Surgical Resection With or Without Axillary Lymph Node Dissection in Treating Women With Node-Negative Breast Cancer and Sentinel Lymph Node Micrometastases (23-01)

December 22, 2017 updated by: ETOP IBCSG Partners Foundation

A Randomized Trial Of Axillary Dissection Versus No Axillary Dissection For Patients With Clinically Node Negative Breast Cancer And Micrometastases In The Sentinel Node

RATIONALE: Surgery to remove lymph nodes in the armpit in patients with sentinel lymph node micrometastases may remove cancer cells that have spread from tumors in the breast. It is not yet known whether surgery to remove the primary tumor is more effective with or without axillary lymph node dissection.

PURPOSE: This randomized phase III trial is studying surgery and axillary lymph node dissection to see how well they work compared to surgery alone in treating women with node-negative breast cancer and sentinel lymph node micrometastases.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

  • Compare disease-free survival of women with clinically node-negative breast cancer with sentinel lymph node micrometastases treated with surgical resection with or without axillary dissection.
  • Compare overall survival of patients treated with these regimens.
  • Assess sites of recurrence, particularly reappearance of disease in the undissected axilla.
  • Assess long-term surgical complications in patients treated with these regimens.

OUTLINE: This is a multicenter study. Patients are stratified according to participating center, menopausal status (pre- vs postmenopausal), and preoperative sentinel node biopsy (yes vs no). Patients are followed every 4 months for 1 year, every 6 months for 4 years, and then annually thereafter.

Study Type

Interventional

Enrollment (Actual)

931

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Lismore, New South Wales, Australia, 2480
        • Lismore Base Hospital
      • Lismore, New South Wales, Australia, 2480
        • St Vincents Hospital
      • North Sydney, New South Wales, Australia, 2060
        • Mater Hospital - North Sydney
      • St. Leonards, New South Wales, Australia, 2065
        • Royal North Shore Hospital
      • Sydney, New South Wales, Australia, 2050
        • Sydney Cancer Centre at Royal Prince Alfred Hospital
      • Wagga Wagga, New South Wales, Australia, 2650
        • Riverina Cancer Care Centre
      • Westmead, New South Wales, Australia, 2145
        • Westmead Institute for Cancer Research at Westmead Hospital
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Royal Adelaide Hospital Cancer Centre
    • Victoria
      • Parkville, Victoria, Australia, 3050
        • Royal Melbourne Hospital
    • Western Australia
      • Bunbury, Western Australia, Australia, 6230
        • St. John of God Hospital - Bunbury
  • Belgium
      • Liege, Belgium, B-4000
        • CHU Liege - Domaine Universitaire du Sart Tilman
  • Brazil
    • Rio Grande Do Sul
      • Porto Alegre, Rio Grande Do Sul, Brazil, 90035-003
        • Hospital de Clinicas de Porto Alegre
  • Denmark
      • Horsholm, Denmark, 2970
        • Horsholm Sygenus
  • France
      • Villejuif, France, F-94805
        • Institut Gustave Roussy
  • Italy
      • Aviano, Italy, 33081
        • Centro di Riferimento Oncologico - Aviano
      • Bergamo, Italy, 24100
        • Ospedali Riuniti di Bergamo
      • Bologna, Italy, 40138
        • University of Bologna Medical School
      • Ferrara, Italy, 44100
        • Università di Ferrara
      • Lecco, Italy, 23900
        • Ospedale Alessandro Manzoni
      • Milan, Italy, 20132
        • Istituto Scientifico H. San Raffaele
      • Milan, Italy, 20141
        • European Institute of Oncology
      • Pavia, Italy, I-27100
        • Fondazione Salvatore Maugeri
  • New Zealand
      • Auckland, New Zealand
        • North Shore Hospital
      • Hamilton, New Zealand, 2020
        • Waikato Hospital
  • Peru
      • Lima, Peru, 34
        • Instituto Nacional de Enfermedades Neoplasicas
  • Slovenia
      • Ljubljana, Slovenia, Sl-1000
        • Institute of Oncology - Ljubljana
  • Switzerland
      • Aarau, Switzerland, CH-5001
        • Kantonspital Aarau
      • Bellinzona, Switzerland, CH-6500
        • Oncology Institute of Southern Switzerland
      • Bern, Switzerland, CH-3010
        • Inselspital Bern
      • Lausanne, Switzerland, CH-1011
        • Centre Hospitalier Universitaire Vaudois
      • St. Gallen, Switzerland, CH-9007
        • Kantonsspital - St. Gallen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

DISEASE CHARACTERISTICS:

  • Clinical, mammographic, ultrasonographic, or pathologic diagnosis of unicentric and unifocal breast carcinoma
  • Largest tumor lesion ≤ 5 cm

  • Palpable or nonpalpable breast lesion

    • Preoperative radioactive occult lesion localization, hook wire, or other method of localization required for nonpalpable lesions

  • Prior (preoperative) or planned (intraoperative) sentinel node biopsy required

    • At least 1 micrometastatic (i.e., no greater than 2 mm) sentinel lymph node with no extracapsular extension

  • No clinical evidence of distant metastases

    • No suspicious manifestation of metastases that cannot be ruled out by x-ray, MRI, or CT scan, including the following:

      • Skeletal pain of unknown cause
      • Elevated alkaline phosphatase
      • Bone scan showing hot spots
  • No palpable axillary lymph node(s)
  • No Paget's disease without invasive cancer

  • Hormone receptor status:

    • Estrogen receptor and progesterone receptor known

PATIENT CHARACTERISTICS:

Age

  • Any age

Sex

  • Female

Menopausal status

  • Any status

Performance status

  • Not specified

Life expectancy

  • Not specified

Hematopoietic

  • Not specified

Hepatic

  • See Disease Characteristics

Renal

  • Not specified

Other

  • Not pregnant or nursing

  • No other prior or concurrent malignancy except the following:

    • Adequately treated basal cell or squamous cell skin cancer
    • Adequately treated carcinoma in situ of the cervix
    • Adequately treated in situ melanoma
    • Contralateral or ipsilateral carcinoma in situ of the breast
  • No psychiatric, addictive, or other disorder that may compromise ability to give informed consent
  • Geographically accessible for follow-up

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • Not specified

Endocrine therapy

  • Not specified

Radiotherapy

  • Not specified

Surgery

  • See Disease Characteristics

Other

  • No prior systemic therapy for breast cancer
  • More than 1 year since prior chemopreventive agent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Axillary Dissection
Patients undergo surgical resection of the primary tumor with axillary lymph node dissection following sentinel lymph node assessment.
Procedure: Axillary lymph node dissection
Axillary lymph node dissection
Experimental: No Axillary Dissection
Patients undergo surgical resection of the primary tumor with no axillary lymph node dissection following sentinel lymph node assessment.
Procedure: No axillary lymph node dissection
Therapeutic conventional surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
5-year Disease-Free Survival
Time Frame: 5-year estimate reported after a median follow-up of 60 months
Estimated percentage of patients alive and disease-free at 5 years from randomization, where disease-free survival is defined as the time from randomization to first evidence of invasive relapse at any site, second primary tumor (contralateral or non-breast) or death.
5-year estimate reported after a median follow-up of 60 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
5-year Overall Survival
Time Frame: 5-year estimate reported after a median follow-up of 60 months
Estimated percentage of patients alive and disease-free at 5 years from randomization, where overall survival is defined as the time from randomization to death of any cause.
5-year estimate reported after a median follow-up of 60 months
Site of Recurrence
Time Frame: Reported after a median follow-up of 60 months
Site of recurrence of breast cancer
Reported after a median follow-up of 60 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ETOP IBCSG Partners Foundation

Investigators

  • Study Chair: Viviana E. Galimberti, European Institute of Oncology
  • Study Chair: Umberto Veronesi, MD, Prof., European Institute of Oncology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2001

Primary Completion (Actual)

September 1, 2012

Study Completion (Actual)

March 31, 2017

Study Registration Dates

First Submitted

November 4, 2003

First Submitted That Met QC Criteria

November 5, 2003

First Posted (Estimate)

November 6, 2003

Study Record Updates

Last Update Posted (Actual)

January 23, 2018

Last Update Submitted That Met QC Criteria

December 22, 2017

Last Verified

December 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000339581
  • IBCSG 23-01 (Other Identifier: IBCSG)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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