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Conservative Surgery With or Without Axillary Lymphnode Removal in Treating Women With T1N0 Breast Cancer

NCT01508546 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 565

Last updated 2012-01-12

No results posted yet for this study

Summary

Rationale

Axillary surgery is still fundamental part of breast cancer (BC) management for adjuvant treatment planning.

Purpose

Randomized phase III trial to compare the effectiveness of surgical therapy with or without axillary dissection following conservative treatment in women with stage I breast cancer.

To determine the possibility to avoid axillary surgery in patients with early breast cancer, finding an alternative method to define the need of adjuvant treatment without compromising long-term disease control.

Conditions

  • Female Breast Neoplasms
  • Carcinoma, Ductal, Breast

Interventions

PROCEDURE

axillary dissection

Conservative breast surgery with or without axillary dissection

Sponsors & Collaborators

  • Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

    lead OTHER

Principal Investigators

  • Roberto Agresti, MD · Fondazione IRCCS Istituto Nazionale dei Tumori, Milan

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
1998-05-31
Primary Completion
2003-05-31
Completion
2003-05-31

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 NCT01508546 on ClinicalTrials.gov