AMAROS.

Trial name or title	AMAROS
Methods	Study design: RCT (multi‐centre, non‐inferiority) Country: Europe
Participants	Inclusion criteria: patients with operable unifocal invasive breast cancer (5‐30 mm) and clinically node negative Exclusion criteria: metastatic disease, previous treatment of the axilla by surgery or radiotherapy, previous treatment of cancer (except basal cell carcinoma of the skin and in situ carcinoma of the cervix), pregnancy
Interventions	Women were randomised before surgery and SLNB to the treatment they would receive if their SLNB proved positive. Women with negative SLNB received no additional treatment. Those with a positive lymph node received axillary lymph node dissection (level I and II) or axillary radiation therapy. Patients could also receive adjuvant systemic chemo/endocrine therapy according to local guidelines.
Outcomes	Regional control, survival, long‐term morbidity
Starting date	2001
Contact information	Emiel Rutgers, The Netherlands Cancer Institute, Plesmanlaan 121, 1066 CX Amsterdam, Netherlands. Email: e.rutgers@nki.nl
Notes	Target number of participants is 4766; up until December 2008, more than 4000 participants had been enrolled.