Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Amphia Hospital | OTHER |
| Maastricht University Medical Center | OTHER |
| UMC Utrecht | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RISAS | Experimental | All patients will undergo RISAS procedure, followed by axillary lymph node dissection in a one-step surgical procedure. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RISAS | Procedure | RISAS procedure contains Radioactive Iodine Seed localisation in the Axilla in axillary node positive breast cancer combined with a Sentinel node procedure. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wilhelmina Hospital | Assen | Netherlands | ||||
| Amphia Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28487053 | Background | 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. | |
| 39302345 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Breda |
| Netherlands |
| Albert Schweitzer Hospital | Dordrecht | Netherlands |
| Martini Hospital | Groningen | Netherlands |
| Zuyderland Medical Center | Heerlen | Netherlands |
| Hospital Group Twente | Hengelo | Netherlands |
| Treant | Hoogeveen | Netherlands |
| Maastricht University Medical Center | Maastricht | Netherlands |
| Bravis Hospital | Roosendaal | Netherlands |
| Erasmus Medical Center | Rotterdam | Netherlands |
| Ikazia Hospital | Rotterdam | Netherlands |
| Maasstad Hospital | Rotterdam | Netherlands |
| Franciscus Gasthuis & Vlietland | Schiedam | Netherlands |
| University Medical Center Utrecht | Utrecht | Netherlands |
| Derived |
| 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. |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided