Image-guided Targeted Doxorubicin Delivery With Hyperthermia to Optimize Loco-regional Control in Breast Cancer
Status:
Recruiting
Trial end date:
2022-11-01
Target enrollment:
Participant gender:
Summary
In this phase I feasibility study, the investigators evaluate the combination of
lyso-thermosensitive liposomal doxorubicin (LTLD, ThermoDox) with local hyperthermia and
cyclophosphamide (C), for the local treatment of the primary breast tumour in patients with
metastatic breast cancer.
When heated to 40-43 degrees Celsius (ºC), LTLD releases a very high concentration of
doxorubicin locally within seconds. Hyperthermia of the primary tumour will be induced by
Magnetic Resonance guided High Intensity Focused Ultrasound (MR-HIFU) on a dedicated
Sonalleve MR-HIFU breast system.
The investigators hypothesize that by substituting doxorubicin (A) in the AC-chemotherapy
regimen for the combination of LTLD and MR-HIFU induced hyperthermia, optimal local tumour
control can be achieved without compromising systemic toxicity or efficacy.
This will be the first study to evaluate LTLD with MR-HIFU hyperthermia in breast cancer
patients.
Phase:
Phase 1
Details
Lead Sponsor:
UMC Utrecht
Collaborators:
Center for Translational Molecular Medicine Dutch Cancer Society Vrienden UMC Utrecht