Comparison of Complete Axillary Lymph Node Dissection With Axillary Radiation Therapy in Treating Women With Invasive Breast Cancer (AMAROS)

After Mapping Of The Axilla: Radiotherapy Or Surgery

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells and may be a less invasive treatment and cause fewer side effects than complete axillary lymph node dissection. It is not yet known which treatment is more effective for invasive breast cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of complete axillary lymph node dissection with that of axillary radiation therapy in treating women who have invasive breast cancer.

Study Overview

Detailed Description

OBJECTIVES:

  • Compare the regional control of the axilla obtained by complete axillary lymph node dissection vs axillary radiotherapy in sentinel lymph node-positive women with operable invasive breast cancer.
  • Determine whether local and regional axillary control can be obtained without axillary lymph node dissection in sentinel lymph node-negative women.
  • Compare the axillary 5-year recurrence-free survival of these patients treated with these regimens.
  • Compare the morbidity of patients treated with these regimens.
  • Compare the quality of life of these patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center and type of breast surgery (conservation vs total mastectomy). Patients are randomized to 1 of 2 treatment arms.

Patients are given an injection of a tracer and undergo lymphoscintigraphy 2-3 hours later to identify the sentinel lymph node. Within 24 hours after lymphoscintigraphy, patients undergo wide local excision of the tumor or mastectomy after the sentinel node is removed. If no sentinel node is found or metastasis is found in a nonsentinel node, patients undergo complete axillary lymph node dissection (ALND) regardless of randomization. Sentinel node-negative patients receive no further treatment. Sentinel node-positive patients continue treatment according to randomization.

  • Arm I: Within 8 weeks after surgery, patients undergo complete ALND.
  • Arm II: Within 8 weeks after surgery, patients undergo axillary lymph node radiotherapy daily 5 days a week for 5 weeks.

Patients in arm I may receive postoperative axillary irradiation if 4 or more nodes are positive and more than 1 axillary level is involved.

Quality of life is assessed at baseline and then at 1, 2, 3, and 5 years.

Patients are followed annually for 5 years.

PROJECTED ACCRUAL: A total of 3,485 patients (1,394 sentinel node-positive and 2,091 sentinel node-negative) will be accrued for this study within 3 years.

Study Type

Interventional

Enrollment (Actual)

4813

Phase

  • Phase 3

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

      • Grenoble, France, 38043
        • CHU de Grenoble - Hopital de la Tronche
      • Lille, France, 59020
        • Centre Oscar Lambret
      • Firenze (Florence), Italy, 1 (50134)
        • Universita Degli Studi di Florence - Policlinico di Careggi
      • Turin, Italy, 10123
        • Azienda Sanitaria Ospedale San Giovanni Battista Molinette di Torino
      • 's-Gravenhage, Netherlands, 2545 CH
        • HagaZiekenhuis - Locatie Leyenburg
      • Amstelveen, Netherlands, 1180AH
        • Ziekenhuis Amstelland
      • Amsterdam, Netherlands, 1066 CX
        • Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital
      • Amsterdam, Netherlands, 1105 AZ
        • Academisch Medisch Centrum at University of Amsterdam
      • Apeldoorn, Netherlands, 7334 DZ
        • Gelre Ziekenhuizen - Lokatie Lukas
      • Arnhem, Netherlands, 6800 TA
        • Rijnstate Hospital
      • Delft, Netherlands, NL 2600 GA
        • Reinier de Graaf Group - Delft
      • Den Haag, Netherlands, 2597AX
        • Ziekenhuis Bronovo
      • Den Haag, Netherlands, 2566 MJ
        • HagaZiekenhuis - Locatie Rode Kruis
      • Drachten, Netherlands, NL-9200 DA
        • Nij Smellinghe
      • Eindhoven, Netherlands, 5602 ZA
        • Catharina Ziekenhuis
      • Groningen, Netherlands, 9713 EZ
        • University Medical Center Groningen
      • Haarlem, Netherlands, 2000
        • Kennemer Gasthuis - Locatie EG
      • Hardenberg, Netherlands, 7770
        • Ropcke-Zweers Ziekenhuis
      • Harderwijk, Netherlands, 3840 AC
        • Ziekenhuis St. Jansdal
      • Leiden, Netherlands, 2300 CA
        • Leiden University Medical Center
      • Nijmegen, Netherlands, NL-6500 HB
        • Universitair Medisch Centrum St. Radboud - Nijmegen
      • Roermond, Netherlands, 6043 CV
        • Saint Laurentius Ziekenhuis
      • Utrecht, Netherlands, 3584 CX
        • University Medical Center Utrecht
      • Gdansk, Poland, 80-211
        • Medical University of Gdansk
      • Ljubljana, Slovenia, Sl-1000
        • Institute of Oncology - Ljubljana
      • Geneva, Switzerland, CH-1211
        • Hôpital Cantonal Universitaire de Genève
      • Istanbul, Turkey, 81190
        • Marmara University Hospital
    • England
      • Manchester, England, United Kingdom, M23 9LJ
        • Wythenshawe Hospital
    • Wales
      • Cardiff, Wales, United Kingdom, CF14 4XN
        • University Hospital of Wales

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

DISEASE CHARACTERISTICS:

  • Histologically or "triple diagnosis" (palpation, mammogram or ultrasound, and cytology) confirmed operable invasive breast cancer

    • T0-2, N0
    • Diagnosis by excisional tumorectomy allowed
    • Clinically occult invasive disease must be histologically confirmed
  • Only 1 tumor in 1 breast

    • Tumor between 5 and 50 mm in largest diameter, within 1 quadrant by mammogram, ultrasound or MRI

      • Multifocal (i.e., within one quadrant and sharing the same histological characteristics) is allowed
      • Multicentric (i.e., in different quadrants) breast cancer is not allowed
  • Clinically negative axillary lymph nodes
  • No metastatic disease
  • No previous treatment of the primary breast tumor by neoadjuvant hormonal or systemic treatment
  • Hormone receptor status:

    • Not specified

PATIENT CHARACTERISTICS:

Age:

  • Any age

Sex:

  • Female

Menopausal status:

  • Not specified

Performance status:

  • Not specified

Life expectancy:

  • Not specified

Hematopoietic:

  • Not specified

Hepatic:

  • Not specified

Renal:

  • Not specified

Other:

  • Fit to undergo sentinel node biopsy, axillary clearance, breast surgery, and/or axillary radiotherapy
  • No psychological, familial, sociological, or geographical condition that would preclude study compliance
  • No other prior malignancy except basal cell skin cancer or carcinoma in situ of the cervix
  • Not pregnant

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • Not specified

Endocrine therapy:

  • Not specified

Radiotherapy:

  • No prior radiotherapy to axilla

Surgery:

  • No prior surgery to axilla

Other:

  • See Disease Characteristics

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 lymph node dissection
complete axillary lymph node dissection
Experimental: axillary radiotherapy
axillary radiotherapy, daily for 5 days a week, for 5 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Axillary recurrence rate
Time Frame: from randomization
from randomization

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall survival
Time Frame: from randomization
from randomization
Shoulder function as assessed by arm function test questionnaire at baseline, 1, 3, and 5 years after surgery
Time Frame: from randomization
from randomization
Quality of life as measured by Quality of Life Questionnaire Core 30 Items (QLQ-C30) and QLQ-BR25 at baseline, 1, 2, 3, and 5 years after surgery
Time Frame: from randomization
from randomization
Axillary recurrence-free survival
Time Frame: from randomization
from randomization
Disease-free survival
Time Frame: from randomization
from randomization

Collaborators and Investigators

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

Investigators

  • Study Chair: Emiel JT Rutgers, The Netherlands Cancer Institute
  • Study Chair: Robert Mansel, Cardiff and Vale University Health Board - University Hospital of Wales, Cardiff
  • Study Chair: Cornelis Van De Velde, Leiden University Medical Centre, Leiden
  • Study Chair: Geertjan Van Tienhoven, Academisch Medisch Centrum - Universiteit van Amsterdam, Amsterdam

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

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

February 1, 2001

Primary Completion (Actual)

November 1, 2010

Study Completion (Actual)

March 1, 2013

Study Registration Dates

First Submitted

April 10, 2001

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimate)

January 27, 2003

Study Record Updates

Last Update Posted (Estimate)

October 29, 2013

Last Update Submitted That Met QC Criteria

October 28, 2013

Last Verified

October 1, 2013

More Information

Terms related to this study

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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