RISAS Procedure in Node Positive Breast Cancer Following NAC

Breast Neoplasms Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02792101
• Other study ID #: 2015-8023
• Status: Not yet recruiting
• Phase: N/A
• First received: June 2, 2016
• Last updated: June 6, 2016
• Start date: August 2016

Study information

• Verified date: June 2016
• Source: Amphia Hospital
• Contact: Thiemo JA van Nijnatten, MD
• Phone: 0031433881575
• Email: Thiemo.nijnatten[@]mumc.nl
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. primary completion date: August 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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)

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
Netherlands	Amphia Hospital	Breda
Netherlands	Maastricht University Medical Center	Maastricht
Netherlands	Erasmus Medical Center	Rotterdam
Netherlands	University Medical Center Utrecht	Utrecht

Sponsors (4)

Lead Sponsor	Collaborator
Amphia Hospital	Erasmus Medical Center, Maastricht University Medical Center, UMC Utrecht

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Identification rate and accuracy (sensitivity, negative predictive value and false negative rate) of RISAS-procedure for identifying axillary pCR, with 95% confidence intervals will be calculated.		Baseline	No
Secondary	The identification rate and accuracy (sensitivity, NPV and FNR) of both techniques used in RISAS-procedure (i.e. sentinel lymph node biopsy and MARI-procedure) for identifying axillary pCR, will be calculated separately as well.		Baseline	No