Role of removing axillary nodes after chemotherapy in certain breast cancers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter retrospective study uses data from Basel’s oncologic breast surgery database to see if omitting axillary lymph node dissection after neoadjuvant chemotherapy is safe for patients with HER2-positive or triple-negative breast cancer who still have macrometastases. It includes adults with stage I–III disease and analyzes outcomes from existing medical records. The analysis will focus on surgical extent after response to chemotherapy and may inform future guidelines for axillary management in this setting.

Why it matters

Who can join: the full rules

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)

Where it's running

• Department Breast, Abdomen, Pelvis; Universitätsspital Basel
  Basel, Switzerland Recruiting

Study contacts

• Principal investigator: Walter P. Weber, Prof. Dr. med. — Department Breast, Abdomen, Pelvis
• Study coordinator: Walter P. Weber, Prof. Dr. med.
• Email: walter.weber@usb.ch
• Phone: +41 61 328 61 49

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.