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Sentinel Node Vs Observation After Axillary Ultra-souND

NCT02167490 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1560

Last updated 2024-11-25

No results posted yet for this study

Summary

The hypothesis of this trial are that:

* avoiding axillary surgery does not worsen the outcome of patients with small breast cancer the absence of the pathological information on the risk of recurrence given by nodal status is not worsening outcome of these patients
* pre-operative imaging of the axilla can identify patients with clinically relevant nodal burden.

The aims of this prospective randomized study are:

* to verify whether, in presence of a negative preoperative axillary assessment, SLN can be spared
* to verify whether, in presence of a negative preoperative axillary assessment, the decision on adjuvant medical treatment can be taken according only to the biology of the tumour without the prognostic information achieved by SLNB on the nodal status
* to verify whether, in presence of a negative preoperative axillary assessment, the patients' quality of life can be improved by a less invasive surgical procedure.

Conditions

  • Early Stage Breast Carcinoma

Interventions

PROCEDURE

Arm 1: sentinel node biopsy

Sentinel node biopsy policy

Sponsors & Collaborators

  • European Institute of Oncology

    lead OTHER

Principal Investigators

  • Oreste D Gentilini, MD · European Institute of Oncology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2025-06-30
Completion
2025-06-30

Countries

  • Chile
  • Italy
  • Spain
  • Switzerland

Study Locations

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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 NCT02167490 on ClinicalTrials.gov