Sentinel Lymph Node Biopsy Versus No Axillary Surgery in Early Breast Cancer
NCT ID: NCT05315154
Last Updated: 2024-12-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
800 participants
INTERVENTIONAL
2019-10-02
2030-10-02
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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No axillary surgery
No axillary surgery
In the study arm will be omitted surgery in axilla
Sentinel lymph node biopsy
SLNB
in the control arm will be realized SLNB
Interventions
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No axillary surgery
In the study arm will be omitted surgery in axilla
SLNB
in the control arm will be realized SLNB
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
FEMALE
No
Sponsors
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University of Campinas, Brazil
OTHER
Responsible Party
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Giuliano Mendes Duarte
MD PhD
Principal Investigators
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Giuliano Duarte, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Universidade Estadual de Campinas, Unicamp
Locations
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Hospital Geral de Fortaleza
Fortaleza, Ceará, Brazil
Maternidade Dona Iris
Goiânia, Goiás, Brazil
Universidade Federal de Goiás
Goiânia, Goiás, Brazil
Hospital de Clínica da Universidade Federal de Minas Gerais
Belo Horizonte, Minas Gerais, Brazil
Hospital do Câncer de Muriaé da Fundação Cristiano Varella
Muriaé, Minas Gerais, Brazil
Universidade Federal do Paraná
Curitiba, Paraná, Brazil
Hospital Barão de Lucena
Recife, Pernambuco, Brazil
Oncocenter
Teresina, Piauí, Brazil
Universidade Federal do Piauí
Teresina, Piauí, Brazil
Hospital Federal da Lagoa
Rio de Janeiro, Rio de Janeiro, Brazil
Liga Norte Riograndense Contra o Câncer
Natal, Rio Grande do Norte, Brazil
Hospital de Clínicas de Porto Alegre - UFRS
Porto Alegre, Rio Grande do Sul, Brazil
Hospital de Amor - Fundação Pio XII
Barretos, São Paulo, Brazil
Unesp
Botucatu, São Paulo, Brazil
Hospital Celso Pierro - PUCC
Campinas, São Paulo, Brazil
Hospital da Mulher Prof.Dr. J A Pinotti - UNICAMP
Campinas, São Paulo, Brazil
Hospital da Mulher
São Paulo, São Paulo, Brazil
Hospital do Servidor Público Estadual
São Paulo, São Paulo, Brazil
Countries
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Central Contacts
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Danielle Cristina Myamoto de Araujo, MD
Role: CONTACT
Facility Contacts
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Francisco Pimentel Cavalcante
Role: primary
Leonardo R Soares, MD PhD
Role: primary
Rosemar Rahal, MD, PhD
Role: primary
Clécio Enio M de Lucena, MD PhD
Role: primary
René Aloisio C Vieira, MD PhD
Role: primary
Vinícius Budel, MD PhD
Role: primary
Darley de Lima Ferreira Filho, MD
Role: primary
Sabas Vieira, MD, PhD
Role: primary
Sabas Vieira, MD, PhD
Role: backup
Kamila Diocesano, MD
Role: primary
Kamila Diocesano, MD
Role: backup
Rafael Henrique S Machado, MD PhD
Role: primary
Roberta D Jales Alves de Andrade, MD
Role: primary
Andréa PS Damin, MD PhD
Role: primary
Idan Oliveira, MD PhD
Role: primary
Eduardo Pessoa, MD, PhD
Role: primary
Julio César N Gomes
Role: primary
Giuliano M Duarte, MD, PhD
Role: primary
André Mattar, MD, PhD
Role: primary
André Mattar, MD, PhD
Role: backup
Marcelo Antonini
Role: primary
References
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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.
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
Other Identifiers
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RBR-8g6jbf
Identifier Type: REGISTRY
Identifier Source: secondary_id
06805118.2.1001.5404
Identifier Type: -
Identifier Source: org_study_id