Condition category
Cancer
Date applied
29/04/2010
Date assigned
29/04/2010
Last edited
27/11/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Mrs Christine Morris

ORCID ID

Contact details

Cardiff & Vale Breast Centre
University Hospital Llandough
Llandough
Cardiff
CF64 2XX
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

1424; EORTC 10981-22023

Study information

Scientific title

A phase III study comparing a complete axillary lymph node dissection with radiotherapy to the axilla in sentinel biopsy positive patients

Acronym

EORTC 10981 (AMAROS)

Study hypothesis

After mapping of the axillary: radiotherapy or surgery, is a phase III study comparing a complete axillary lymph node dissection with radiotherapy to the axilla in sentinel biopsy positive patients, where-as sentinel node negative patients are followed for the end-points of the study as well.

Ethics approval

Multi-Centre Research Ethics Committee for Wales approved on the 22nd October 2005 (ref: 05/MRE09/61)

Study design

Randomised interventional treatment trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Topic: National Cancer Research Network; Subtopic: Breast Cancer; Disease: Breast

Intervention

Patients will be stratified by institution and will be randomised between complete axillary lymph node dissection and radiotherapy of the axilla.

Follow up length: 5 years
Study entry: single randomisation only

Intervention type

Other

Phase

Phase III

Drug names

Primary outcome measures

Axillary recurrence rate after 5 years.

Secondary outcome measures

1. Shoulder function analysis
2. Quality of life
3. Arm circumference

Node positive patients have annual examination and mammograms for 10 years. Quality of life questionnaire, arm circumference and shoulder function measurements measured at 1, 2, 3, 5 and 10 years.

Overall trial start date

08/03/2007

Overall trial end date

01/05/2010

Reason abandoned

Eligibility

Participant inclusion criteria

1. Invasive breast cancer proven by core biopsy or 'triple diagnosis': clinical palpation concordant with malignancy, imaging (mammography or ultrasound) and tumour positive FNA cytology; diagnosis by excisional tumourectomy is allowed. Clinically occult invasive cancer should be proven by histology.
2. Tumour larger than 5 and smaller than 30 mm in its largest diameter, measured by mammography or ultrasound, only one tumour site (palpation, mammogram or ultrasound) in one breast: bilateral unifocal invasive breast cancer is allowed, (bilateral mammogram is mandatory)
3. Clinically negative axillary lymph nodes
4. Patient has to be fit to undergo any of the following treatments: SN-biopsy, axillary clearance, breast surgery, radiation therapy of the axilla
5. Before patient registration/randomisation, informed consent must be obtained according to ICH/EU GCP, and national/local regulations
6. Female, all ages considered
7. Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
8. No metastatic disease (routine investigations are not required: symptoms should be investigated on indication)
9. No previous treatment of the axilla by surgery or radiotherapy
10. No previous treatment of cancer, except Basal Cell Carcinoma of the skin and in situ carcinoma of the cervix
11. No pregnancy

Participant type

Patient

Age group

Other

Gender

Female

Target number of participants

Planned Sample Size: 4500; UK Sample Size: 600

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

08/03/2007

Recruitment end date

01/05/2010

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Cancer Trials Unit
Cardiff
CF14 4XN
United Kingdom

Sponsor information

Organisation

European Organisation for Research and Treatment of Cancer (EORTC) (Belgium)

Sponsor details

Avenue Mounierlaan
83/11
Brussels
1200
Belgium
+32 2 774 16 11
eortc@eortc.be

Sponsor type

Research organisation

Website

http://www.eortc.be/

Funders

Funder type

Research organisation

Funder name

European Organisation for Research and Treatment of Cancer (EORTC) (Belgium)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2014 results in http://www.ncbi.nlm.nih.gov/pubmed/25439688

Publication citations

Additional files

Editorial Notes

27/11/2015: Publication reference added.