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

Conditions: Breast Cancer

Registration Number: NL-OMON26534

Lead Sponsor: Franciscus Gasthuis & Vlietland

Brief Summary: /A

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 63

Inclusion Criteria

1.Woman
2.Age > 45 years and postmenopausal; no menstrual period for at least 12 months.
3.Pathologically confirmed primary invasive breast cancer, unilateral, unifocal
4.A clinical T1N0M0 tumor (= 2cm on US and/or MRI), without distant metastases. The largest dimension measured will be used to determine eligibility.
5.Tumor should be visible on ultrasound.
6.Intraductal component = 25% of the tumor on MRI, complete area including intraductal component should not exceed 2cm.
7.Sufficient knowledge of the Dutch language to complete the 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
The primary outcome is to estimate the success rate in terms of the proportion of complete ablation at pathologic evaluation of the surgical specimen.

Secondary Outcome Measures

Name	Time	Method
Feasibility of the three thermal ablation techniques (RFA, MWA, CA) in an outpatient setting;<br>Predictive value of MRI for complete ablation when the tumor is treated with thermal ablation (RFA, MWA, CA);<br>Patient satisfaction after thermal ablation (RFA, MWA, CA);<br>Adverse events, side effects and cosmetic outcome after thermal ablation (RFA, MWA, CA) with adequate follow-up using validated questionnaires;<br>System usability of each thermal ablation technique (RFA, MWA, CA);<br>The immune response and the degree of this potential immune response after thermal ablation (RFA, MWA, CA).