Table 9.
Current trials investigating de-escalation of surgical treatment in cN+ patients undergoing neoadjuvant therapy.
| Study | Status | Study Design | Primary Endpoint(s) |
|---|---|---|---|
| ATNEC NCT04109079 | Not yet recruiting | Randomized trial cN+ → ypN0 patients Surgery: TAD Marking technique: clip or carbon suspension Arms: axillary treatment (ALND or ART) vs. no axillary treatment |
DFS Patient-reported lymphedema |
| AXSANA NCT04373655 | Recruiting since June 2020 | Non-interventional cohort study cN+ patients |
iDFS Axillary recurrence rate Quality of life and arm morbidity |
| GANEA 3 NCT03630913 | Recruiting since January 2019 | Single-arm trial cN+ patients (confirmed by biopsy) Surgery: TAD followed by ALND Marking technique: clip, marking of the most suspicious node only |
False-negative rate of SLNB, TLNB, and TAD |
|
MAGELLAN NCT03796559 |
Recruiting | Single-arm trial cN+ patients (confirmed by biopsy) Surgery: TAD Marking technique: clip and magnetic seed |
Retrieval rate of clipped node and magnetic seed |
| Pre-ATNEC NCT03640819 | Completed, results pending | Single-arm trial cN+ patients (confirmed by biopsy) Surgery: TLNB and—at surgeon’s discretion—SLNB or ALND Marking technique: carbon suspension |
Identification rate of marked lymph node(s) |
| RISAS NCT02800317 | Completed, full publication pending [43,53] | Single-arm trial cN+ patients (confirmed by biopsy) Surgery: TAD followed by ALND Marking technique: Radioactive iodine seed |
Identification rate, accuracy, and false negative rate |
| TATTOO DRKS00013169 | Completed, full results pending [47,66] | Single-arm trial cN+ patients (confirmed by biopsy) Surgery: TAD or TLNB + ALND Marking technique: carbon suspension |
Detection rate of the TLN |
|
TAXIS [67] NCT03513614 |
Recruiting | Randomized phase III trial cN+ patients Surgery: tailored axillary surgery with or without ALND followed by radiotherapy |
DFS |
| NCT03718455 | Terminated due to limited operating room availability | Single-arm trial cN+ patients (confirmed by biopsy) Marking technique: Magnetic seed |
Detection rate of the TLN |
| NCT03411070 | Recruiting | Single-arm trial cN+ patients Surgery: Marking technique: radar reflector-localization clip |
Rate of successful removal of the TLN |
Abbreviations: ALND—axillary lymph node dissection, ART—axillary radiation therapy, DFS—disease-free survival, iDFS—invasive disease-free survival, TAD—targeted axillary dissection, TLN—target lymph node.