RISAS Procedure in Node Positive Breast Cancer Following NAC

Study Overview
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Brief Summary
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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.

Official Title
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Primary Radioactive Iodine Seed Localisation in the Axilla in Axillary Node Positive Breast Cancer Combined With Sentinel Node Procedure (RISAS) Following Neoadjuvant Chemotherapy

Conditions
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Breast Neoplasm, Neoadjuvant Therapy, Axillary Lymph Nodes, Pathological Complete Response

Intervention / Treatment
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* Procedure: RISAS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female patient with pathologically confirmed axillary lymph node positive invasive primary breast cancer, treated with neoadjuvant chemotherapy Willing and able to undergo all study procedures. Has personally provided written informed consent. Exclusion Criteria: Age < 18 Pregnancy or lactation Contra indications for undergoing iodine seed placement or sentinel lymph node biopsy, such as allergic reaction on iodine, 99m Technetium or patent blue. Recurrent breast cancer Previous axillary surgery or radiotherapy Patients with periclavicular lymph node metastases (cN3) Patients with advanced breast cancer (i.e. patients with distant metastases, treated without any furter surgical procedures)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RISAS<br>All patients will undergo RISAS procedure, followed by axillary lymph node dissection in a one-step surgical procedure. | Procedure: RISAS<br>* RISAS procedure contains Radioactive Iodine Seed localisation in the Axilla in axillary node positive breast cancer combined with a Sentinel node procedure.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identification rate and accuracy (sensitivity, negative predictive value (NPV) and false negative rate (FNR)) of RISAS-procedure for identifying axillary pCR, with 95% confidence intervals will be calculated. |  | Participants will be followed from the moment of first out-hospital clinic visit untill final breast surgery, an expected average of 4 months. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The identification rate and accuracy (sensitivity, NPV and FNR) of both techniques used in RISAS-procedure (i.e. SLNB and MARI) for identifying axillary pCR, will be calculated separately as well. |  | Participants will be followed from the moment of first out-hospital clinic visit untill final breast surgery, an expected average of 4 months. |