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T1-T2 Breast Cancer: Comparison Between Removal and Preservation of Axillary Lymph Nodes (SINODAR ONE)

NCT05160324 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 889

Last updated 2022-01-05

No results posted yet for this study

Summary

Italian Multicentric non inferiority two-arm randomized clinical trial to verify that the experimental treatment (omission of axillary lymph node intervention) in the presence of sentinel lymph node metastases does not lead to a significant worsening in survival or in the risk of locoregional recurrence compared to standard treatment (removal of I-II level of axillary lymph nodes).

Conditions

Interventions

PROCEDURE

Removal of axillary lymph nodes.

Axillary dissection in patients with positive sentinel lymph node

PROCEDURE

Preservation of axillary lymph nodes

Preservation of axillary lymph nodes in patients with positive sentinel lymph node

Sponsors & Collaborators

  • Fondazione Humanitas per la Ricerca

    lead OTHER

Principal Investigators

  • Corrado Tinterri, MD · Istituto Clinico Humanitas

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-04-14
Primary Completion
2025-04-30
Completion
2025-04-30

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Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05160324 on ClinicalTrials.gov