Table 1

Trial registration information

Data categoryInformation
Primary registry and trial identifying numberNetherlands Trial Register: NL9205
Date of registration in primary registry20 January 2021
Secondary identifying numbersMedical 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 supportMonetary 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 sponsorFranciscus Gasthuis & Vlietland
Secondary sponsor(s)NA
Contact for public queriesE.M.F. van de Voort, MD, e.voort@franciscus.nl
Contact for scientific queriesE.M.F. van de Voort, MD, e.voort@franciscus.nl
Public titleThe Treatment of Breast Cancer with Percutaneous Thermal Ablation: A phase 2 screening trial
Scientific titleThe Treatment of Breast Cancer with Percutaneous Thermal Ablation: A phase 2 screening trial (THERMAC)
Countries of recruitmentThe Netherlands
Health condition(s) or problem(s) studiedBreast cancer
Intervention(s)Radiofrequency ablation, microwave ablation, cryoablation
Key inclusion and exclusion criteriaAll 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 typeInterventional
Allocation: randomised comparison stratified by tumour size, three arms, open label
Primary purpose: treatment
Phase 2
Date of first enrolmentApril 2021
Sample size63, 21 per arm
Recruitment statusRecruiting
Primary outcomesProportion 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 outcomesCosmetic 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 reviewApproved by the Medical Research Ethics Committee (in Dutch: Medisch Ethische Toetsingscommissie (METC)) Erasmus MC, Rotterdam, the Netherlands