- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00014612
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
Status
Conditions
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
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
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
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
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
General Publications
- 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.
- 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.
- 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, 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EORTC-10981-22023
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.
Clinical Trials on Breast Cancer
-
Northwestern UniversityEisai Inc.UnknownMale Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Triple-negative Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast Cancer | Estrogen Receptor-negative Breast Cancer | Progesterone Receptor-negative Breast Cancer | HER2-negative...United States
-
Rutgers, The State University of New JerseyNational Cancer Institute (NCI); Rutgers Cancer Institute of New JerseyActive, not recruitingStage IIIA Breast Cancer | Stage IIIB Breast Cancer | Triple-negative Breast Cancer | Stage IIA Breast Cancer | Stage IIB Breast Cancer | Stage IIIC Breast Cancer | Estrogen Receptor-negative Breast Cancer | Progesterone Receptor-negative Breast Cancer | HER2-negative Breast CancerUnited States
-
University of Southern CaliforniaNational Cancer Institute (NCI)TerminatedMale Breast Cancer | Stage IV Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast Cancer | Recurrent Breast CancerUnited States
-
University of WashingtonTerminatedBreast Cancer | Breast Cancer Stage I | Breast Cancer Stage II | Breast Cancer Stage III | Breast Cancer Stage IIB | Breast Cancer Stage IIA | Breast Cancer Stage IIIA | Breast Cancer Stage IIIB | Breast Cancer Stage IIIcUnited States
-
CelgeneCompletedBreast Cancer | Metastatic Breast Cancer | Stage IV Breast Cancer | Triple-negative Breast Cancer | Recurrent Breast Cancer | Breast Tumor | Cancer of the Breast | Triple-negative Metastatic Breast Cancer | Estrogen Receptor- Negative Breast Cancer | HER2- Negative Breast Cancer | Progesterone Receptor- Negative...United States, United Kingdom, Italy, Germany, Spain, Canada, Portugal, Australia, Austria, Greece, Brazil, France
-
University of Southern CaliforniaNational Cancer Institute (NCI)TerminatedHER2-positive Breast Cancer | Stage IV Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast Cancer | Recurrent Breast CancerUnited States
-
University of WashingtonNational Cancer Institute (NCI)CompletedHER2-positive Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Estrogen Receptor-negative Breast Cancer | Estrogen Receptor-positive Breast Cancer | Progesterone Receptor-negative Breast Cancer | Progesterone Receptor-positive Breast...United States
-
Baylor Breast Care CenterRecruitingBreast Cancer | Breast Neoplasm | Triple Negative Breast Cancer | Triple Negative Breast Neoplasms | HER2-positive Breast Cancer | Breast Cancer Stage II | Breast Cancer Female | Breast Cancer Stage III | Estrogen Receptor-positive Breast Cancer | Hormone Receptor-positive Breast Cancer | Breast Cancer InvasiveUnited States
-
Innocrin PharmaceuticalCompletedBreast Cancer | Advanced Breast Cancer | Metastatic Breast Cancer | Triple Negative Breast Cancer | Male Breast Cancer | ER+ Breast Cancer | Cancer of the BreastUnited States
-
University of Southern CaliforniaNational Cancer Institute (NCI)WithdrawnStage IV Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Triple-negative Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast Cancer | Recurrent Breast Cancer
Clinical Trials on radiation therapy
-
NRG OncologyNational Cancer Institute (NCI)RecruitingUnrectable or Locally Recurrent Hepatocellular CarcinomaUnited States
-
University of California, San FranciscoVarian Medical SystemsRecruitingStage IV Anal Cancer AJCC v8 | Metastatic Gastroesophageal Junction Adenocarcinoma | Metastatic Colorectal Carcinoma | Stage IV Colorectal Cancer AJCC v8 | Stage IVA Colorectal Cancer AJCC v8 | Stage IVB Colorectal Cancer AJCC v8 | Stage IVC Colorectal Cancer AJCC v8 | Postneoadjuvant Therapy Stage... and other conditionsUnited States
-
Children's Oncology GroupNational Cancer Institute (NCI)CompletedBrain Tumor | Central Nervous System TumorUnited States, Canada, Australia, Puerto Rico, Switzerland, New Zealand
-
Medical College of WisconsinRecruitingHead and Neck CancerUnited States
-
Medical College of WisconsinRecruitingResectable Head and Neck Squamous Cell CarcinomaUnited States
-
Mayo ClinicNational Cancer Institute (NCI)Completed
-
Changhai HospitalRecruitingLocalized Prostate CancerChina
-
NYU Langone HealthCompletedBreast CancerUnited States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)CompletedAnn Arbor Stage II Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue | Ann Arbor Stage I Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue | Extranodal Marginal Zone LymphomaUnited States
-
Medical College of WisconsinActive, not recruitingHigh-Dose Lymph Node Intensity Modulated Radiation Therapy and Hypofractionated Prostate (SIB) (SIB)Prostate CancerUnited States