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.
Descripción general del estudio
Estado
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Wonshik Han, Professor
- Número de teléfono: 82-2-2072-0706
- Correo electrónico: hanw@snu.ac.kr
Ubicaciones de estudio
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Seoul, Corea del Sur, 03080
- Seoul National University Hospital
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Contacto:
- Wonshik Han, Professor
- Número de teléfono: 82-2-2072-0706
- Correo electrónico: hanw@snu.ac.kr
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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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 activo: 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. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Invasive disease free survival
Periodo de tiempo: 5 years after randomization
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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
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Overall survival
Periodo de tiempo: 5 years from randomization
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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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Neoplasias por sitio
- Neoplasias
- Enfermedades de la piel
- Enfermedades de los senos
- Enfermedades de la piel y del tejido conectivo
- Neoplasias de mama
- Técnicas de investigación
- Manejo de muestras
- Técnicas de laboratorio clínico
- Técnicas y procedimientos de diagnóstico
- Diagnóstico
- Procedimientos quirúrgicos, operativo
- Técnicas citológicas
- Biopsia
- Citodiagnóstico
- Técnicas de diagnóstico, quirúrgico
- Escisión de ganglios linfáticos
- Biopsia de ganglios linfáticos centinela
Otros números de identificación del estudio
- NAUTILUS-04
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Marco de tiempo para compartir IPD
Beginning 12 months after publication of the primary results, ending 3 years thereafter
Criterios de acceso compartido de 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 información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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