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RISAS Procedure in Node Positive Breast Cancer Following NAC (RISAS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02800317
Recruitment Status : Active, not recruiting
First Posted : June 15, 2016
Last Update Posted : January 31, 2020
Sponsor:
Collaborators:
Amphia Hospital
Maastricht University Medical Center
UMC Utrecht
Information provided by (Responsible Party):
L.B. Koppert, Erasmus Medical Center

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.


Condition or disease Intervention/treatment Phase
Breast Neoplasm Neoadjuvant Therapy Axillary Lymph Nodes Pathological Complete Response Procedure: RISAS Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 248 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: RISAS
All patients will undergo RISAS procedure, followed by axillary lymph node dissection in a one-step surgical procedure.
Procedure: RISAS
RISAS procedure contains Radioactive Iodine Seed localisation in the Axilla in axillary node positive breast cancer combined with a Sentinel node procedure.




Primary Outcome Measures :
  1. 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 Measures :
  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. [ 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. ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02800317


Locations
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Netherlands
Wilhelmina Hospital
Assen, Netherlands
Amphia Hospital
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
Sponsors and Collaborators
Erasmus Medical Center
Amphia Hospital
Maastricht University Medical Center
UMC Utrecht
Investigators
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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
Publications:
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Responsible Party: L.B. Koppert, MD, PhD, Erasmus Medical Center
ClinicalTrials.gov Identifier: NCT02800317    
Obsolete Identifiers: NCT02792101
Other Study ID Numbers: 2015-8023
First Posted: June 15, 2016    Key Record Dates
Last Update Posted: January 31, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases