Trial Information

Electrochemotherapy for Chest Wall Recurrence af Breast Cancer: Present Challenges and Future Prospects.

Electrochemotherapy for chest wall recurrence of breast cancer. MD, Ph.D. student, Louise
Wichmann Matthiessen, has been employed in 2008 to perform this study. She plans to complete
her training as specialist in clinical oncology subsequently, and will thus be able to
follow up the work after completion of her Ph.D. The study aims at giving palliation to
patients who are suffering from painful, ulcerated metastases to the chest wall in a
situation where other treatments have failed.

Inclusion criteria: Chest wall recurrence of breast cancer; all other modalities have failed
or patients does not wish to receive them (e.g. chemotherapy); symptomatic relief is needed;
WHO performance status 0-2; normal coagulation parameters, normal kidney and renal function;
written, informed consent. Lesions totalling over 3 cm in diameter. Patient recruitment: 28
patients are to be recruited.

Treatment: Patients will be treated in general anesthesia (inhaling max. 30 % oxygen), and a
standard dose of bleomycin (15.000 IU/ m2) will be given intravenously. Electric pulses will
be administered using a square wave electroporator (IGEA, Carpi, Italy). Needle and plate
electrodes are used in order to treat the affected area efficiently. Eight pulses at a
frequency of 5 kHz will be used for each application of the electrodes. In this way, a large
area can be treated within a short time. Post treatment, the area will be covered by dry
dressings, as are standardly used.

The patients will be seen at 2, 4, and 8 weeks post treatment, and re-treatment can be
administered up to three times in case there are areas which have not been insufficiently
treated in the first round. Lung function will be followed by measurement of DLCO (carbon
monoxide diffusion capacity).

The patients will furthermore be followed up to 1 year after treatment in monthly intervals,
and after 1 year on a yearly basis for up to 5 years.

Evaluation: Evaluation is performed by a) measurement of lesion extension and digital
photography, b) development of a mapping system: Chest wall recurrences are frequently a
confluent mass of tumor with varying depth. Precise mapping of treatment areas and effect is
warranted. To this end, a system combining a fixed point (e.g. small ink tattoo, as used in
radiotherapy planning) with novel imaging techniques using the 3D computer tomography (CT)
planning system employed for radiotherapy, is envisaged. Furthermore, PET-Dual Time Point
scanning combined with CT scanning is being investigated as treatment evaluation.

Safety: Safety will be reported both in terms of evaluation of adverse events and in terms
of patient satisfaction determined by questionnaire, including the 'Derriford Appearance
Questionaire'(18).