The treatment of breast cancer with thermal ablation: a pilot study

Phase 2

Withdrawn

• Conditions: breast cancer; breast neoplasms; 10006291; 10006232; 10006295

• Registration Number: NL-OMON48001
• Lead Sponsor: Franciscus Ziekenhuis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Withdrawn
• Sex: Not specified
• Target Recruitment: 60

Inclusion Criteria

1. Woman
2. Pathologically confirmed unifocal primary invasive breast cancer, unilateral
3. A clinical T1 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. Aged 18 years or older
6. Component DCIS < 25% on MRI as a total of the tumor
7. Written informed consent

Exclusion Criteria

1. History of invasive breast cancer
2. Pregnant or nursing
3. BRCA 1 or 2 positive (if known)
4. Breast augmentation
5. Electrical devices and/or implants
6. Neoadjuvant chemotherapy
7. Triple negative tumors, Her2neu overexpression, Elston/Nottingham grade 3,
lobular carcinoma
8. Allergic to local anaesthetics

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint in the pilot study is the percentage of tumours with<br /><br>complete ablation on pathology result 2.5 months after TA. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoints are: feasibility of the technique, predictive value of MRI<br /><br>for success of the treatment, the degree and type of immune response, learning<br /><br>curve, system usability radiologist, patient satisfaction, patient reported<br /><br>cosmetic outcome, observed cosmetic result (BCCT.core). </p><br>