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

NCT00014612 | Completed Phase 3

• 1 other identifier: EORTC-10981-22023
• Study Type: interventional
• Target: 4,813
• Locations: 8 countries
• Sites: 29

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.

Conditions

Breast Cancer

Keywords

stage IA breast cancer; stage IB breast cancer; stage II breast cancer

Outcome Measures

Primary Outcomes (1)

• Axillary recurrence rate

  from randomization

Secondary Outcomes (5)

• Shoulder function as assessed by arm function test questionnaire at baseline, 1, 3, and 5 years after surgery

  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

  from randomization

• Axillary recurrence-free survival

  from randomization

• Disease-free survival

  from randomization

• Overall survival

  from randomization

Study Arms (2)

axillary lymph node dissection

ACTIVE COMPARATOR

complete axillary lymph node dissection

Procedure: axillary lymph node dissection; Procedure: lymphoscintigraphy; Procedure: therapeutic conventional surgery

axillary radiotherapy

EXPERIMENTAL

axillary radiotherapy, daily for 5 days a week, for 5 weeks

Procedure: lymphoscintigraphy; Procedure: therapeutic conventional surgery; Radiation: radiation therapy

Interventions

axillary lymph node dissection PROCEDURE

axillary lymph node dissection

lymphoscintigraphy PROCEDURE

axillary lymph node dissection; axillary radiotherapy

therapeutic conventional surgery PROCEDURE

axillary lymph node dissection; axillary radiotherapy

radiation therapy RADIATION

axillary radiotherapy

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• European Organisation for Research and Treatment of Cancer - EORTC: lead
• ALMANAC Trialists Group: collaborator
• Borstkanker Onderzoeksgroup Nederland: collaborator

Study Sites (29)

CHU de Grenoble - Hopital de la Tronche

Grenoble, 38043, France

Location

Centre Oscar Lambret

Lille, 59020, France

Location

Universita Degli Studi di Florence - Policlinico di Careggi

Firenze (Florence), 1 (50134), Italy

Location

Azienda Sanitaria Ospedale San Giovanni Battista Molinette di Torino

Turin, 10123, Italy

Location

Ziekenhuis Amstelland

Amstelveen, 1180AH, Netherlands

Location

Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital

Amsterdam, 1066 CX, Netherlands

Location

Academisch Medisch Centrum at University of Amsterdam

Amsterdam, 1105 AZ, Netherlands

Location

Gelre Ziekenhuizen - Lokatie Lukas

Apeldoorn, 7334 DZ, Netherlands

Location

Rijnstate Hospital

Arnhem, 6800 TA, Netherlands

Location

Reinier de Graaf Group - Delft

Delft, NL 2600 GA, Netherlands

Location

NIJ Smellinghe

Drachten, NL-9200 DA, Netherlands

Location

Catharina Ziekenhuis

Eindhoven, 5602 ZA, Netherlands

Location

University Medical Center Groningen

Groningen, 9713 EZ, Netherlands

Location

Kennemer Gasthuis - Locatie EG

Haarlem, 2000, Netherlands

Location

Ropcke-Zweers Ziekenhuis

Hardenberg, 7770, Netherlands

Location

Ziekenhuis St. Jansdal

Harderwijk, 3840 AC, Netherlands

Location

Leiden University Medical Center

Leiden, 2300 CA, Netherlands

Location

Universitair Medisch Centrum St. Radboud - Nijmegen

Nijmegen, NL-6500 HB, Netherlands

Location

Saint Laurentius Ziekenhuis

Roermond, 6043 CV, Netherlands

Location

HagaZiekenhuis - Locatie Leyenburg

The Hague, 2545 CH, Netherlands

Location

HagaZiekenhuis - Locatie Rode Kruis

The Hague, 2566 MJ, Netherlands

Location

Ziekenhuis Bronovo

The Hague, 2597AX, Netherlands

Location

University Medical Center Utrecht

Utrecht, 3584 CX, Netherlands

Location

Medical University of Gdansk

Gdansk, 80-211, Poland

Location

Institute of Oncology - Ljubljana

Ljubljana, Sl-1000, Slovenia

Location

Hopital Cantonal Universitaire de Geneve

Geneva, CH-1211, Switzerland

Location

Marmara University Hospital

Istanbul, 81190, Turkey (Türkiye)

Location

Wythenshawe Hospital

Manchester, England, M23 9LJ, United Kingdom

Location

University Hospital of Wales

Cardiff, Wales, CF14 4XN, United Kingdom

Location

Related Publications (8)

• Straver ME, Meijnen P, van Tienhoven G, van de Velde CJ, Mansel RE, Bogaerts J, Demonty G, Duez N, Cataliotti L, Klinkenbijl J, Westenberg HA, van der Mijle H, Hurkmans C, Rutgers EJ. Role of axillary clearance after a tumor-positive sentinel node in the administration of adjuvant therapy in early breast cancer. J Clin Oncol. 2010 Feb 10;28(5):731-7. doi: 10.1200/JCO.2008.21.7554. Epub 2009 Dec 28.

  PMID: 20038733 RESULT

• Straver ME, Meijnen P, van Tienhoven G, van de Velde CJ, Mansel RE, Bogaerts J, Duez N, Cataliotti L, Klinkenbijl JH, Westenberg HA, van der Mijle H, Snoj M, Hurkmans C, Rutgers EJ. Sentinel node identification rate and nodal involvement in the EORTC 10981-22023 AMAROS trial. Ann Surg Oncol. 2010 Jul;17(7):1854-61. doi: 10.1245/s10434-010-0945-z. Epub 2010 Mar 19.

  PMID: 20300966 RESULT

• 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.

  RESULT

• 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.

  RESULT

• Hurkmans CW, Borger JH, Rutgers EJ, van Tienhoven G; EORTC Breast Cancer Cooperative Group; Radiotherapy Cooperative Group. Quality assurance of axillary radiotherapy in the EORTC AMAROS trial 10981/22023: the dummy run. Radiother Oncol. 2003 Sep;68(3):233-40. doi: 10.1016/s0167-8140(03)00194-4.

  PMID: 13129630 RESULT

• Donker M, Slaets L, van Tienhoven G, Rutgers EJ. [Axillary lymph node dissection versus axillary radiotherapy in patients with a positive sentinel node: the AMAROS trial]. Ned Tijdschr Geneeskd. 2015;159:A9302. Dutch.

  PMID: 26488192 DERIVED

• Donker M, van Tienhoven G, Straver ME, Meijnen P, van de Velde CJ, Mansel RE, Cataliotti L, Westenberg AH, Klinkenbijl JH, Orzalesi L, Bouma WH, van der Mijle HC, Nieuwenhuijzen GA, Veltkamp SC, Slaets L, Duez NJ, de Graaf PW, van Dalen T, Marinelli A, Rijna H, Snoj M, Bundred NJ, Merkus JW, Belkacemi Y, Petignat P, Schinagl DA, Coens C, Messina CG, Bogaerts J, Rutgers EJ. Radiotherapy or surgery of the axilla after a positive sentinel node in breast cancer (EORTC 10981-22023 AMAROS): a randomised, multicentre, open-label, phase 3 non-inferiority trial. Lancet Oncol. 2014 Nov;15(12):1303-10. doi: 10.1016/S1470-2045(14)70460-7. Epub 2014 Oct 15.

  PMID: 25439688 DERIVED

• Donker M, Straver ME, van Tienhoven G, van de Velde CJ, Mansel RE, Litiere S, Werutsky G, Duez NJ, Orzalesi L, Bouma WH, van der Mijle H, Nieuwenhuijzen GA, Veltkamp SC, Helen Westenberg A, Rutgers EJ. Comparison of the sentinel node procedure between patients with multifocal and unifocal breast cancer in the EORTC 10981-22023 AMAROS Trial: identification rate and nodal outcome. Eur J Cancer. 2013 Jun;49(9):2093-100. doi: 10.1016/j.ejca.2013.02.017. Epub 2013 Mar 19.

  PMID: 23522754 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• 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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2001
• First Posted: January 27, 2003
• Study Start: February 1, 2001
• Primary Completion: November 1, 2010
• Study Completion: March 1, 2013
• Last Updated: October 29, 2013

Record last verified: 2013-10

Locations

SL (1); CH (1); GB (2); FR (2); TU (1); IT (2); PL (1); NL (19)