Sentinel Lymph Node Biopsy Versus no Axillary Surgery in Early Breast Cancer
VENUS
2 other identifiers
interventional
800
1 country
18
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable breast-cancer
Started Oct 2019
Longer than P75 for not_applicable breast-cancer
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 2, 2019
CompletedFirst Submitted
Initial submission to the registry
March 20, 2022
CompletedFirst Posted
Study publicly available on registry
April 7, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 22, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
October 2, 2029
ExpectedMay 7, 2026
May 1, 2026
6.6 years
March 20, 2022
May 3, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Disease free survival (DFS)
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 Outcomes (3)
Overall survival (OS)
5 years
Locoregional free survival
5 years
Axillary recurrence rate
5 years
Study Arms (2)
No axillary surgery
EXPERIMENTALSentinel lymph node biopsy
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (18)
Hospital Geral de Fortaleza
Fortaleza, Ceará, Brazil
Maternidade Dona Iris
Goiânia, Goiás, Brazil
Universidade Federal de Goiás
Goiânia, Goiás, Brazil
Hospital de Clínica da Universidade Federal de Minas Gerais
Belo Horizonte, Minas Gerais, Brazil
Hospital do Câncer de Muriaé da Fundação Cristiano Varella
Muriaé, Minas Gerais, Brazil
Universidade Federal do Paraná
Curitiba, Paraná, Brazil
Hospital Barão de Lucena
Recife, Pernambuco, Brazil
Oncocenter
Teresina, Piauí, Brazil
Universidade Federal do Piauí
Teresina, Piauí, Brazil
Hospital Federal da Lagoa
Rio de Janeiro, Rio de Janeiro, Brazil
Liga Norte Riograndense Contra o Câncer
Natal, Rio Grande do Norte, Brazil
Hospital de Clínicas de Porto Alegre - UFRS
Porto Alegre, Rio Grande do Sul, Brazil
Hospital de Amor - Fundação Pio XII
Barretos, São Paulo, Brazil
Unesp
Botucatu, São Paulo, Brazil
Hospital Celso Pierro - PUCC
Campinas, São Paulo, Brazil
Hospital da Mulher Prof.Dr. J A Pinotti - UNICAMP
Campinas, São Paulo, Brazil
Hospital da Mulher
São Paulo, São Paulo, Brazil
Hospital do Servidor Público Estadual
São Paulo, São Paulo, Brazil
Related Publications (2)
Araujo DCM, Duarte GM, Jales RM, Shinzato JY, Cardoso Filho C, Torresan RZ, Brenelli FP, Esteves SCB, Sarian LO. Sentinel lymph node biopsy vs no axillary surgery in early breast cancer clinically and ultrasonographically node negative: A prospective randomized controlled trial-VENUS trial. Breast J. 2020 Oct;26(10):2087-2089. doi: 10.1111/tbj.13994. Epub 2020 Jul 30. No abstract available.
PMID: 32729181BACKGROUNDDuarte GM, Araújo DCM, Jales RM, Shinzato JY, Cardoso Filho C, Torresan RZ, Brenelli FB, Kraft MBPL, Esteves SCB, Sarian LOZ, Rahal RMS, Freitas Jr R, Pessoa EC, Lucena CEM, Damin APS, Biazus JV, Budel VM, Oliveira Jr I, Vieira RAC, Gomes JCN. Sentinel lymph node biopsy versus no axillary surgery in early breast cancer clinically and ultrasonographically node negative: A multicentre prospective randomized controlled trial (VENUS trial. Cancer Research. 2022 82 (4_Supplement): OT1-04-03. DOI: https://doi.org/10.1158/1538-7445.SABCS21-OT1-04-03 Published: 15 February 2022
BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Giuliano Duarte, MD, PhD
Universidade Estadual de Campinas, Unicamp
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD PhD
Study Record Dates
First Submitted
March 20, 2022
First Posted
April 7, 2022
Study Start
October 2, 2019
Primary Completion
April 22, 2026
Study Completion (Estimated)
October 2, 2029
Last Updated
May 7, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will not share