Breast CancerVENUSNCT05315154
Sentinel Lymph Node Biopsy Versus no Axillary Surgery in Early Breast Cancer
A study testing No axillary surgery and SLNB in people with Breast Cancer, run by University of Campinas, Brazil at 18 sites in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- No axillary surgery and SLNB
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 800 participants
- Where
- 18 sitesBrazil
- Study dates
- 2 Oct 2019to 2 Oct 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- 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
Who cannot join
- 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
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
Brazil18 sites
Hospital de Amor - Fundação Pio XII
Barretos, São Paulo
Hospital de Clínica da Universidade Federal de Minas Gerais
Belo Horizonte, Minas Gerais
Unesp
Botucatu, São Paulo
Hospital Celso Pierro - PUCC
Campinas, São Paulo
Hospital da Mulher Prof.Dr. J A Pinotti - UNICAMP
Campinas, São Paulo
Universidade Federal do Paraná
Curitiba, Paraná
Hospital Geral de Fortaleza
Fortaleza, Ceará
Maternidade Dona Iris
Goiânia, Goiás
Universidade Federal de Goiás
Goiânia, Goiás
Hospital do Câncer de Muriaé da Fundação Cristiano Varella
Muriaé, Minas Gerais
Liga Norte Riograndense Contra o Câncer
Natal, Rio Grande do Norte
Hospital de Clínicas de Porto Alegre - UFRS
Porto Alegre, Rio Grande do Sul
Hospital Barão de Lucena
Recife, Pernambuco
Hospital Federal da Lagoa
Rio de Janeiro, Rio de Janeiro
Hospital da Mulher
São Paulo, São Paulo
Hospital do Servidor Público Estadual
São Paulo, São Paulo
Oncocenter
Teresina, Piauí
Universidade Federal do Piauí
Teresina, Piauí
About this study
Official title: 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.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- No axillary surgery, SLNB
- Keywords
- Breast cancer, Sentinel Lymph Node
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No axillary surgeryProcedure or surgery
In the study arm will be omitted surgery in axilla
SLNBProcedure or surgery
in the control arm will be realized SLNB
| Study group | Role | What they receive |
|---|---|---|
| No axillary surgery | Experimental | Not described Receives: Procedure: No axillary surgery |
| Sentinel lymph node biopsy | Active comparator | Not described Receives: Procedure: SLNB |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 5 years
Secondary outcomes (3)
Overall survival (OS)
Defined time period between the end of treatment and the patient's death from any cause.
Measured: 5 years
Locoregional free survival
Interval between the end of treatment and the diagnosis of any recorrence locoregional (breast or axilla) by biopsy
Measured: 5 years
Axillary recurrence rate
Percentage of patients with disease recurrence in axilla by biopsy in each grup
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2022
- Study start2 Oct 2019
- Primary completion22 Apr 2026
- Study completion2 Oct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Campinas, Brazil
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giuliano Mendes Duarte, University of Campinas, Brazil
- Investigators
- Giuliano Duarte, MD, PhD, Principal investigator, Universidade Estadual de Campinas, Unicamp
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05315154
- Sponsor's protocol ID
- 06805118.2.1001.5404
- Other IDs
- RBR-8g6jbf
- Acronym
- VENUS
- Status last verified
- May 2026
- First submitted
- 20 Mar 2022
- Last updated
- 7 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32729181Duarte 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
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sentinel Lymph Node Biopsy Versus no Axillary Surgery in Early Breast Cancer Clinically and Ultrasonographically Node-negative
- ClinicalTrials.gov ID
- NCT05315154
- Acronym / sponsor ID
- VENUS / 06805118.2.1001.5404
- Conditions
- Breast Cancer
- Keywords
- Breast cancer, Sentinel Lymph Node
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- University of Campinas, BrazilUniversity, hospital or other
- Study start
- 2 Oct 2019 (actual)
- Primary completion
- 22 Apr 2026 (actual)
- Study completion
- 2 Oct 2029 (estimated)
- First posted
- 7 Apr 2022 (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.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No axillary surgery | Experimental | Procedure: No axillary surgery |
| Sentinel lymph node biopsy | Active comparator | Procedure: SLNB |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (6 listed)
- 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
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 |
|---|---|---|
| No axillary surgeryIn the study arm will be omitted surgery in axilla | Procedure or surgery | No axillary surgery |
| SLNBin the control arm will be realized SLNB | Procedure or surgery | Sentinel lymph node biopsy |
Primary outcome
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
3 secondary outcomes
Overall survival (OS)
Time frame: 5 years
Locoregional free survival
Time frame: 5 years
Axillary recurrence rate
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2026.
- Background: PubMed 32729181Araujo 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.
- BackgroundDuarte 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
- Individual participant dataSharing planned: No
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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.
Giuliano Duarte, MD, PhD principal investigator
Universidade Estadual de Campinas, Unicamp
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing No axillary surgery and SLNB in people with Breast Cancer, run by University of Campinas, Brazil at 18 sites in Brazil.
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 8 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 7 May 2026. 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 Brazil. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease free survival (DFS) (time frame: 5 years). 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 NCT05315154, which also lists 2 linked publications.
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 7 May 2026.