NCT02800317

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
248

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

14 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 7, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 15, 2016

Completed
10 months until next milestone

Study Start

First participant enrolled

March 30, 2017

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2020

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 3, 2021

Completed
Last Updated

February 10, 2022

Status Verified

February 1, 2022

Enrollment Period

3.3 years

First QC Date

June 7, 2016

Last Update Submit

February 9, 2022

Conditions

Breast NeoplasmNeoadjuvant TherapyAxillary Lymph NodesPathological Complete Response

Outcome Measures

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.

    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.

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

Study Arms (1)

RISAS

EXPERIMENTAL

All patients will undergo RISAS procedure, followed by axillary lymph node dissection in a one-step surgical procedure.

Procedure: RISAS

Interventions

RISASPROCEDURE

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

RISAS

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Wilhelmina Hospital

Assen, Netherlands

Location

Amphia Hospital

Breda, Netherlands

Location

Albert Schweitzer Hospital

Dordrecht, Netherlands

Location

Martini Hospital

Groningen, Netherlands

Location

Zuyderland Medical Center

Heerlen, Netherlands

Location

Hospital Group Twente

Hengelo, Netherlands

Location

Treant

Hoogeveen, Netherlands

Location

Maastricht University Medical Center

Maastricht, Netherlands

Location

Bravis Hospital

Roosendaal, Netherlands

Location

Erasmus Medical Center

Rotterdam, Netherlands

Location

Ikazia Hospital

Rotterdam, Netherlands

Location

Maasstad Hospital

Rotterdam, Netherlands

Location

Franciscus Gasthuis & Vlietland

Schiedam, Netherlands

Location

University Medical Center Utrecht

Utrecht, Netherlands

Location

Related Publications (2)

  • van Nijnatten TJA, Simons JM, Smidt ML, van der Pol CC, van Diest PJ, Jager A, van Klaveren D, Kam BLR, Lobbes MBI, de Boer M, Verhoef K, Koppert LB, Luiten EJT. A Novel Less-invasive Approach for Axillary Staging After Neoadjuvant Chemotherapy in Patients With Axillary Node-positive Breast Cancer by Combining Radioactive Iodine Seed Localization in the Axilla With the Sentinel Node Procedure (RISAS): A Dutch Prospective Multicenter Validation Study. Clin Breast Cancer. 2017 Aug;17(5):399-402. doi: 10.1016/j.clbc.2017.04.006. Epub 2017 Apr 19.

    PMID: 28487053BACKGROUND

  • van Amstel FJG, de Mooij CM, Simons JM, Mitea C, van Diest PJ, Nelemans PJ, van der Pol CC, Luiten EJT, Koppert LB, Smidt ML, van Nijnatten TJA; REFINE Study Group. Disease extent according to baseline [18F]fluorodeoxyglucose PET/CT and molecular subtype: prediction of axillary treatment response after neoadjuvant systemic therapy for breast cancer. Br J Surg. 2024 Aug 30;111(9):znae203. doi: 10.1093/bjs/znae203.

    PMID: 39302345DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

June 7, 2016

First Posted

June 15, 2016

Study Start

March 30, 2017

Primary Completion

July 1, 2020

Study Completion

December 3, 2021

Last Updated

February 10, 2022

Record last verified: 2022-02

Locations

NL(14)