RISAS Procedure in Node Positive Breast Cancer Following NAC

NCT ID: NCT02800317

Last Updated: 2022-02-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 248 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-30
• Study Completion Date: 2021-12-03

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

RISAS

All patients will undergo RISAS procedure, followed by axillary lymph node dissection in a one-step surgical procedure.

Group Type: EXPERIMENTAL

RISAS

Intervention Type: PROCEDURE

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

Interventions

RISAS

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

Intervention Type: PROCEDURE

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Amphia Hospital

OTHER

Sponsor Role: collaborator

Maastricht University Medical Center

OTHER

Sponsor Role: collaborator

UMC Utrecht

OTHER

Sponsor Role: collaborator

Erasmus Medical Center

OTHER

Sponsor Role: lead

Responsible Party

L.B. Koppert

MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Linetta B Koppert, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Erasmus Medical Center

Ernest JT Luiten, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Amphia Hospital

Marjolein L Smidt, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Maastricht University Medical Center

Locations

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

Countries

Netherlands

References

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.

Reference Type: BACKGROUND

PMID: 28487053 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 39302345 (View on PubMed)

Other Identifiers

2015-8023

Identifier Type: -

Identifier Source: org_study_id

NCT02792101

Identifier Type: -

Identifier Source: nct_alias