Proof of pilot studies
Clinical studies with TriMed® of patients with primary breast cancer has taken place at Capio S:t Görans Sjukhus and Danderyds Sjukhus in Stockholm, Sweden.
The first study included 31 women with unifocal primary breast cancer with a tumor diameter up to 16 mm, five patients were excluded because of uncertain electrode placement and tumor sizes larger than revealed on mammography and ultrasound.
All the 26 patients with TriMed® treated tumors had a surgical removal of the lesions performed directly after treatment. All patients showed a complete ablation of the tumor. The resected tissue specimen from each patient was analyzed using conventional histopathological methods in order to determine the size of the lesion and the potential viability of the cancer cells.
The objective of the second study was to assess efficacy and safety of ultrasound guided TriMed® treatment in early breast cancer. 18 patients with tumor size up to 16 mm were TriMed® treated and the lesions were surgically removed three weeks later. Before removal of the lesions Magnetic Resonance Imaging (MRI) was performed. MRI showed no residual tumor growth in 100% of cases. In addition complete tumor devitalization was stated based on viability immune staining.
After the positive result obtained in studies 1 and 2 showing a complete devitalization of the TriMed® treated tumors five patients have been treated without following surgical removal of the treated area. None of these five patients have shown local recurrence according to MRI imaging.
After five years follow up, none of the total 49 patients with early breast cancer treated with TriMed® has developed local recurrences.