Table 1.
Country/name | Population | Randomization | Endpoint | Size | Start | End | TAXIS overlap | |
---|---|---|---|---|---|---|---|---|
1 | Italy: SOUND IEO S637/311 NCT02167490 | cT1cN0 US negative |
SLN vs. observation | DDFS | 1560 | Jan 2012 | Jan 2017 | No |
2 | Germany: INSEMA NCT02466737 | cT1–2 cN0 US negative |
1. SLN vs. observation 2. 1–2 SLN+ → ALND vs. no ALND |
DFS | 7095 | Sept 2015 | Sept 2024 | No |
3 | France: SERC/IPC 2012–001 DNCT01717131 | cT1–2 cN0 | ALND vs. no ALND | DFS | 3000 | July 2012 | July 2025 | Minimal |
4 | China: Z0011-China NCT01796444 | cT1–2 cN0 1–2SLN+ |
ALND vs. no ALND | DFS | Not shown | Jan 2013 | June 2026 | No |
5 | Sweden: SENOMAC NCT02240472 | cT1–2 cN0 cT1–2 iN1 1–2 SLN+ |
ALND vs. no ALND | BCSS | 3500 | Jan 2015 | Dec 2029 | Minimal |
6 | United Kingdom: POSNOC NCT02401685 | cT1–2 1–2 SLN+ |
ALND or axillary radiotherapy vs. no axillary treatment | Axillary recurrence | 1900 | Jan 2014 | Mar 2023 | No |
7 | Netherlands: BOOG 2013–07 NCT02112682 | cT1–2 cN0 1–3 SLN+ mastectomy |
ALND or axillary radiotherapy vs. no axillary treatment | RRR | 878 | June 2014 | June 2027 | No |
8 | USA: Alliance A011202 NCT01901094 | cT1-3cN1 (S)LN+ after NACT |
ALND+ extended regional nodal irradiation vs. axillary radiotherapy + extended regional nodal irradiation | IBC-RFI | 2918 | Feb 2014 | Jan 2024 | Partial |
ALND axillary lymph node dissection, BCSS, DFS disease-free survival, IBC, NACT, RFI, RRR, SLN sentinel lymph node, US ultrasound