Health TrialsbyHealthPanel

No Axillary Surgical Treatment in Clinically Lymph Node Negative Patients on Ultrasonography After Neoadjuvant Chemotherapy

ConditionsBreast CancerNeoadjuvant TherapySentinel Lymph Node Biopsy
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age19+
SponsorSeoul National University Hospital

About this trial

NEO-NAUTILUS is a prospective, multicenter, randomized phase III clinical trial to evaluate whether omitting axillary lymph node surgery (ALND or SLNB) in clinically lymph node-negative breast cancer patients after neoadjuvant chemotherapy is non-inferior to performing SLNB in terms of 5-year disease-free survival.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Women aged ≥19 years.

Histologically confirmed invasive breast carcinoma treated with neoadjuvant chemotherapy.

Clinical staging prior to NAC: cT1-3, cN0, M0 (AJCC 8th Edition).

HER2-positive or triple-negative breast cancer (TNBC).

Disqualifiers

History of any cancer within the past 5 years.

Bilateral breast cancer.

Patients requiring mastectomy.

Tumor size >5 cm after NAC.

Trial design

Design model

Parallel

Treatments tested in this trial

  • No axillary surgery

    Procedure/Surgery

    BCS only. Ommission of axillary surgery. No axillary surgery after neoadjuvant chemotherapy.

  • Axillary surgery

    Procedure/Surgery

    BCS with SLNB(+/-ALND)

Treatment groups

464 Participants
are divided into 2 treatment groups
Group A: No SLNB groupExperimental treatment 1 intervention
Group B: SLNB groupOther 1 intervention

Trial outcomes

Primary outcomes

1

Invasive Disease Free Survival (iDFS)

Evaluate invasive disease free survivals

Time frame
5 years

Secondary outcomes

1

Overall Survival (OS)

Evaluate overall survival

Time frame
5 years
2

Distant Metastasis Free Survival (DMFS)

Evaluate distant metastasis free survival

Time frame
5 years
3

Axillary recurrence rate

Evaluate ipsilateral axillary recurrence rate

Time frame
5 years
4

Locoregional Recurrence Rate (LRR)

Evaluate locoregional recurrence rate

Time frame
5 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Seoul National University Hospital

Lead sponsor

Asan Medical Center

Collaborator

Source ClinicalTrials.gov
Apply now