Clinical trial NCT02800317: RISAS Procedure in Node Positive Breast Cancer Following NAC
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
Overall status: COMPLETED
Phase: NA
Conditions: Breast Neoplasm
Neoadjuvant Therapy
Axillary Lymph Nodes
Pathological Complete Response
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
Collaborators: name: Amphia Hospital
name: Maastricht University Medical Center
name: UMC Utrecht
First posted: 2016-06-15
Enrollment: 248
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


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)

Primary outcomes:
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.
timeFrame: 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:
measure: 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.
timeFrame: Participants will be followed from the moment of first out-hospital clinic visit untill final breast surgery, an expected average of 4 months.
Other outcomes:
Locations:
city: Assen
country: Netherlands
facility: Wilhelmina Hospital
city: Breda
country: Netherlands
facility: Amphia Hospital
city: Dordrecht
country: Netherlands
facility: Albert Schweitzer Hospital
city: Groningen
country: Netherlands
facility: Martini Hospital
city: Heerlen
country: Netherlands
facility: Zuyderland Medical Center
city: Hengelo
country: Netherlands
facility: Hospital Group Twente
city: Hoogeveen
country: Netherlands
facility: Treant
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Center
city: Roosendaal
country: Netherlands
facility: Bravis Hospital
city: Rotterdam
country: Netherlands
facility: Erasmus Medical Center
city: Rotterdam
country: Netherlands
facility: Ikazia Hospital
city: Rotterdam
country: Netherlands
facility: Maasstad Hospital
city: Schiedam
country: Netherlands
facility: Franciscus Gasthuis & Vlietland
city: Utrecht
country: Netherlands
facility: University Medical Center Utrecht
Study officials:
affiliation: Erasmus Medical Center
name: Linetta B Koppert, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Amphia Hospital
name: Ernest JT Luiten, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Maastricht University Medical Center
name: Marjolein L Smidt, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.