Comparing sentinel lymph node biopsy to no surgery in early breast cancer
Sentinel Lymph Node Biopsy Versus No Axillary Surgery in Early Breast Cancer Clinically and Ultrasonographically Node-negative
This study is testing if women with early breast cancer can safely skip a specific type of surgery called sentinel lymph node biopsy, to see if it helps avoid unnecessary procedures.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 800 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | University of Campinas, Brazil Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 18 sites (Fortaleza, CE and 17 other locations) |
| Trial ID | NCT05315154 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 and older with histologically confirmed invasive breast carcinoma, tumors smaller than 5 cm, and clinically negative axilla.
Not a fit: Patients with previous invasive neoplasia, metastatic disease, or those who have started treatment for breast cancer prior to enrollment may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to less invasive treatment options for women with early breast cancer, reducing surgical risks and improving quality of life.
How similar studies have performed: Previous studies, such as ACOSOG Z0011, have shown that omitting axillary surgery can be safe in certain patient populations, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Fortaleza, CE and 17 other locations
- 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)
- Oncocenter — Teresina, Pi, Brazil (Recruiting)
- Universidade Federal do Piauí — Teresina, Pi, Brazil (Recruiting)
- Universidade Federal do Paraná — Curitiba, Pr, Brazil (Recruiting)
- Hospital Federal da Lagoa — Rio De Janeiro, Rj, Brazil (Recruiting)
- Liga Norte Riograndense Contra o Câncer — Natal, Rn, Brazil (Recruiting)
- Hospital de Clínicas de Porto Alegre - UFRS — Porto Alegre, Rs, Brazil (Recruiting)
- Hospital de Amor - Fundação Pio XII — Barretos, Sp, Brazil (Recruiting)
- Unesp — Botucatu, Sp, Brazil (Recruiting)
- Hospital Celso Pierro - PUCC — Campinas, Sp, Brazil (Recruiting)
- Hospital da Mulher Prof.Dr. J A Pinotti - UNICAMP — Campinas, Sp, Brazil (Recruiting)
- Hospital da Mulher — São Paulo, Sp, Brazil (Recruiting)
- Hospital do Servidor Público Estadual — São Paulo, Sp, Brazil (Not_yet_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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.