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.
Age range
18 Years
Sex
FEMALE
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Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Incidence of adverse events assessed by CTCAE v 5.0
Timeframe: From first study treatment (day 1) until the end of study visit between day 161 and 175
Incidence of dose limiting toxicities
Timeframe: From first study treatment (day 1) until the end of study visit between day 161 and 175
Incidence of necessity for dose adjustments, delay or early cessation
Timeframe: From first study treatment (day 1) until the end of study visit between day 161 and 175
Incidence and severity of post-procedural pain
Timeframe: From first study treatment (day 1) until the end of study visit between day 161 and 175
Patient reported tolerability via an adapted version of the Cancer Therapy Satisfaction Questionnaire (CTSQ)
Timeframe: Baseline, day 49 and day 112
Patient reported tolerability via the Functional Assessment of Cancer Therapy - Breast (FACT-B) questionnaire
Timeframe: Baseline, and on day 14 of each cycle (with a maximum of six 21-day cycles in 18 weeks)
Incidence of cardiotoxity
Timeframe: From first study treatment (day 1) until the end of study visit between day 161 and 175
Description of MR thermometry data (describing the temperatures achieved)
Timeframe: On day 1 (study treatment day) of each cycle (with a maximum of six 21-day cycles in 18 weeks)
Duration of procedures on a treatment day
Timeframe: On day 1 (study treatment day) of each cycle (with a maximum of six 21-day cycles in 18 weeks)
Number of completed cycles with MR-HIFU induced hyperthermia, ThermoDox and cyclophosphamide
Timeframe: From first study treatment (day 1) until the end of study visit between day 161 and 175
The number of cycles in which hyperthermia was sufficient: at least 30 minutes at the target temperature of 40-42°C
Timeframe: From first study treatment (day 1) until the end of study visit between day 161 and 175