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

Breast Cancer Clinical Trial

— VENUS  

Official title:

Sentinel Lymph Node Biopsy Versus no Axillary Surgery in Early Breast Cancer Clinically and Ultrasonographically Node-negative

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05315154
• Other study ID #: 06805118.2.1001.5404
• Secondary ID: RBR-8g6jbf
• Status: Recruiting
• Phase: N/A
• Start date: October 2, 2019
• Est. completion date: October 2, 2030

Study information

• Verified date: May 2023
• Source: University of Campinas, Brazil
• Contact: Giuliano Duarte, MD, PhD
• Phone: +55 19 35219305
• Email: estudovenus[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 safely omitted in presence of positive sentinel lymph node in patients treated with breast conserving therapy.Therefore, the pertinence of SLND in the approach to women with early BC is being questioned, once it is not injury-free. The ACOSOG Z0011 trial examined the safety of omitting ALND in patients with early BC and up to 2 positive nodes at SLND, undergoing conservative surgery plus breast radiotherapy. The 10-year worth of data from this trial strongly suggested that omitting the procedure in these restrict, well-selected, subsets of patients maybe safe. Neoadjuvant chemotherapy (NAC) may be the starting treatment step for women with aggressive BC subtypes even in early stages.The SENTINA and ACOSOG Z1071 trials revealed that for women with three or more negative nodes in SLND, the procedure's accuracy and false-negative rate lie within acceptable boundaries. Our hypothesis is that for patients with early BC (regardless of neoadjuvant systemic therapy), with clinically and ultrasound negative axilla, avoiding SLND may be safe from the oncological perspective.The VENUS trial will investigate whether there may be still room for further de-escalation of the approach to the axilla in well-selected subsets of BC patients, by including women for whom the de-escalation has not been tested in previous trials dealing with the subject. The VENUS trial is a prospective, noninferiority, multicenter, randomized controlled clinical trial that was approved by the Local Research Ethic Committee .The trial will compare SLND with no axillary surgery in women with T1-2 invasive BC and N0 disease, as ascertained after clinical palpation and axillary ultrasound. Mastectomy and primary systemic therapy are allowed whether node negative previous start the treatment . All women accrued to the trial must sign the informed consent. Randomization 1:1 will be stratified by age (≤50 and >50 years old) and clinical tumor size (≤2 cm and >2 cm). The sample size estimated is 364 women in each arm (400 to account for losses to follow-up). Sample size was calculated according to the following parameters: 90% disease-free survival in patients undergoing SLND and a minimum 85% in those not undergoing the procedure, 80% power and 95% confidence intervals, with a tolerated risk ratio of 0.8. After surgery, regardless of adjuvant therapies, and for at least 48 months, patients will undergo physical examination of their breasts and axilla every 6 months and mammography will be performed annually or at closer intervals if indicated. Adjuvant chemotherapy and radiotherapy will be performed according to the protocol of each participating center and patients without axillary surgery should be considered N0 for decision making.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 800
• Est. completion date: October 2, 2030
• Est. primary completion date: October 2, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Procedure:
• No axillary surgery
In the study arm will be omitted surgery in axilla
• SLNB
in the control arm will be realized SLNB

Locations

Country	Name	City	State
Brazil	Hospital de Amor - Fundação Pio XII	Barretos	SP
Brazil	Hospital de Clínica da Universidade Federal de Minas Gerais	Belo Horizonte	MG
Brazil	Unesp	Botucatu	SP
Brazil	Hospital Celso Pierro - PUCC	Campinas	SP
Brazil	Hospital da Mulher Prof.Dr. J A Pinotti - UNICAMP	Campinas	SP
Brazil	Universidade Federal do Paraná	Curitiba	PR
Brazil	Hospital Geral de Fortaleza	Fortaleza	CE
Brazil	Maternidade Dona Iris	Goiânia	GO
Brazil	Universidade Federal de Goiás	Goiânia	GO
Brazil	Hospital do Câncer de Muriaé da Fundação Cristiano Varella	Muriaé	MG
Brazil	Liga Norte Riograndense Contra o Câncer	Natal	RN
Brazil	Hospital de Clínicas de Porto Alegre - UFRS	Porto Alegre	RS
Brazil	Hospital Barão de Lucena	Recife	PE
Brazil	Hospital Federal da Lagoa	Rio De Janeiro	RJ
Brazil	Hospital do Servidor Público Estadual	São Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
University of Campinas, Brazil

Country where clinical trial is conducted

Brazil, 

References & Publications (2)

Araujo DCM, Duarte GM, Jales RM, Shinzato JY, Cardoso Filho C, Torresan RZ, Brenelli FP, Esteves SCB, Sarian LO. Sentinel lymph node biopsy vs no axillary surgery in early breast cancer clinically and ultrasonographically node negative: A prospective randomized controlled trial-VENUS trial. Breast J. 2020 Oct;26(10):2087-2089. doi: 10.1111/tbj.13994. Epub 2020 Jul 30. No abstract available. — View Citation

Duarte GM, Araújo DCM, Jales RM, Shinzato JY, Cardoso Filho C, Torresan RZ, Brenelli FB, Kraft MBPL, Esteves SCB, Sarian LOZ, Rahal RMS, Freitas Jr R, Pessoa EC, Lucena CEM, Damin APS, Biazus JV, Budel VM, Oliveira Jr I, Vieira RAC, Gomes JCN. Sentinel lymph node biopsy versus no axillary surgery in early breast cancer clinically and ultrasonographically node negative: A multicentre prospective randomized controlled trial (VENUS trial. Cancer Research. 2022 82 (4_Supplement): OT1-04-03. DOI: https://doi.org/10.1158/1538-7445.SABCS21-OT1-04-03 Published: 15 February 2022

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease free survival (DFS)	Interval between the end of treatment and the diagnosis of any disease recurrence (breast, axilla or distant) by image exams or biopsy	5 years
Secondary	Overall survival (OS)	Defined time period between the end of treatment and the patient's death from any cause.	5 years
Secondary	Locoregional free survival	Interval between the end of treatment and the diagnosis of any recorrence locoregional (breast or axilla) by biopsy	5 years
Secondary	Axillary recurrence rate	Percentage of patients with disease recurrence in axilla by biopsy in each grup	5 years