|

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

RECRUITINGN/ASponsored by University of Campinas, Brazil
Actively Recruiting
PhaseN/A
SponsorUniversity of Campinas, Brazil
Started2019-10-02
Est. completion2025-12-31
Eligibility
Age18 Years+
SexFEMALE
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT05315154

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

Age: 18 Years+Sex: FEMALEHealthy volunteers accepted
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

Conditions2

Breast CancerCancer

Browse More Trials

Cancer trialsBreast Cancer trials

Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

This site does not provide medical advice. Always consult your doctor before considering enrollment in a clinical trial. Learn more on our About page.