Breast NeoplasmRISASNCT02800317
RISAS Procedure in Node Positive Breast Cancer Following NAC
A study testing RISAS in people with Breast Neoplasm and Neoadjuvant Therapy, run by Erasmus Medical Center at 14 sites in Netherlands.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Neoplasm, Neoadjuvant Therapy, Axillary Lymph Nodes
- What is being tested?
- RISAS
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 248 participants
- Where
- 14 sitesNetherlands
- Study dates
- 30 Mar 2017to 3 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
Netherlands14 sites
Wilhelmina Hospital
Assen
Amphia Hospital
Breda
Albert Schweitzer Hospital
Dordrecht
Martini Hospital
Groningen
Zuyderland Medical Center
Heerlen
Hospital Group Twente
Hengelo
Treant
Hoogeveen
Maastricht University Medical Center
Maastricht
Bravis Hospital
Roosendaal
Erasmus Medical Center
Rotterdam
Ikazia Hospital
Rotterdam
Maasstad Hospital
Rotterdam
Franciscus Gasthuis & Vlietland
Schiedam
University Medical Center Utrecht
Utrecht
About this study
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
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.
- Conditions
- Breast Neoplasm, Neoadjuvant Therapy, Axillary Lymph Nodes, Pathological Complete Response
- Being tested
- RISAS
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RISASProcedure or surgery
RISAS procedure contains Radioactive Iodine Seed localisation in the Axilla in axillary node positive breast cancer combined with a Sentinel node procedure.
| Study group | Role | What they receive |
|---|---|---|
| RISAS | Experimental | All patients will undergo RISAS procedure, followed by axillary lymph node dissection in a one-step surgical procedure. Receives: Procedure: RISAS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Participants will be followed from the moment of first out-hospital clinic visit untill final breast surgery, an expected average of 4 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2016 (estimated)
- Study start30 Mar 2017
- Primary completion1 Jul 2020
- Study completion3 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Breast NeoplasmStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 248 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Amphia Hospital, Maastricht University Medical Center, UMC Utrecht
- Responsible party
- Principal investigator, L.B. Koppert, Erasmus Medical Center
- Investigators
- Linetta B Koppert, MD, PhD, Principal investigator, Erasmus Medical CenterErnest JT Luiten, MD, PhD, Principal investigator, Amphia HospitalMarjolein L Smidt, MD, PhD, Principal investigator, Maastricht University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02800317
- Sponsor's protocol ID
- 2015-8023
- Acronym
- RISAS
- Status last verified
- Feb 2022
- First submitted
- 7 Jun 2016
- Last updated
- 10 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 28487053van 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.
PubMed 39302345
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02800317
- Acronym / sponsor ID
- RISAS / 2015-8023
- Conditions
- Breast Neoplasm, Neoadjuvant Therapy, Axillary Lymph Nodes, Pathological Complete Response
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 248 participants (actual)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Collaborators
- Amphia Hospital, Maastricht University Medical Center, UMC Utrecht
- Study start
- 30 Mar 2017 (actual)
- Primary completion
- 1 Jul 2020 (actual)
- Study completion
- 3 Dec 2021 (actual)
- First posted
- 15 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RISAS | Experimental | Procedure: RISASAll patients will undergo RISAS procedure, followed by axillary lymph node dissection in a one-step surgical procedure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RISASRISAS procedure contains Radioactive Iodine Seed localisation in the Axilla in axillary node positive breast cancer combined with a Sentinel node procedure. | Procedure or surgery | RISAS |
Primary outcome
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.
1 secondary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2022.
- Background: PubMed 28487053van 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.
- Derived from this study: PubMed 39302345van 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Linetta B Koppert, MD, PhD principal investigator
Erasmus Medical Center
Ernest JT Luiten, MD, PhD principal investigator
Amphia Hospital
Marjolein L Smidt, MD, PhD principal investigator
Maastricht University Medical Center
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RISAS in people with Breast Neoplasm and Neoadjuvant Therapy, run by Erasmus Medical Center at 14 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02800317, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2022.