Breast Neoplasms Clinical Trial
Official title:
Primary Radioactive Iodine Seed Localisation in the Axilla in Axillary Node Positive Breast Cancer Combined With Sentinel Node Procedure (RISAS) Following Neoadjuvant Chemotherapy
Chemotherapy in clinically node positive breast cancer patients is increasingly
administrated in a neoadjuvant setting. The standard treatment regimen in these cases is
then: neoadjuvant chemotherapy (NAC) followed by breast surgery and an axillary lymph node
dissection (ALND). NAC results in axillary pathologic complete response (pCR) in 1 out of 3
patients, indicating a complete absence of axillary metastases after completion of NAC. In
such events, ALND can be regarded as overtreatment that creates unnecessary morbidity. Less
invasive axillary surgery which can accurately assess axillary pCR is therefore preferred
over standard ALND in all patients. In case of detection of remaining axillary lymph node
metastases by this less invasive axillary surgical procedure, completion axillary treatment
is standard of care.
The novel RISAS procedure is introduced as a possible less invasive axillary staging
procedure. RISAS procedure contains Radioactive Iodine Seed localisation in the Axilla in
axillary node positive breast cancer combined with a Sentinel node procedure. The iodine
seed in the axillary lymph node metastasis will be placed prior to start of NAC.
n/a
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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