Role of Axillary Lymph Node Dissection for Residual MACROMETASTASES After NEOADJUVANT Chem
In this multicenter retrospective cohort study the aim is to determine the safety of omission of axillary lymph node dissection in patients with TNBC and HER2+ tumors with residual macrometastases (in the SLN/TAD/TAS or MARI node) after NAC.
| Condition(s) | Breast Cancer |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| Summary | In this multicenter retrospective cohort study the aim is to determine the safety of omission of axillary lymph node dissection in patients with TNBC and HER2+ tumors with residual macrometastases (in the SLN/TAD/TAS or MARI node) after NAC. |
| Who can participate | Inclusion Criteria: * Women and men with a diagnosis of stage I-III TNBC or HER2+ breast cancer at diagnosis. HER2+ is defined as an Immunohistochemistry (IHC) score of 3+ or positive FISH. TNBC is defined as ER and Progesterone Receptor (PR) IHC expression of 0 and HER2 negativity defined as either IHC expression of 0-1+ or lack of gene amplification (FISH \< 2.0). Patients with ER low (1-10%) and/or PR low (1-10%) tumors are allowed. * Any histological subtype * For Clinical Nodal Stage (cN) 0 at presentation: any axillary staging technique including palpation with or without imaging is allowed. Dual tracer mapping is not required for SLN surgery. * For cN+ at presentation: Percutaneous biopsy proven confirmation is required at diagnosis. Staging techniques after NAC include: SLN surgery |
| Sex | All |
| Lead sponsor | University Hospital, Basel, Switzerland |
| Locations | Basel, Switzerland |
| Start date | 2026-02-01 |
| NCT ID | NCT07546695 |
| Official listing | https://clinicaltrials.gov/study/NCT07546695 |