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

Breast Cancer Clinical Trial

— AMAROS  

Official title:

After Mapping Of The Axilla: Radiotherapy Or Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00014612
• Other study ID #: EORTC-10981-22023
• Status: Completed
• Phase: Phase 3
• First received: April 10, 2001
• Last updated: October 28, 2013
• Start date: February 2001
• Est. completion date: March 2013

Study information

• Verified date: October 2013
• Source: European Organisation for Research and Treatment of Cancer - EORTC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4813
• Est. completion date: March 2013
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Procedure:
• axillary lymph node dissection

• lymphoscintigraphy

• therapeutic conventional surgery

Radiation:
• radiation therapy

Locations

Country	Name	City	State
France	CHU de Grenoble - Hopital de la Tronche	Grenoble
France	Centre Oscar Lambret	Lille
Italy	Universita Degli Studi di Florence - Policlinico di Careggi	Firenze (Florence)
Italy	Azienda Sanitaria Ospedale San Giovanni Battista Molinette di Torino	Turin
Netherlands	HagaZiekenhuis - Locatie Leyenburg	's-Gravenhage
Netherlands	Ziekenhuis Amstelland	Amstelveen
Netherlands	Academisch Medisch Centrum at University of Amsterdam	Amsterdam
Netherlands	Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital	Amsterdam
Netherlands	Gelre Ziekenhuizen - Lokatie Lukas	Apeldoorn
Netherlands	Rijnstate Hospital	Arnhem
Netherlands	Reinier de Graaf Group - Delft	Delft
Netherlands	HagaZiekenhuis - Locatie Rode Kruis	Den Haag
Netherlands	Ziekenhuis Bronovo	Den Haag
Netherlands	NIJ Smellinghe	Drachten
Netherlands	Catharina Ziekenhuis	Eindhoven
Netherlands	University Medical Center Groningen	Groningen
Netherlands	Kennemer Gasthuis - Locatie EG	Haarlem
Netherlands	Ropcke-Zweers Ziekenhuis	Hardenberg
Netherlands	Ziekenhuis St. Jansdal	Harderwijk
Netherlands	Leiden University Medical Center	Leiden
Netherlands	Universitair Medisch Centrum St. Radboud - Nijmegen	Nijmegen
Netherlands	Saint Laurentius Ziekenhuis	Roermond
Netherlands	University Medical Center Utrecht	Utrecht
Poland	Medical University of Gdansk	Gdansk
Slovenia	Institute of Oncology - Ljubljana	Ljubljana
Switzerland	Hopital Cantonal Universitaire de Geneve	Geneva
Turkey	Marmara University Hospital	Istanbul
United Kingdom	University Hospital of Wales	Cardiff	Wales
United Kingdom	Wythenshawe Hospital	Manchester	England

Sponsors (3)

Lead Sponsor	Collaborator
European Organisation for Research and Treatment of Cancer - EORTC	ALMANAC Trialists Group, Borstkanker Onderzoeksgroup Nederland

Countries where clinical trial is conducted

France,  Italy,  Netherlands,  Poland,  Slovenia,  Switzerland,  Turkey,  United Kingdom, 

References & Publications (5)

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):23 — View 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.

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.

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 — View 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 1098 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Axillary recurrence rate		from randomization	No
Secondary	Shoulder function as assessed by arm function test questionnaire at baseline, 1, 3, and 5 years after surgery		from randomization	No
Secondary	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	No
Secondary	Axillary recurrence-free survival		from randomization	No
Secondary	Disease-free survival		from randomization	No
Secondary	Overall survival		from randomization	No