Active — Not RecruitingNot Applicable

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

Brazil800 participantsStarted 2019-10-02

Plain-language 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.

Who can participate

Age range18 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Disease free survival (DFS)

Timeframe: 5 years

Trial details

NCT IDNCT05315154

SponsorUniversity of Campinas, Brazil

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-04-22

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