NAUTILUS-04: No Axillary Surgical Treatment in Low-Risk Clinically Node-Negative Breast Cancer Without Whole-Breast Radiotherapy (NAUTILUS-04)
A Multicenter Randomized Controlled Non-Inferiority Trial of No Axillary Surgical Treatment in Low-Risk Clinically Node-Negative Breast Cancer Without Whole-Breast Radiotherapy
The safety of omitting sentinel lymph node biopsy (SLNB) has been established only in patients undergoing breast-conserving surgery with whole-breast radiotherapy, as demonstrated in the prior randomized trials. Whether SLNB can be omitted in patients who will not receive whole-breast radiotherapy remains unknown, despite the parallel expansion of radiotherapy de-escalation in low-risk populations.
NAUTILUS-04 is a prospective, multicenter, randomized, phase III non-inferiority trial evaluating the oncologic safety of SLNB omission in postmenopausal patients with low-risk, clinically node-negative breast cancer who are not planned to receive whole-breast radiotherapy.
Eligible patients are postmenopausal women aged 55 years or older with estrogen receptor-positive, HER2-negative invasive breast cancer, clinical T1-2 and clinically node-negative disease confirmed by physical examination and axillary ultrasound, without neoadjuvant systemic therapy. Patients must be planned for one of three local treatments: breast-conserving surgery without radiotherapy, breast-conserving surgery with accelerated partial breast irradiation, or mastectomy without radiotherapy.
A total of 1,520 patients will be randomized 1:1 to SLNB or no axillary surgery, stratified by planned breast surgery (breast-conserving surgery versus mastectomy) and age (55-64 versus 65 years or older). The primary endpoint is 5-year invasive disease-free survival. Secondary endpoints include 5-year axillary recurrence-free survival, distant recurrence-free survival, overall survival, and quality of life assessed by the EORTC QLQ questionnaire.
Visão geral do estudo
Status
Intervenção / Tratamento
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Wonshik Han, Professor
- Número de telefone: 82-2-2072-0706
- E-mail: hanw@snu.ac.kr
Locais de estudo
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Seoul, Coréia do Sul, 03080
- Seoul National University Hospital
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Contato:
- Wonshik Han, Professor
- Número de telefone: 82-2-2072-0706
- E-mail: hanw@snu.ac.kr
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- Postmenopausal women aged 55 years or older
- Histologically confirmed invasive breast cancer
- Estrogen receptor-positive and HER2-negative
- Clinical T1-2
- Clinically node-negative by physical examination and axillary ultrasound
- No neoadjuvant systemic therapy
- Not planned to receive whole-breast radiotherapy
- Planned for one of the following local treatments:
- Cohort 1: Breast-conserving surgery without radiotherapy
- Age under 65 years with clinical T1 tumor and biologically low risk, defined as Oncotype DX Recurrence Score 18 or less, OncoFREE Decision Index 15 or less, or Ki-67 13.25% or less with histologic grade 1 or 2
- Age 65 years or older with clinical tumor size 3 cm or less and histologic grade 1 or 2
- Cohort 2: Breast-conserving surgery with accelerated partial breast irradiation, with clinical T1 tumor and histologic grade 1 or 2
- Cohort 3: Mastectomy without radiotherapy, with histologic grade 1 or 2
- Written informed consent
Exclusion Criteria:
- Clinically or radiologically suspicious axillary lymph nodes
- Prior ipsilateral invasive breast cancer or prior axillary surgery
- Bilateral breast cancer
- Inflammatory breast cancer
- Pregnancy
- Any condition that precludes protocol-specified surgery or follow-up
- Concurrent participation in another interventional clinical trial that may affect the primary endpoint of this study
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: SLN omission group
No axillary surgery |
Planned breast surgery is performed without any axillary surgical procedure. Neither sentinel lymph node biopsy nor axillary lymph node dissection is performed. Adjuvant treatment decisions are made without pathologic nodal information |
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Comparador Ativo: SLN group
Sentinel lymph node biopsy |
Sentinel lymph node biopsy is performed at the time of planned breast surgery. Subsequent axillary management and adjuvant treatment decisions follow institutional standard practice based on the pathologic nodal findings. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Invasive disease free survival
Prazo: 5 years after randomization
|
Invasive disease-free survival is defined as the time from randomization to the first occurrence of invasive ipsilateral breast tumor recurrence, local or regional invasive recurrence, distant recurrence, contralateral invasive breast cancer, second primary invasive cancer, or death from any cause, according to the STEEP criteria. |
5 years after randomization
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Overall survival
Prazo: 5 years from randomization
|
Description: Overall survival is defined as the time from randomization to death from any cause. |
5 years from randomization
|
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Distant disease-free survival
Prazo: 5 years from randomization
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Distant disease-free survival is defined as the time from randomization to the first occurrence of distant recurrence or death from any cause, according to the STEEP criteria. |
5 years from randomization
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|
Axillary recurrence
Prazo: 5 years from randomization
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Axillary recurrence is defined as histologically or cytologically confirmed recurrence in the ipsilateral axillary lymph nodes, occurring as a first event or concurrently with other recurrence sites. |
5 years from randomization
|
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Health-related quality of life
Prazo: Before surgery, and 1 and 2 years after surgery
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Health-related quality of life assessed by the EORTC QLQ-C30 and EORTC QLQ-BR23 questionnaires. Scores are linearly transformed to a 0-100 scale. Higher scores on functional scales indicate better functioning, whereas higher scores on symptom scales indicate greater symptom burden. |
Before surgery, and 1 and 2 years after surgery
|
Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
- Neoplasias por local
- Neoplasias
- Doenças de pele
- Doenças da mama
- Doenças da Pele e do Tecido Conjuntivo
- Neoplasias da Mama
- Técnicas de investigação
- Manipulação de amostras
- Técnicas de laboratório clínico
- Técnicas e procedimentos de diagnóstico
- Diagnóstico
- Procedimentos cirúrgicos, operatórios
- Técnicas citológicas
- Biópsia
- Citodiagnóstico
- Técnicas de diagnóstico, cirúrgico
- Excisão de linfonodos
- Biópsia de linfonodo sentinela
Outros números de identificação do estudo
- NAUTILUS-04
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Prazo de Compartilhamento de IPD
Beginning 12 months after publication of the primary results, ending 3 years thereafter
Critérios de acesso de compartilhamento IPD
Requests should be directed to the principal investigator. Proposals will be reviewed by the study steering committee. Data will be shared after approval of the proposal and completion of a data access agreement.
Tipo de informação de suporte de compartilhamento de IPD
- PROTOCOLO DE ESTUDO
- SEIVA
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