from participating of the study
  • Initiated treatment for current breast cancer prior to study enrollment
  • Pregnancy
  • Breastfeed

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: No axillary surgery
Procedure: No axillary surgery
In the study arm will be omitted surgery in axilla
Active Comparator: Sentinel lymph node biopsy
Procedure: SLNB
in the control arm will be realized SLNB

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease free survival (DFS)
Time Frame: 5 years
Interval between the end of treatment and the diagnosis of any disease recurrence (breast, axilla or distant) by image exams or biopsy
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival (OS)
Time Frame: 5 years
Defined time period between the end of treatment and the patient's death from any cause.
5 years
Locoregional free survival
Time Frame: 5 years
Interval between the end of treatment and the diagnosis of any recorrence locoregional (breast or axilla) by biopsy
5 years
Axillary recurrence rate
Time Frame: 5 years
Percentage of patients with disease recurrence in axilla by biopsy in each grup
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Campinas, Brazil

Investigators

  • Principal Investigator: Giuliano Duarte, MD, PhD, Universidade Estadual de Campinas, Unicamp

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 2, 2019

Primary Completion (Actual)

April 22, 2026

Study Completion (Estimated)

October 2, 2029

Study Registration Dates

First Submitted

March 20, 2022

First Submitted That Met QC Criteria

April 6, 2022

First Posted (Actual)

April 7, 2022

Study Record Updates

Last Update Posted (Actual)

May 7, 2026

Last Update Submitted That Met QC Criteria

May 3, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 06805118.2.1001.5404
  • RBR-8g6jbf (Registry Identifier: ReBEC)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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