Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Treatment	Active	Any age	Other	EORTC-10981 EORTC-10981-AMAROS, NCT00014612

Objectives

1. 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.
2. Determine whether local and regional axillary control can be obtained without axillary lymph node dissection in sentinel lymph node-negative women.
3. Compare the axillary 5-year recurrence-free survival of these patients treated with these regimens.
4. Compare the morbidity of patients treated with these regimens.
5. Compare the quality of life of these patients treated with these regimens.

Entry Criteria

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

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

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

Expected Enrollment

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.

Outcomes

Axillary recurrence rate

Shoulder function as assessed by arm function test questionnaire at baseline, 1, 3, and 5 years after surgery
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
Axillary recurrence-free survival
Disease-free survival
Overall survival

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.

Straver ME, Meijnen P, van Tienhoven G, et al.: Technical aspects of the sentinel node biopsy in the EORTC AMAROS sentinel node trial. [Abstract] 31st Annual San Antonio Breast Cancer Symposium, December 10-14, 2008, San Antonio, Texas. A-1006, 2008.

Meijnen P, Rutgers EJT, van de Velde CJH, et al.: EORTC 10981-22023 trial. AMAROS: after mapping of the axilla: radiotherapy or surgery? Trial update. [Abstract] Eur J Cancer 2 (Suppl 3): A-79, 79, 2004.

Hurkmans CW, Borger JH, Rutgers EJ, et al.: Quality assurance of axillary radiotherapy in the EORTC AMAROS trial 10981/22023: the dummy run. Radiother Oncol 68 (3): 233-40, 2003.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

European Organization for Research and Treatment of Cancer

Emiel Rutgers, MD, PhD, FRCS, Study coordinator		Ph: 31-20-512-2551

France
	Grenoble
	CHU de Grenoble - Hopital de la Tronche
		Contact Person	Ph:  33-4-7676-5537
	Lille
	Centre Oscar Lambret
		Contact Person	Ph:  33-20-29-5959
Italy
	Firenze (Florence)
	Universita Degli Studi di Florence - Policlinico di Careggi
		Contact Person	Ph:  39-43-780-51
	Turin
	Azienda Sanitaria Ospedale San Giovanni Battista Molinette di Torino
		Contact Person	Ph:  39-575-4821
Netherlands
	Amstelveen
	Ziekenhuis Amstelland
		Contact Person	Ph:  31-020-347-4481
	Amsterdam
	Academisch Medisch Centrum at University of Amsterdam
		Contact Person	Ph:  31-20-566-9111
	Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital
		Contact Person	Ph:  31-20-512-9111
	Apeldoorn
	Gelre Ziekenhuizen - Lokatie Lukas
		Contact Person	Ph:  31-55-581-8181
	Arnhem
	Rijnstate Hospital
		Contact Person	Ph:  31-26-378-8888
	Delft
	Reinier de Graaf Group - Delft
		Contact Person	Ph:  31-15-260-3060
	Den Haag
	HagaZiekenhuis - Locatie Rode Kruis
		Contact Person	Ph:  31-70-360-8068
	Ziekenhuis Bronovo
		Contact Person	Ph:  31-070-312-4141
	Drachten
	NIJ Smellinghe
		Contact Person	Ph:  31-512-588-888
	Eindhoven
	Catharina Ziekenhuis
		Contact Person	Ph:  31-40-239-9111
	Groningen
	University Medical Center Groningen
		Contact Person	Ph:  31-50-361-6161
	Haarlem
	Kennemer Gasthuis - Locatie EG
		Contact Person
			Email: info@kg.nl
	Hardenberg
	Ropcke-Zweers Ziekenhuis
		Contact Person	Ph:  31-523-27-6000
	Harderwijk
	Ziekenhuis St. Jansdal
		Contact Person	Ph:  31-341-463-911
	Leiden
	Leiden University Medical Center
		Contact Person	Ph:  31-71-526-911
	Nijmegen
	Universitair Medisch Centrum St. Radboud - Nijmegen
		Contact Person	Ph:  31-24-361-5215
	Roermond
	Saint Laurentius Ziekenhuis
		Contact Person	Ph:  31-475-382-466
	's-Gravenhage
	HagaZiekenhuis - Locatie Leyenburg
		Contact Person	Ph:  31-70-359-2653
	Utrecht
	University Medical Center Utrecht
		Contact Person	Ph:  31-30-250-6266
Poland
	Gdansk
	Medical University of Gdansk
		Contact Person	Ph:  48-58-349-2000
Slovenia
	Ljubljana
	Institute of Oncology - Ljubljana
		Contact Person	Ph:  386-1-323-063
Switzerland
	Geneva
	Hopital Cantonal Universitaire de Geneve
		Contact Person	Ph:  41-22-372-4018
Turkey
	Istanbul
	Marmara University Hospital
		Contact Person	Ph:  90-216-327-4142
United Kingdom
England
	Manchester
	Wythenshawe Hospital
		Contact Person	Ph:  44-161-998-7070
Wales
	Cardiff
	University Hospital of Wales
		Contact Person	Ph:  44-29-2074-2896

Registry Information
Official Title		After Mapping Of The Axilla: Radiotherapy Or Surgery
Trial Start Date		2001-02-15
Trial Completion Date		2012-12-31 (estimated)
Registered in ClinicalTrials.gov		NCT00014612
Date Submitted to PDQ		2001-02-23
Information Last Verified		2009-07-21

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