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.
연구 개요
상태
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Wonshik Han, Professor
- 전화번호: 82-2-2072-0706
- 이메일: hanw@snu.ac.kr
연구 장소
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Seoul, 대한민국, 03080
- Seoul National University Hospital
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연락하다:
- Wonshik Han, Professor
- 전화번호: 82-2-2072-0706
- 이메일: hanw@snu.ac.kr
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 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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활성 비교기: 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. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Invasive disease free survival
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Overall survival
기간: 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
기간: 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
기간: 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
기간: 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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공동 작업자 및 조사자
스폰서
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- NAUTILUS-04
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 공유 기간
Beginning 12 months after publication of the primary results, ending 3 years thereafter
IPD 공유 액세스 기준
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 공유 지원 정보 유형
- 연구_프로토콜
- 수액
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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