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Clinical Trials in Italy / NCT02167490
Active, not recruiting Not applicable

Sentinel Node Vs Observation After Axillary Ultra-souND

NCT02167490 · tracked via the Priya Life Science Italy tracker
Sponsor
European Institute of Oncology
Phase
Not applicable
Started
2012-01
Last updated
2024-11-25

Condition(s) studied

Early Stage Breast Carcinoma

Investigational drug(s) / intervention(s)

Arm 1: sentinel node biopsy

Arm 1: sentinel node biopsy: Sentinel node biopsy policy

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.

Eligibility

Sex
FEMALE
Min age
—
Max age
—
Healthy volunteers
No
Inclusion Criteria: * breast cancer \<2 cm, and a clinically negative axilla * any age * candidates to receive breast conserving surgery + radiotherapy * negative preoperative assessment of the axilla (ultra-sound with or without FNAC in case one doubtful node is found) * written informed consent must be signed and dated by the patient and the investigator prior to inclusion. * patients must be accessible for follow-up. Exclusion Criteria: * synchronous distant metastases * previous malignancy * bilateral breast cancer * multicentric or multifocal breast cancer * previous primary systemic therapy * pregnancy or breastfeeding * pre-operative diagnosis (cytology or histology) of axillary lymph node metastases * pre-operative radiological evidence of multiple involved or suspicious nodes * patients with psychiatric, addictive, or any disorder, which compromises ability to give informed consent for participation in this study.

Primary outcome measure(s)

  • Distant-disease free survival — 6 months

Trial sites (18)

FacilityCityRegionStatus
Instituto Oncologico Fundacion Arturo Lopez Perez Santiago Chile
Comprensorio Sanitario Bolzano Italy
Azienda Ospedaliera Spedali Civili Brescia Italy
Ospedale Oncologico Regionale Cagliari Italy
Humanitas Mater Domini Castellanza Italy
Ospedale S. Anna Como Italy
Azienda Ospedaliera Carlo Poma Mantua Italy
European Institute of Oncology Milan Italy
Fondazione IRCCS Istituto Nazionale Tumori Milan Italy
AOU Federico II Naples Italy
Istituto Nazionale Tumori Naples Italy
Ospedale San Matteo Pavia Italy
Ospedale Guglielmo di Saliceto Piacenza Italy
Ospedale Fatebenefratelli Roma Italy
Humanitas Cancer Center Rozzano Italy
Ospedale S. Anna Torino Italy
Health Research Institute Hospital La Fe Valencia Spain
Universitätsspital Bern Klinik und Poliklinik für Medizinische Onkologie Bern Switzerland

More European Institute of Oncology trials in Italy

MONDRIAN: Multi-omics Integrative Modelling for Stereotactic Body Radiotherapy in Early-stage Non-small Cell Lung Cancer Recruiting
YOUNg Adults With Gastro-inteSTinal (GI) and nEuroendocrine canceRs. Recruiting
A New Tool to Promote Patient's Engagement in Their Healthcare Process Recruiting
Cognitive Impairment Assessment in Breast Cancer Survivors Starting soon
Molecular Phenotyping of Primitive Lung Cancer and Metastatic Site Recruiting

Other trials for the same condition

EXamining PErsonalised Radiation Therapy for Low-risk Early Breast Cancer Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT02167490 on ClinicalTrials.gov ↗ ← All trials in Italy