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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

Inclusion Criteria8

  • 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 Criteria6

  • 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

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

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NCT05315154

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