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RISAS Procedure in Node Positive Breast Cancer Following NAC

NCT02800317 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 248

Last updated 2022-02-10

No results posted yet for this study

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.

Conditions

  • Breast Neoplasm
  • Neoadjuvant Therapy
  • Axillary Lymph Nodes
  • Pathological Complete Response

Interventions

PROCEDURE

RISAS

RISAS procedure contains Radioactive Iodine Seed localisation in the Axilla in axillary node positive breast cancer combined with a Sentinel node procedure.

Sponsors & Collaborators

  • Amphia Hospital

    collaborator OTHER

  • Maastricht University Medical Center

    collaborator OTHER

  • UMC Utrecht

    collaborator OTHER

  • Erasmus Medical Center

    lead OTHER

Principal Investigators

  • Linetta B Koppert, MD, PhD · Erasmus Medical Center

  • Ernest JT Luiten, MD, PhD · Amphia Hospital

  • Marjolein L Smidt, MD, PhD · Maastricht University Medical Center

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-30
Primary Completion
2020-07-01
Completion
2021-12-03

Countries

  • Netherlands

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02800317 on ClinicalTrials.gov