Sentinel lymph node biopsy versus no axillary surgery in early breast cancer

Conditions

Breast cancer

M. Leite Kraft, G. M. Duarte, D. M. Araújo, R. M. Jales, J. Y. Shinzato et al. (31 authors)

Clinical Cancer Research2026-02-17

Abstract P5-11-08: Primary analysis of radiotherapy data from prospective randomized controlled phase III VENUS trial: sentinel lymph node biopsy Versus No axillary surgery in early breast cancer clinically and UltraSonographically node negative

Danielle Bastos Araújo, Giuliano Mendes Duarte, Sérgio Carlos Barros Esteves, Rodrigo Menezes Jales, Maria Beatriz Kraft et al. (29 authors)

Clinical Cancer Research2025-06-13

10.1158/1557-3265.sabcs24-p5-11-08

First interim analysis of radiotherapy data after 4.5 years of sentinel lymph node biopsy versus no axillary surgery in early breast cancer clinically and ultrasonographically node-negative: a prospective randomized controlled trial – venus trial

Danielle Cristina Miyamoto Araújo, Giuliano Mendes Duarte, Sérgio Carlos Barros Esteves, Rodrigo Menezes Jales, Eduardo Carvalho Pessoa et al. (8 authors)

Mastology2024-01-01

10.29289/259453942024v34s1011

Is it possible to omit axillary surgery after neoadjuvant therapy for breast cancer? Preliminary outcomes in patients who underwent neoadjuvant treatment in the ongoing venus trial – a randomized controlled clinical trial

Maria Beatriz de Paula Leite Kraft, Giuliano Mendes Duarte, Danielle Cristina Miyamoto Araújo, Rodrigo Menezes Jales, Vinícius Milani Budel et al. (8 authors)

Mastology2024-01-01

10.29289/259453942024v34s1008

Sentinel lymph node biopsy versus no axillary surgery in early breast cancer clinically and ultrasonographically node-negative: A prospective randomized controlled trial – venus trial early results after 3.5 years of study inception

Danielle Cristina Miyamoto Araújo, Giuliano Mendes Duarte, Maria Beatriz de Paula Leite Kraft Enz Hubert, Rodrigo Menezes Jales, Luı́s Otávio Sarian et al. (8 authors)

Mastology2023-01-01

10.29289/259453942023v33s1008

Abstract OT1-04-03: 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)

Giuliano Mendes Duarte, Danielle Cristina Myiamoto Araújo, Rodrigo Menezes Jales, Júlia Yoriko Shinzato, Cássio Cardoso Filho et al. (20 authors)

Cancer Research2022-02-15

10.1158/1538-7445.sabcs21-ot1-04-03

Interventions

It will be performed sentinel lymph node biopsy in 400 patients (control arm) and no axillar surgery in 400 patients (study arm)

Procedure/surgery

E04.506

E01.370.350.850

Eligibility

Sex/Gender

Female

Age

18 Years to 100 Years

Inclusion criteria

Inclusion criteria: Women with invasive breast carcinoma; tumor smaller than 5 cm (T1 or T2); negative axilla in clinical exam and ultrasound (with or without core biopsy or fine needle biopsy); older than 18 years; no previous diagnostic of invasive neoplasia (excluded skin cancer no melanoma); written informed consent

Exclusion criteria

Exclusion criteria: Withdrawal from participating of the study; metastatic disease in biopsy or image before treatment; pregnancy; breastfeed

Design outcomes

Primary

Measure	Time frame
The primary endpoint of the study is to compare disease-free survival at 5 years between patients that will undergo sentinel lymph node biopsy (control arm) and no axillary surgery (study arm), considering that the survival of study arm will not be less than control arm	—

Secondary

Measure	Time frame
To compare overall survival at 5 years between two arms: sentinel lymph node biopsy and no surgery;To compare locoregional free survival at 5 years between two arms: sentinel lymph node biopsy and no surgery;To evaluate the axillary recurrence rate in 2 arms of trial;To describe surgical early complications (seroma, pain, hematoma) and late complications (lymph-edema and mobility dysfunction) in both groups: control arm and study arm;To evaluate costs to perform sentinel lymph node biopsy or no	—

Measure

Time frame

To compare overall survival at 5 years between two arms: sentinel lymph node biopsy and no surgery;To compare locoregional free survival at 5 years between two arms: sentinel lymph node biopsy and no surgery;To evaluate the axillary recurrence rate in 2 arms of trial;To describe surgical early complications (seroma, pain, hematoma) and late complications (lymph-edema and mobility dysfunction) in both groups: control arm and study arm;To evaluate costs to perform sentinel lymph node biopsy or no

—

Countries

Brazil

Contacts

Public ContactGiuliano Duarte

Hospital da Mulher Prof. Dr. Jose Aristodemo Pinotti - CAISM - UNICAMP

giulianomduarte@gmail.com+55 19 35219305

Outcome results

None listed