Status:
RECRUITING
Sentinel Lymph Node Biopsy Versus No Axillary Surgery in Early Breast Cancer
Lead Sponsor:
University of Campinas, Brazil
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief 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 canc...
Detailed Description
The standard approach to women with early breast cancer (BC) and clinically negative nodes is sentinel lymph node dissection (SLND). Studies showed that axillary lymph node dissection (ALND) can be sa...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 2 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 2 2030
Estimated Enrollment :
800 Patients enrolled
Trial Details
Trial ID
NCT05315154
Start Date
October 2 2019
End Date
October 2 2030
Last Update
December 12 2024
Active Locations (18)
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1
Hospital Geral de Fortaleza
Fortaleza, Ceará, Brazil
2
Maternidade Dona Iris
Goiânia, Goiás, Brazil
3
Universidade Federal de Goiás
Goiânia, Goiás, Brazil
4
Hospital de Clínica da Universidade Federal de Minas Gerais
Belo Horizonte, Minas Gerais, Brazil