Comparing sentinel lymph node biopsy to no surgery in early breast cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The VENUS trial is a multicenter, randomized clinical trial that evaluates the safety of omitting sentinel lymph node biopsy (SLNB) in women with early breast cancer who have clinically and sonographically negative axilla. The study aims to determine if avoiding SLNB is a safe option for well-selected patients, potentially reducing unnecessary surgical interventions. Participants include women aged 18 and older with invasive breast carcinoma and tumors smaller than 5 cm. The trial will compare outcomes between those undergoing SLNB and those who do not have any axillary surgery.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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 Criteria:

* 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

Where it's running

• Hospital Geral de Fortaleza
  Fortaleza, Ce, Brazil Recruiting
• Maternidade Dona Iris
  Goiânia, Go, Brazil Recruiting
• Universidade Federal de Goiás
  Goiânia, Go, Brazil Recruiting
• Hospital de Clínica da Universidade Federal de Minas Gerais
  Belo Horizonte, Mg, Brazil Recruiting
• Hospital do Câncer de Muriaé da Fundação Cristiano Varella
  Muriaé, Mg, Brazil Recruiting
• Hospital Barão de Lucena
  Recife, Pe, Brazil Recruiting

Study contacts

• Principal investigator: Giuliano Duarte, MD, PhD — Universidade Estadual de Campinas, Unicamp
• Study coordinator: Giuliano Duarte, MD, PhD
• Email: estudovenus@gmail.com
• Phone: +55 19 35219305

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.