RISAS Procedure in Node Positive Breast Cancer Following NAC (RISAS)
Primary Purpose
Breast Neoplasm, Neoadjuvant Therapy, Axillary Lymph Nodes
Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
RISAS
Sponsored by
About this trial
This is an interventional diagnostic trial for Breast Neoplasm
Eligibility Criteria
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)
Sites / Locations
- Wilhelmina Hospital
- Amphia Hospital
- Albert Schweitzer Hospital
- Martini Hospital
- Zuyderland Medical Center
- Hospital Group Twente
- Treant
- Maastricht University Medical Center
- Bravis Hospital
- Erasmus Medical Center
- Ikazia Hospital
- Maasstad Hospital
- Franciscus Gasthuis & Vlietland
- University Medical Center Utrecht
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
RISAS
Arm Description
All patients will undergo RISAS procedure, followed by axillary lymph node dissection in a one-step surgical procedure.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT02800317
First Posted
June 7, 2016
Last Updated
February 9, 2022
Sponsor
Erasmus Medical Center
Collaborators
Amphia Hospital, Maastricht University Medical Center, UMC Utrecht
1. Study Identification
Unique Protocol Identification Number
NCT02800317
Brief Title
RISAS Procedure in Node Positive Breast Cancer Following NAC
Acronym
RISAS
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
March 30, 2017 (Actual)
Primary Completion Date
July 1, 2020 (Actual)
Study Completion Date
December 3, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Erasmus Medical Center
Collaborators
Amphia Hospital, Maastricht University Medical Center, UMC Utrecht
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Neoplasm, Neoadjuvant Therapy, Axillary Lymph Nodes, Pathological Complete Response
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
248 (Actual)
8. Arms, Groups, and Interventions
Arm Title
RISAS
Arm Type
Experimental
Arm Description
All patients will undergo RISAS procedure, followed by axillary lymph node dissection in a one-step surgical procedure.
Intervention Type
Procedure
Intervention Name(s)
RISAS
Intervention Description
RISAS procedure contains Radioactive Iodine Seed localisation in the Axilla in axillary node positive breast cancer combined with a Sentinel node procedure.
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
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.
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Linetta B Koppert, MD, PhD
Organizational Affiliation
Erasmus Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ernest JT Luiten, MD, PhD
Organizational Affiliation
Amphia Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Marjolein L Smidt, MD, PhD
Organizational Affiliation
Maastricht University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wilhelmina Hospital
City
Assen
Country
Netherlands
Facility Name
Amphia Hospital
City
Breda
Country
Netherlands
Facility Name
Albert Schweitzer Hospital
City
Dordrecht
Country
Netherlands
Facility Name
Martini Hospital
City
Groningen
Country
Netherlands
Facility Name
Zuyderland Medical Center
City
Heerlen
Country
Netherlands
Facility Name
Hospital Group Twente
City
Hengelo
Country
Netherlands
Facility Name
Treant
City
Hoogeveen
Country
Netherlands
Facility Name
Maastricht University Medical Center
City
Maastricht
Country
Netherlands
Facility Name
Bravis Hospital
City
Roosendaal
Country
Netherlands
Facility Name
Erasmus Medical Center
City
Rotterdam
Country
Netherlands
Facility Name
Ikazia Hospital
City
Rotterdam
Country
Netherlands
Facility Name
Maasstad Hospital
City
Rotterdam
Country
Netherlands
Facility Name
Franciscus Gasthuis & Vlietland
City
Schiedam
Country
Netherlands
Facility Name
University Medical Center Utrecht
City
Utrecht
Country
Netherlands
12. IPD Sharing Statement
Citations:
PubMed Identifier
28487053
Citation
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.
Results Reference
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RISAS Procedure in Node Positive Breast Cancer Following NAC
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