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OpenTrials
Completed

NCT Number: NCT02800317

RISAS Procedure in Node Positive Breast Cancer Following NAC

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.

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Key information

Conditions

Breast Neoplasm Axillary Lymph Nodes Breast Diseases Breast Neoplasms Neoadjuvant Therapy Neoplasms Neoplasms by Site Pathological Complete Response Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Wilhelmina Hospital, Assen, Netherlands

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

RISAS

Procedure

RISAS procedure contains Radioactive Iodine Seed localisation in the Axilla in axillary node positive breast cancer combined with a Sentinel node procedure.

Primary outcomes

  1. 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.

    Time frame: Participants will be followed from the moment of first out-hospital clinic visit untill final breast surgery, an expected average of 4 months.

Secondary outcomes

  1. 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.

    Time frame: Participants will be followed from the moment of first out-hospital clinic visit untill final breast surgery, an expected average of 4 months.

Sponsors and collaborators

Lead sponsor

Erasmus Medical Center

Other

Collaborators

  • Amphia Hospital
  • Maastricht University Medical Center
  • UMC Utrecht

Registry information

Official study title

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

Acronym: RISAS

Important dates

Study start
2017
Primary completion
2020
Study completion
2021
First posted
Jun 15, 2016
Registry last updated
Feb 10, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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