RISAS Procedure in Node Positive Breast Cancer Following NAC (RISAS)
|ClinicalTrials.gov Identifier: NCT02800317|
Recruitment Status : Active, not recruiting
First Posted : June 15, 2016
Last Update Posted : January 31, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Breast Neoplasm Neoadjuvant Therapy Axillary Lymph Nodes Pathological Complete Response||Procedure: RISAS||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||248 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||March 30, 2017|
|Estimated Primary Completion Date :||May 2020|
|Estimated Study Completion Date :||July 2020|
All patients will undergo RISAS procedure, followed by axillary lymph node dissection in a one-step surgical procedure.
RISAS procedure contains Radioactive Iodine Seed localisation in the Axilla in axillary node positive breast cancer combined with a Sentinel node procedure.
- 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. ]
- 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. ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02800317
|Albert Schweitzer Hospital|
|Zuyderland Medical Center|
|Hospital Group Twente|
|Maastricht University Medical Center|
|Erasmus Medical Center|
|Franciscus Gasthuis & Vlietland|
|University Medical Center Utrecht|
|Principal Investigator:||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|