Randomized trials of sentinel lymph node biopsy
| Study | Population | Comparison arms | Trial status |
|---|---|---|---|
| Milan (47) | T1 tumours | SLNB; SLNB + ALND | Completed |
| GIVOM (48) | T < 3 cm | ALND; SLNB | Completed |
| NSABP-B32 | T1–3 tumours | SLNB; SLNB + ALND | Closed, technical report published only |
| ACOSOG Z0010 | T1–2 tumours | SLNB and bone marrow aspiration (no comparison arm) | Closed |
| ALMANAC (33) | Any T | SLNB; SLNB + ALND or 4 node sampling | Closed, quality of life data published |
| ACOSOG Z0011 | T1,2 with positive SLN | ALND; no further surgery | Closed early owing to poor accrual |
| IBCSG 23–01 | T1,2 tumours with micrometastases < 2 mm found in SLN | ALND; no further surgery | Open |
| AMAROS | T1,2 with positive SLN | ALND; RT to axilla level I/II | Open |
ACOSOG Z0010 = American College of Surgeons Oncology Group prognostic study of sentinel node and bone marrow micrometastases in women with clinical T1 or T2 N0 M0 breast cancer; ACOSOG Z0011 = American College of Surgeons Oncology Group randomized trial of axillary node dissection in women with clinical T1–2 N0 M0 breast cancer who have a positive sentinel node; ALND = axillary lymph node dissection; ALMANAC = Axillary Lymphatic Mapping Against Nodal Axillary Clearance; AMAROS = After Mapping of the Axilla: Radiotherapy Or Surgery?; GIVOM = Gruppo Interdisciplinare Veneto Oncologia Mammaria; IBCSG 23-01 = International Breast Cancer Study Group randomized trial of axillary dissection vs. no axillary dissection for patients with clinically node negative breast cancer and micrometastases in the sentinel node; NSABP B32 = National Surgical Adjuvant Breast and Bowel Project, Protocol B-32; RT = radiotherapy; SLN = sentinel lymph node; SLNB = sentinel lymph node biopsy.