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Axillary Dissection Based on the Histological Result of the Sentinel Node, in Patients With Breast Carcinoma

NCT00970983 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 532

Last updated 2011-11-29

No results posted yet for this study

Summary

The purpose of this study is to evaluate the disease free and overall survival of patients with breast carcinomas of small size, i.e., not greater than 2.0 cm and with clinically non palpable axillary lymph nodes, undergoing either conservative surgery and axillary dissection, or a similar treatment for the primary tumor and rapid analysis of the sentinel lymph node, the result of which determines axillary node dissection or its avoidance is based.

Conditions

  • Breast Carcinoma

Interventions

PROCEDURE

quadrantectomy and axillary dissection

standard quadrantectomy and axillary dissection

PROCEDURE

quadrantectomy + sentinel node biopsy

standard quadrantectomy and selective axillary dissection only if sentinel node biopsy is positive

Sponsors & Collaborators

  • European Institute of Oncology

    lead OTHER

Principal Investigators

  • Umberto Veronesi, MD · European Institute of Oncology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
1998-03-31
Primary Completion
2009-09-30
Completion
2010-04-30

Countries

  • Italy

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 NCT00970983 on ClinicalTrials.gov