breast cancer breast neoplasms
Conditions
Interventions
Ultrasound guided percutaneous RFA, MWA or CA will be performed 1-2 weeks after
diagnosis. Surgical resection will take place 3 months after thermal ablation
in all patients. Surgical procedure will
Sponsors
Franciscus Ziekenhuis
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Woman 2. Pathologically confirmed primary invasive breast cancer, unilateral, unifocal 3. A clinical T1N0M0 tumor (
Exclusion criteria
Exclusion criteria: 1. History of invasive breast cancer 2. Pregnant or nursing 3. BRCA 1 or 2 positive 4. Breast augmentation 5. Electrical devices and/or implants 6. Neoadjuvant chemotherapy 7. Triple negative tumors 8. Lobular carcinoma 9. Allergic to local anaesthetics 10. HER2-neu overexpression tumors 11. Bloom-Richardson-Elston (BRE) grade 3 tumors
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of patients in whom complete ablation was achieved by RFA, MWA or CA, based on the histopathology of the resection specimen determined with CK8/18 and H&E staining. | — |
Secondary
| Measure | Time frame |
|---|---|
| • Feasibility of each technique in an outpatient setting, in terms of serious adverse events (SAE), complications, treatment tolerability and system usability. • Predictive value of MRI for complete ablation of the tumor • Patient satisfaction, measured with numeric pain scales, visual analog scale and open questions. • Cosmetic outcome measured with BCTOS-13, Breast-Q and BCCT.core • Degree of immune response of the three techniques: local response measured in tissue, and peripheral response measured in blood samples. | — |
Countries
Netherlands
Outcome results
None listed