Primary registry and trial identifying number | Netherlands Trial Register: NL9205 |
Date of registration in primary registry | 20 January 2021 |
Secondary identifying numbers | Medical Research Ethics Committee: MEC-2020-0577; The Central Committee on Research Involving Human Subjects: NL72970.078.20; Franciscus Gasthuis & Vlietland (CastorSMS): 2020-115 |
Sources of monetary and material support | Monetary support: Stichting BOF (Foundation for the promotion of research Franciscus); Team Westland; Stichting Coolsingel (Coolsingel Foundation); Stichting Vrienden van het Havenziekenhuis (Friends of the Havenziekenhuis Foundation); Maurits en Anna de Kock Stichting (Maurits and Anna de Kock Foundation); Material support: IceCure; AngioCare |
Primary sponsor | Franciscus Gasthuis & Vlietland |
Secondary sponsor(s) | NA |
Contact for public queries | E.M.F. van de Voort, MD, e.voort@franciscus.nl |
Contact for scientific queries | E.M.F. van de Voort, MD, e.voort@franciscus.nl |
Public title | The Treatment of Breast Cancer with Percutaneous Thermal Ablation: A phase 2 screening trial |
Scientific title | The Treatment of Breast Cancer with Percutaneous Thermal Ablation: A phase 2 screening trial (THERMAC) |
Countries of recruitment | The Netherlands |
Health condition(s) or problem(s) studied | Breast cancer |
Intervention(s) | Radiofrequency ablation, microwave ablation, cryoablation |
Key inclusion and exclusion criteria | All postmenopausal women with cT1N0M0 breast cancer |
Key inclusion criteria: BRE grade 1 and 2, unilateral and unifocal, tumour should be visible on ultrasound, intraductal component ≤25% of the total tumour |
Key exclusion criteria: Her2neu overexpression, genetic disposition for breast cancer, electrical devices or implants, triple negative tumours, lobular tumours, indication for neoadjuvant chemotherapy, history of breast cancer, allergy to local anaesthetics |
Study type | Interventional |
Allocation: randomised comparison stratified by tumour size, three arms, open label |
Primary purpose: treatment |
Phase 2 |
Date of first enrolment | April 2021 |
Sample size | 63, 21 per arm |
Recruitment status | Recruiting |
Primary outcomes | Proportion of patients in which complete ablation of the tumour was seen at pathologic evaluation of the surgical specimen with CK8/18 and H&E staining (3 months after thermal ablation). |
Key secondary outcomes | Cosmetic outcome on BCTOS-13, Breast-Q and the BCCT.core; Feasibility in an outpatient setting; Patient satisfaction; Adverse events; System usability of the devices; Immune response after thermal ablation |
Ethics review | Approved by the Medical Research Ethics Committee (in Dutch: Medisch Ethische Toetsingscommissie (METC)) Erasmus MC, Rotterdam, the Netherlands |