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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00014612
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : October 29, 2013
Information provided by (Responsible Party):

Study Description
Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Procedure: axillary lymph node dissection Procedure: lymphoscintigraphy Procedure: therapeutic conventional surgery Radiation: radiation therapy Phase 3

Detailed Description:


  • 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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4813 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: After Mapping Of The Axilla: Radiotherapy Or Surgery
Study Start Date : February 2001
Primary Completion Date : November 2010
Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: axillary lymph node dissection
complete axillary lymph node dissection
Procedure: axillary lymph node dissection Procedure: lymphoscintigraphy Procedure: therapeutic conventional surgery
Experimental: axillary radiotherapy
axillary radiotherapy, daily for 5 days a week, for 5 weeks
Procedure: lymphoscintigraphy Procedure: therapeutic conventional surgery Radiation: radiation therapy

Outcome Measures

Primary Outcome Measures :
  1. Axillary recurrence rate [ Time Frame: from randomization ]

Secondary Outcome Measures :
  1. Shoulder function as assessed by arm function test questionnaire at baseline, 1, 3, and 5 years after surgery [ Time Frame: from randomization ]
  2. 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 ]
  3. Axillary recurrence-free survival [ Time Frame: from randomization ]
  4. Disease-free survival [ Time Frame: from randomization ]
  5. Overall survival [ Time Frame: from randomization ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No


  • 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



  • Any age


  • Female

Menopausal status:

  • Not specified

Performance status:

  • Not specified

Life expectancy:

  • Not specified


  • Not specified


  • Not specified


  • Not specified


  • 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


Biologic therapy:

  • Not specified


  • Not specified

Endocrine therapy:

  • Not specified


  • No prior radiotherapy to axilla


  • No prior surgery to axilla


  • See Disease Characteristics
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00014612

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier: NCT00014612     History of Changes
Other Study ID Numbers: EORTC-10981-22023
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: October 29, 2013
Last Verified: October 2013

Keywords provided by European Organisation for Research and Treatment of Cancer - EORTC:
stage IA breast cancer
stage IB breast cancer
stage II breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases