RISAS Procedure in Node Positive Breast Cancer Following NAC (RISAS)

February 9, 2022 updated by: L.B. Koppert, Erasmus Medical Center

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

248

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Assen, Netherlands
        • Wilhelmina hospital
      • Breda, Netherlands
        • Amphia Hospital
      • Dordrecht, Netherlands
        • Albert Schweitzer Hospital
      • Groningen, Netherlands
        • Martini Hospital
      • Heerlen, Netherlands
        • Zuyderland Medical Center
      • Hengelo, Netherlands
        • Hospital Group Twente
      • Hoogeveen, Netherlands
        • Treant
      • Maastricht, Netherlands
        • Maastricht University Medical Center
      • Roosendaal, Netherlands
        • Bravis Hospital
      • Rotterdam, Netherlands
        • Erasmus Medical Center
      • Rotterdam, Netherlands
        • Maasstad Hospital
      • Rotterdam, Netherlands
        • Ikazia Hospital
      • Schiedam, Netherlands
        • Franciscus Gasthuis & Vlietland
      • Utrecht, Netherlands
        • University Medical Center Utrecht

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Erasmus Medical Center

Collaborators

Maastricht University Medical Center
UMC Utrecht
Amphia Hospital

Investigators

  • Principal Investigator: Linetta B Koppert, MD, PhD, Erasmus Medical Center
  • Principal Investigator: Ernest JT Luiten, MD, PhD, Amphia Hospital
  • Principal Investigator: Marjolein L Smidt, MD, PhD, Maastricht University Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 30, 2017

Primary Completion (Actual)

July 1, 2020

Study Completion (Actual)

December 3, 2021

Study Registration Dates

First Submitted

June 7, 2016

First Submitted That Met QC Criteria

June 10, 2016

First Posted (Estimate)

June 15, 2016

Study Record Updates

Last Update Posted (Actual)

February 10, 2022

Last Update Submitted That Met QC Criteria

February 9, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015-8023

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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