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NCT00014612 · CITED IN SOURCE DOCUMENTS

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

An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.

Phase
PHASE3
Status at capture
COMPLETED
Registry last update
2013-10-29

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

No posted result sections were captured. Registered plans do not establish that a treatment works.

Who could take part
eligibility 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
healthy Volunteers
false
sex
FEMALE
std Ages
  1. CHILD
  2. ADULT
  3. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    complete axillary lymph node dissection
    intervention Names
    1. Procedure: axillary lymph node dissection
    2. Procedure: lymphoscintigraphy
    3. Procedure: therapeutic conventional surgery
    label
    axillary lymph node dissection
    type
    ACTIVE_COMPARATOR
  2. description
    axillary radiotherapy, daily for 5 days a week, for 5 weeks
    intervention Names
    1. Procedure: lymphoscintigraphy
    2. Procedure: therapeutic conventional surgery
    3. Radiation: radiation therapy
    label
    axillary radiotherapy
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. axillary lymph node dissection
    name
    axillary lymph node dissection
    type
    PROCEDURE
  2. arm Group Labels
    1. axillary lymph node dissection
    2. axillary radiotherapy
    name
    lymphoscintigraphy
    type
    PROCEDURE
  3. arm Group Labels
    1. axillary lymph node dissection
    2. axillary radiotherapy
    name
    therapeutic conventional surgery
    type
    PROCEDURE
  4. arm Group Labels
    1. axillary radiotherapy
    name
    radiation therapy
    type
    RADIATION
Study design
allocation
RANDOMIZED
intervention Model
PARALLEL
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
4813
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. measure
    Axillary recurrence rate
    time Frame
    from randomization
secondary Outcomes
  1. measure
    Shoulder function as assessed by arm function test questionnaire at baseline, 1, 3, and 5 years after surgery
    time Frame
    from randomization
  2. measure
    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. measure
    Axillary recurrence-free survival
    time Frame
    from randomization
  4. measure
    Disease-free survival
    time Frame
    from randomization
  5. measure
    Overall survival
    time Frame
    from randomization
Full 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.
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.
Source references
references
  1. citation
    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
    type
    RESULT
  2. citation
    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
    type
    RESULT
  3. citation
    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.
    type
    RESULT
  4. citation
    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.
    type
    RESULT
  5. citation
    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
    type
    RESULT
  6. citation
    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
    type
    DERIVED
  7. citation
    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
    type
    DERIVED
  8. citation
    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
    type
    DERIVED
Source notices and limitations
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        r DFS events (hazard ratio [HR], 0.78; 95% CI, 0.55&#8211;1.11).</li><li>No difference in OS was observed.</li></ul></div></li><li>The <a href="/clinicaltrials/NCT00014612">AMAROS</a> trial (NCT00014612) studied ALND and axillary radiation therapy after identification of a positive SLN.[<a href="#cit/section_4.33">33</a>][<a href
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        , 0.78; 95% CI, 0.55&#8211;1.11).</li><li>No difference in OS was observed.</li></ul></div></li><li>The <a href="/clinicaltrials/NCT00014612">AMAROS</a> trial (NCT00014612) studied ALND and axillary radiation therapy after identification of a positive SLN.[<a href="#cit/section_4.33">33</a>][<a href="/Common/PopUps/popDefinition.
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      source update dates
      1. context
        Updated: April 25, 2025
        datetime
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        display
        April 25, 2025

    Preserved source evidence · Not medical advice