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RISAS Procedure in Node Positive Breast Cancer Following NAC

Sponsor
Erasmus Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT02800317
Collaborator
Amphia Hospital (Other), Maastricht University Medical Center (Other), UMC Utrecht (Other)
248
Enrollment
14
Locations
1
Arm
56.1
Actual Duration (Months)
17.7
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: RISAS
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
248 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
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
Actual Study Start Date :
Mar 30, 2017
Actual Primary Completion Date :
Jul 1, 2020
Actual Study Completion Date :
Dec 3, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  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. [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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Wilhelmina Hospital Assen Netherlands
2 Amphia Hospital Breda Netherlands
3 Albert Schweitzer Hospital Dordrecht Netherlands
4 Martini Hospital Groningen Netherlands
5 Zuyderland Medical Center Heerlen Netherlands
6 Hospital Group Twente Hengelo Netherlands
7 Treant Hoogeveen Netherlands
8 Maastricht University Medical Center Maastricht Netherlands
9 Bravis Hospital Roosendaal Netherlands
10 Erasmus Medical Center Rotterdam Netherlands
11 Ikazia Hospital Rotterdam Netherlands
12 Maasstad Hospital Rotterdam Netherlands
13 Franciscus Gasthuis & Vlietland Schiedam Netherlands
14 University Medical Center Utrecht Utrecht Netherlands

Sponsors and Collaborators

  • Erasmus Medical Center
  • Amphia Hospital
  • Maastricht University Medical Center
  • UMC Utrecht

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
L.B. Koppert, MD, PhD, Erasmus Medical Center
ClinicalTrials.gov Identifier:
NCT02800317
Other Study ID Numbers:
  • 2015-8023
  • NCT02792101
First Posted:
Jun 15, 2016
Last Update Posted:
Feb 10, 2022
Last Verified:
Feb 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Breast Neoplasms

Study Results

No Results Posted as of Feb 10, 2022