Clinical Trial Details
— Status: Active, not recruiting
Administrative data
NCT number |
NCT04303715 |
Other study ID # |
NAUTILUS study |
Secondary ID |
|
Status |
Active, not recruiting |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
September 15, 2020 |
Est. completion date |
December 31, 2027 |
Study information
Verified date |
November 2023 |
Source |
Seoul National University Hospital |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
NAUTILUS study is a prospective, multicenter, RCT. Clinically T1,T2, node negative BCS
candidates with no evidence of metastases in AUS are 1:1 randomized into no SLNB group and
SLNB group.
NAUTILUS study aim to establish the minimally invasive treatment of breast cancer by
reexamining the necessity of sentinel lymph node biopsy among patients with invasive breast
cancer who have tumors under 5cm, are clinically node-negative, and are having breast
conserving surgery performed.
Description:
[Background] Skipping ALND, the follow-up treatment in SN-positive patients, has non-inferior
oncological outcomes compared to SLNB-only group, given that there is no severe SN
metastases.
Axillary ultrasound can effectively exclude high nodal burden, showing 95% NPV in a
systematic review.
SLNB has morbidity including lymphedema, limited range of motion, pain, and other
post-surgical complications, eventually leading to reduced quality of life.
Considering improvement of imaging modalities and adjuvant care, survival outcome of SLNB
must be re-evaluated. Especially research reflective of the regional specificities of Korea
and Asia-Pacific is needed.
[Study design] Prospective, Multicenter, RCT.
[Statistical considerations] According to Z0011 trial, 5yr DFS in eligible patients is
expected to be 86%, which is between previous data of 88.6% in cT1,2 and SN-negative
patients4, and 83.9% in cT1,2 and 1-2 SN-positive patients.
Non-inferiority margin is set at 5%. With 5% significance level and 80% power, 780 patients
are needed in each group. Assuming a 10% drop out rate, 1734 patients need to be recruited.
[Screening and Randomization] Participants undergo screening tests that assess eligibility
according to inclusion/exclusion criteria.
In order to identify axillary lymph node metastases, axillary ultrasound is first performed
by radiologists. Patients showing normal features are enrolled, while for conditionally
normal patients, with only 1 suspicion of low nodal burden, axillary lymph node biopsy should
be performed. Suspicious patients are excluded under following conditions: patients with 1 or
more suspicion of high nodal burden, 2 or more suspicion of low nodal burden, or T2 invasive
lobular carcinoma patients with 1 or more low nodal burden. The severity of nodal burden is
defined through the criteria.
Patients who underwent radiological axillary staging are randomly assigned (1:1) to the study
arm and the control arm before surgical care. Stratification is done based on trial centers
and tumor sizes.
[Post-surgical care] All patients are planned to receive ipsilateral whole breast radiation.
Patients randomized to non-SLNB arm are recommended to follow high tangential radiotherapy
protocol, in which upper margin of radiation field includes axillary level I and II or lies
within 2CM from humeral head.
Additional treatment may be performed if deemed necessary by the researcher
[Objectives]
1. Primary objective
- 5yr invasive Disease Free Survival
2. Secondary objectives
- 5yr Overall Survival
- 5yr Distant Metastasis Free Survival
- Axillary recurrence rate
- Patient reported AE
- QoL