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. 2022 Feb 20;22(1):189.
doi: 10.1186/s12885-022-09273-1.

No axillary surgical treatment for lymph node-negative patients after ultra-sonography [NAUTILUS]: protocol of a prospective randomized clinical trial

Ji Gwang Jung  1 , Se Hyun Ahn  2 , Seeyoun Lee  3 , Eun-Kyu Kim  4 , Jai Min Ryu  5 , Seho Park  6 , Woosung Lim  7 , Yong Sik Jung  8 , Il Yong Chung  2 , Joon Jeong  9 , Ji Hyun Chang  10 , Kyung Hwan Shin  10 , Jung Min Chang  11 , Woo Kyung Moon  11 , Wonshik Han  12   13   14
Affiliations

No axillary surgical treatment for lymph node-negative patients after ultra-sonography [NAUTILUS]: protocol of a prospective randomized clinical trial

Ji Gwang Jung et al. BMC Cancer. .

Abstract

Background: Following sentinel lymph node biopsy (SLNB), the axillary recurrence rate is very low although SLNB has a false-negative rate of 5-10%. In the ACOSOG Z0011 trial, non-sentinel positive-lymph nodes were found in more than 20% of the axillary dissection group; the SLNB only group did not have a higher axillary recurrence rate. These findings raised questions about the direct therapeutic effect of the SLNB. SLNB has post-surgical complications including lymphedema. Considering advances in imaging modalities and adjuvant therapies, the role of SLNB in early breast cancer needs to be re-evaluated.

Methods: The NAUTILUS trial is a prospective multicenter randomized controlled trial involving clinical stage T1-2 and N0 breast cancer patients receiving breast-conserving surgery. Axillary ultrasound is mandatory before surgery with predefined imaging criteria for inclusion. Ultrasound-guided core needle biopsy or needle aspiration of a suspicious node is allowed. Patients will be randomized (1:1) into the no-SLNB (test) and SLNB (control) groups. A total of 1734 patients are needed, considering a 5% non-inferiority margin, 5% significance level, 80% statistical power, and 10% dropout rate. All patients in the two groups will receive ipsilateral whole-breast radiation according to a predefined protocol. The primary endpoint of this trial is the 5-year invasive disease-free survival. The secondary endpoints are overall survival, distant metastasis-free survival, axillary recurrence rate, and quality of life of the patients.

Discussion: This trial will provide important evidence on the oncological safety of the omission of SLNB for early breast cancer patients undergoing breast-conserving surgery and receiving whole-breast radiation, especially when the axillary lymph node is not suspicious during preoperative axillary ultrasound.

Trial registration: ClinicalTrials.gov, NCT04303715 . Registered on March 11, 2020.

Keywords: Breast cancer; Sentinel node biopsy; Ultrasound.

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Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
NAUTILUS trial: Study design
Fig. 2
Fig. 2
Diagram for the study process
See this image and copyright information in PMC

References

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