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NAUTILUS-04: No Axillary Surgical Treatment in Low-Risk Clinically Node-Negative Breast Cancer Without Whole-Breast Radiotherapy (NAUTILUS-04)

4. oktober 2026 oppdatert av: Wonshik Han

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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

1520

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

  • Navn: Wonshik Han, Professor
  • Telefonnummer: 82-2-2072-0706
  • E-post: hanw@snu.ac.kr

Studiesteder

  • Sør -Korea
      • Seoul, Sør -Korea, 03080
        • Seoul National University Hospital
        • Ta kontakt med:
          • Wonshik Han, Professor
          • Telefonnummer: 82-2-2072-0706
          • E-post: hanw@snu.ac.kr

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

55 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Hunn

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: SLN omission group

No axillary surgery
Fremgangsmåte: Omission of 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
Aktiv komparator: SLN group

Sentinel lymph node biopsy
Fremgangsmåte: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Invasive disease free survival
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Overall survival
Tidsramme: 5 years from randomization

Description: Overall survival is defined as the time from randomization to death from any cause.
5 years from randomization
Distant disease-free survival
Tidsramme: 5 years from randomization

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
Axillary recurrence
Tidsramme: 5 years from randomization

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
Health-related quality of life
Tidsramme: Before surgery, and 1 and 2 years after surgery

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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Wonshik Han

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. oktober 2026

Primær fullføring (Antatt)

1. oktober 2034

Studiet fullført (Antatt)

1. oktober 2034

Datoer for studieregistrering

Først innsendt

19. september 2026

Først innsendt som oppfylte QC-kriteriene

19. september 2026

Først lagt ut (Faktiske)

25. september 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

8. oktober 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

4. oktober 2026

Sist bekreftet

1. september 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • NAUTILUS-04

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-delingstidsramme

Beginning 12 months after publication of the primary results, ending 3 years thereafter

Tilgangskriterier for IPD-deling

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.

IPD-deling Støtteinformasjonstype

  • STUDY_PROTOCOL
  • SEVJE

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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