The Treatment of Breast Cancer with PercutaneousThermal Ablation: A phase 2 screening trial

Phase 2

Recruiting

Conditions: breast cancer
breast neoplasms
10006291
10006232
10006295

Registration Number: NL-OMON49602

Lead Sponsor: Franciscus Ziekenhuis

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 63

Inclusion Criteria

1. Woman
2. Pathologically confirmed primary invasive breast cancer, unilateral, unifocal
3. A clinical T1N0M0 tumor (<2cm on US and/or MRI), without distant metastases.
The largest dimension measured will be used to determine eligibility.
4. Tumor should be visible on ultrasound.
5. Postmenopausal; no menstrual period for at least 12 months.
6. Component DCIS < 25% of the tumor on MRI, complete area including DCIS
component should not exceed 2cm.
7. The patient must have sufficient command of the Dutch language to
complete Dutch questionnaires
8. Written informed consent

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The proportion of patients in whom complete ablation was achieved by RFA, MWA<br /><br>or CA, based on the histopathology of the resection specimen determined with<br /><br>CK8/18 and H&E staining. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>• Feasibility of each technique in an outpatient setting, in terms of serious<br /><br>adverse events (SAE), complications, treatment tolerability and system<br /><br>usability.<br /><br>• Predictive value of MRI for complete ablation of the tumor<br /><br>• Patient satisfaction, measured with numeric pain scales, visual analog scale<br /><br>and open questions.<br /><br>• Cosmetic outcome measured with BCTOS-13, Breast-Q and BCCT.core<br /><br>• Degree of immune response of the three techniques: local response measured in<br /><br>tissue, and peripheral response measured in blood samples. </p><br>