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

This study has been completed.
Sponsor:
Collaborators:
ALMANAC Trialists Group
Borstkanker Onderzoeksgroup Nederland
Information provided by (Responsible Party):
European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier:
NCT00014612
First received: April 10, 2001
Last updated: October 28, 2013
Last verified: October 2013
  Purpose

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 Intervention Phase
Breast Cancer
Procedure: axillary lymph node dissection
Procedure: lymphoscintigraphy
Procedure: therapeutic conventional surgery
Radiation: radiation therapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: After Mapping Of The Axilla: Radiotherapy Or Surgery

Resource links provided by NLM:


Further study details as provided by European Organisation for Research and Treatment of Cancer - EORTC:

Primary Outcome Measures:
  • Axillary recurrence rate [ Time Frame: from randomization ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Shoulder function as assessed by arm function test questionnaire at baseline, 1, 3, and 5 years after surgery [ Time Frame: from randomization ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Axillary recurrence-free survival [ Time Frame: from randomization ] [ Designated as safety issue: No ]
  • Disease-free survival [ Time Frame: from randomization ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: from randomization ] [ Designated as safety issue: No ]

Enrollment: 4813
Study Start Date: February 2001
Study Completion Date: March 2013
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00014612

Locations
France
CHU de Grenoble - Hopital de la Tronche
Grenoble, France, 38043
Centre Oscar Lambret
Lille, France, 59020
Italy
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
Netherlands
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
Ziekenhuis Bronovo
Den Haag, Netherlands, 2597AX
HagaZiekenhuis - Locatie Rode Kruis
Den Haag, Netherlands, 2566 MJ
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
Poland
Medical University of Gdansk
Gdansk, Poland, 80-211
Slovenia
Institute of Oncology - Ljubljana
Ljubljana, Slovenia, Sl-1000
Switzerland
Hopital Cantonal Universitaire de Geneve
Geneva, Switzerland, CH-1211
Turkey
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
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
  More Information

Additional Information:
Publications:
Additional 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
Study First Received: April 10, 2001
Last Updated: October 28, 2013
Health Authority: United States: Federal Government

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
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on October 19, 2014