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

NCT05315154 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 800

Last updated 2026-05-07

No results posted yet for this 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.

Conditions

Interventions

PROCEDURE

No axillary surgery

In the study arm will be omitted surgery in axilla

PROCEDURE

SLNB

in the control arm will be realized SLNB

Sponsors & Collaborators

  • University of Campinas, Brazil

    lead OTHER

Principal Investigators

  • Giuliano Duarte, MD, PhD · Universidade Estadual de Campinas, Unicamp

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-02
Primary Completion
2026-04-22
Completion
2029-10-02

Countries

  • Brazil

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05315154 on ClinicalTrials.gov