RISAS Procedure in Node Positive Breast Cancer Following NAC

Last updated: February 9, 2022
Sponsor: Erasmus Medical Center
Overall Status: Completed

Phase

N/A

Condition

Breast Cancer

Treatment

N/A

Clinical Study ID

NCT02800317
2015-8023
  • Ages > 18
  • Female

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Female patient with pathologically confirmed axillary lymph node positive invasiveprimary breast cancer, treated with neoadjuvant chemotherapy
  • Willing and able to undergo all study procedures.
  • Has personally provided written informed consent.

Exclusion

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, treatedwithout any furter surgical procedures)

Study Design

Total Participants: 248
Study Start date:
March 30, 2017
Estimated Completion Date:
December 03, 2021

Connect with a study center

  • Wilhelmina Hospital

    Assen,
    Netherlands

    Site Not Available

  • Amphia Hospital

    Breda,
    Netherlands

    Site Not Available

  • Albert Schweitzer Hospital

    Dordrecht,
    Netherlands

    Site Not Available

  • Martini Hospital

    Groningen,
    Netherlands

    Site Not Available

  • Zuyderland Medical Center

    Heerlen,
    Netherlands

    Site Not Available

  • Hospital Group Twente

    Hengelo,
    Netherlands

    Site Not Available

  • Treant

    Hoogeveen,
    Netherlands

    Site Not Available

  • Maastricht University Medical Center

    Maastricht,
    Netherlands

    Site Not Available

  • Bravis Hospital

    Roosendaal,
    Netherlands

    Site Not Available

  • Erasmus Medical Center

    Rotterdam,
    Netherlands

    Site Not Available

  • Ikazia Hospital

    Rotterdam,
    Netherlands

    Site Not Available

  • Maasstad Hospital

    Rotterdam,
    Netherlands

    Site Not Available

  • Franciscus Gasthuis & Vlietland

    Schiedam,
    Netherlands

    Site Not Available

  • University Medical Center Utrecht

    Utrecht,
    Netherlands

    Site Not Available

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