Role of Axillary Lymph Node Dissection for Residual MACROMETASTASES After NEOADJUVANT Chemotherapy in Patients With HER2+ and Triple Negative Breast Cancer: The OPBC-11/MACRONAC Study

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 with dual mapping or Targeted Axillary Dissection (TAD: imaging-guided localization of sampled node in combination with SLN procedure with or without dual mapping) or Tailored Axillary Surgery (TAS: removal of the sentinel lymph nodes as well as selective removal of all palpable disease and documentation of the removal of the initially biopsy-proven and clipped lymph node metastasis by specimen radiography) or the MARI procedure (Marking Axillary Lymph Nodes with Iodine Seeds).
• Received neoadjuvant chemotherapy
• Residual macrometastases (metastasis greater than 2 mm in diameter) detected on SLN surgery or TAD ot TAS or MARI (on frozen section or final pathology)
• Concomitant presence of Isolated Tumor Cells (ITCs) and micrometastases in other sentinel lymph nodes is allowed
• Following SLN surgery/TAD/TAS/MARI patients underwent completion ALND, nodal radiation therapy (RT), both or no further axillary treatment
• At least 1-year follow-up (had surgery at any time point until October 2024 at the latest) - Prior history of ductal carcinoma in situ (DCIS) is allowed

Exclusion criteria

• Did not undergo SLN surgery/TAD/TAS/MARI (e.g., went straight to ALND)
• Presence of ITCs or micrometastases alone in the sentinel nodes (or TAD nodes or MARI node or TAS nodes) without macrometastases
• HR+HER2- tumors (except ER low and or PR-low)
• Stage IV disease at presentation
• Inflammatory breast cancer at presentation
• Neoadjuvant endocrine therapy
• Macrometastases detected by Oncoplastic Breast Consortium (OSNA)