RecruitingNot ApplicableNCT05315154

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

Sponsor

University of Campinas, Brazil

Enrollment

800 participants

Start Date

Oct 2, 2019

Study Type

INTERVENTIONAL

Conditions

Breast Cancer

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: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study compares two approaches to armpit (axillary) surgery in women with early breast cancer: the standard sentinel lymph node biopsy versus no axillary surgery at all. The goal is to see if skipping the armpit surgery entirely is safe for women whose cancer appears not to have spread to the lymph nodes. **You may be eligible if...** - You are a woman aged 18 or older - You have confirmed invasive breast cancer (by biopsy) - Your tumor is smaller than 5 cm (T1 or T2 stage) - Your armpit lymph nodes appear cancer-free on physical exam and ultrasound (or biopsy if ultrasound looked suspicious) - You are planning breast-conserving surgery or mastectomy **You may NOT be eligible if...** - You have a history of any prior invasive cancer - Your lymph nodes are confirmed to contain cancer - You have distant metastases - You received chemotherapy before surgery (neoadjuvant chemotherapy) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

PROCEDURENo axillary surgery

In the study arm will be omitted surgery in axilla

PROCEDURESLNB

in the control arm will be realized SLNB

Locations(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

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05315154

Related Trials

Genomic Services Research Program

NCT025959571 location

A Synthetic Lethality-Focused Algorithm to Identify Therapeutic Options in Advanced Metastatic Breast Cancer (SYNTHESIS-Breast)

NCT070671381 location

Safety and Tolerability of ²¹²Pb-DOTAM-GRPR1 in Adult Subjects With Recurrent or Metastatic GRPR-expressing Tumors

NCT052833304 locations

A Phase III Study of Dato-DXd With or Without Durvalumab Compared With Investigator's Choice of Chemotherapy in Combination With Pembrolizumab in Patients With PD-L1 Positive Locally Recurrent Inoperable or Metastatic Triple-negative Breast Cancer

NCT06103864316 locations

Sodium-glucose Transporter Type 2 Inhibition in Anthracycline-related Cardiotoxicity

NCT070707652 locations