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.
調査の概要
状態
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Wonshik Han, Professor
- 電話番号：82-2-2072-0706
- メール：hanw@snu.ac.kr
研究場所
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-
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Seoul、韓国、03080
- Seoul National University Hospital
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コンタクト：
- Wonshik Han, Professor
- 電話番号：82-2-2072-0706
- メール：hanw@snu.ac.kr
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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 |
|
アクティブコンパレータ：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. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Invasive disease free survival
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Overall survival
時間枠：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
時間枠：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
|
|
Axillary recurrence
時間枠：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
|
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Health-related quality of life
時間枠：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
|
協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- NAUTILUS-04
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD 共有時間枠
Beginning 12 months after publication of the primary results, ending 3 years thereafter
IPD 共有アクセス基準
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 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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