RISAS Procedure in Node Positive Breast Cancer Following NAC

Status Not yet recruiting

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.

Clinical Trial Description

n/a

Study Design

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

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02792101
Study type	Interventional
Source	Amphia Hospital
Contact	Thiemo JA van Nijnatten, MD
Phone	0031433881575
Email	Thiemo.nijnatten@mumc.nl
Status	Not yet recruiting
Phase	N/A
Start date	August 2016

View Details

See also
Status	Clinical Trial	Phase
Enrolling by invitation	`NCT05558917` - Comparison Between PECS BLOCK 2 vs ESP BLOCK in Ocnologic Breast Surgery	N/A
Active, not recruiting	`NCT03664778` - Abbreviated Breast MRI After Cancer Treatment
Recruiting	`NCT03144622` - 18F-FSPG PET/CT Imaging in Patients With Cancers
Completed	`NCT05452499` - Pain Neuroscience Education and Therapeutic Exercise as a Treatment for Breast Cancer Survivors Living With Sequelae	N/A
Active, not recruiting	`NCT04568902` - Study of H3B-6545 in Japanese Women With Estrogen Receptor (ER)-Positive, Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Breast Cancer	Phase 1
Completed	`NCT02860585` - Evaluation of Survival in Patients With Metastatic Breast Cancer Receiving High-dose Chemotherapy With Autologous Haematopoietic Stem Cell Transplantation	N/A
Completed	`NCT04059809` - Photobiomodulation for Breast Cancer Radiodermatitis	Phase 2/Phase 3
Recruiting	`NCT04557449` - Study to Test the Safety and Tolerability of PF-07220060 in Participants With Advance Solid Tumors	Phase 1/Phase 2
Completed	`NCT03698942` - Delphinus SoftVue™ ROC Reader Study
Completed	`NCT00092950` - Exercise in Women at Risk for Breast Cancer	Phase 2
Withdrawn	`NCT04123704` - Sitravatinib in Metastatic Breast Cancer	Phase 2
Not yet recruiting	`NCT02151071` - The Breast Surgery EnLight and LightPath Imaging System Study	Phase 1/Phase 2
Recruiting	`NCT02934360` - TR(ACE) Assay Clinical Specimen Study	N/A
Active, not recruiting	`NCT02950064` - A Study to Determine the Safety of BTP-114 for Treatment in Patients With Advanced Solid Tumors With BRCA Mutations	Phase 1
Completed	`NCT02931552` - Nuevo Amanecer II: Translating a Stress Management Program for Latinas	N/A
Not yet recruiting	`NCT02876848` - A Novel E-Health Approach in Optimizing Treatment for Seniors (OPTIMUM Study)	N/A
Recruiting	`NCT02547545` - Breast Cancer Chemotherapy Risk Prediction Mathematical Model	N/A
Completed	`NCT02303366` - Pilot Study of Stereotactic Ablation for Oligometastatic Breast Neoplasia in Combination With the Anti-PD-1 Antibody MK-3475	Phase 1
Completed	`NCT02518477` - Preventive Intervention Against Lymphedema After Breast Cancer Surgery	N/A
Completed	`NCT02652975` - Anticancer Treatment of Breast Cancer Related to Cardiotoxicity and Dysfunctional Endothelium	N/A