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Clinical Trials in Brazil / NCT05315154
Active, not recruiting Not applicable

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

NCT05315154 · tracked via the Priya Life Science Brazil tracker
Sponsor
University of Campinas, Brazil
Phase
Not applicable
Started
2019-10-02
Last updated
2026-05-07

Condition(s) studied

Breast Cancer

Investigational drug(s) / intervention(s)

No axillary surgerySLNB

No axillary surgery: In the study arm will be omitted surgery in axilla

SLNB: in the control arm will be realized SLNB

Study 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.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (18)

FacilityCityRegionStatus
Hospital Geral de Fortaleza Fortaleza Ceará
Maternidade Dona Iris Goiânia Goiás
Universidade Federal de Goiás Goiânia Goiás
Hospital de Clínica da Universidade Federal de Minas Gerais Belo Horizonte Minas Gerais
Hospital do Câncer de Muriaé da Fundação Cristiano Varella Muriaé Minas Gerais
Universidade Federal do Paraná Curitiba Paraná
Hospital Barão de Lucena Recife Pernambuco
Oncocenter Teresina Piauí
Universidade Federal do Piauí Teresina Piauí
Hospital Federal da Lagoa Rio de Janeiro Rio de Janeiro
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 de Amor - Fundação Pio XII Barretos São Paulo
Unesp Botucatu São Paulo
Hospital Celso Pierro - PUCC Campinas São Paulo
Hospital da Mulher Prof.Dr. J A Pinotti - UNICAMP Campinas São Paulo
Hospital da Mulher São Paulo São Paulo
Hospital do Servidor Público Estadual São Paulo São Paulo

More University of Campinas, Brazil trials in Brazil

Assessment of Tooth Mobility After Non-surgical Periodontal Treatment Followed by Tooth Splinting Enrolling by invitation
MIST Versus M-MIST for the Treatment of Intrabony Defects Active, not recruiting
Evaluation of Implantoplasty in the Treatment of Peri-Implantitis. Active, not recruiting
Effects of Topical Insulin on Corneal Epithelium Healing After Corneal Crosslinking in Patients With Keratoconus Recruiting
Structural and Clinical Predictors of Cognitive Impairment After Surgical Treatment for Ruptured Cerebral Aneurysms Starting soon

Other trials for the same condition

Safety Extension Study for Subjects With HR+, HER2- Breast Cancer for Subjects Who Have Completed the OVELIA Study Enrolling by invitation
A Study of Dato-DXd Versus Investigator's Choice Chemotherapy in Patients With Locally Recurrent Inoperable or Metastatic Triple-negative Breast Cancer, Who Are Not Candidates for PD-1/PD-L1 Inhibitor Therapy (TROPION-Breast02) Active, not recruiting
A Study to Learn About the Study Medicine Called PF-07248144 in Combination With Fulvestrant in People With HR-positive, HER2-negative Advanced or Metastatic Breast Cancer Who Progressed After a Prior Line of Treatment. Recruiting
A Phase II Study Evaluating the Efficacy and Safety of Inavolisib Plus Ribociclib Plus Fulvestrant Versus Placebo Plus Ribociclib Plus Fulvestrant in Participants With Advanced Breast Cancer Recruiting
Hypofractionated Radiotherapy in Breast Cancer Patients With Prosthetic Reconstruction Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05315154 on ClinicalTrials.gov ↗ ← All trials in Brazil