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
NCT07546695 · Phase II · Basel, Switzerland
- Condition
- Breast Cancer
- Disease stage
- Stage I-IV
- Phase
- Phase II
- Study type
- OTHER
- Intervention
- Data Collection from medical records of from an already existing database "ONCOLOGICAL BREAST SURGERY DATABASE OF THE UNIVERSITY HOSPITAL OF BASEL" which was initiated in 2016.
- Age
- 18 Years and older
- Gender
- All
- Sponsor
- University Hospital, Basel, Switzerland
- Research institution
- University Hospital, Basel, Switzerland
- Facility
- Department Breast, Abdomen, Pelvis; Universitätsspital Basel
- Research center
- Department Breast, Abdomen, Pelvis; Universitätsspital Basel
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.
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)
Primary outcomes
3-year rate of any axillary recurrence