Electrochemotherapy For The Treatment Of Breast Cancer That Has Spread to the Skin

Inclusion Criteria:

• Male or female patients > 18 years of age

• Histological confirmed breast cancer

• Metastatic breast cancer (skin lesions only are considered as metastatic disease)

• Prior histological confirmation of at least one skin lesion

• Skin lesions must not have a depth greater than 3 cm (measured clinically if possibleotherwise on the basis of CT/ultrasound examination

• Confluent skin metastases where individual lesions are hard to define in theirentirety may not exceed a maximum area of 10 x 10 cm for each area of confluence. Ifthere are several areas of confluence, the patient may be included in the studyprovided that all lesions can be treated within the time constraints of a single ECTsession (20 minutes).

• Not more than ten skin lesions. Each area of confluence is considered as one lesion.

• A single skin lesion may not exceed 5 cm

• Patients may not have received more than one line of systemic treatment (chemotherapyor endocrine therapy) for metastatic disease following the discovery of skinmetastases. Patients developing skin metastases for the first time during ongoingsystemic therapy may receive one additional line of systemic treatment prior toinclusion.

• Patients in the early ECT arm may receive any other cancer treatments at thediscretion of the treating physician starting no earlier than 2 weeks following ECT.This is to ensure that patients with metastatic disease in other locations willreceive treatment that is considered suitable regardless of their participation inthis trial. (If 2 weeks from ECT to the start of systemic treatment is judged to betoo long by the treating physician, this patient should not be entered into thetrial).

• Women of childbearing age must practice a suitable form of contraception.

• A life expectancy of at least 6 months.

• Patients with a ECOG performance status < 3

• Signed Informed Consent

Exclusion Criteria:

• Patients who have extensive and rapidly progressive visceral metastases where a delayin systemic therapy by eventual ECT is judged to not be in the patients` best interest

• Patients, who for medical reasons, cannot be given bleomycin

• Patients with brain metastases treated with surgery and/or radiotherapy who haveprogressive disease in the brain two months after treatment

• Prior cumulative dose of bleomycin exceeding 250,000 IU/m2

• Less than 14 days from previous cancer treatment (either local or systemic)

• If the patient has skin lesions that are situated in close proximity to a pacemakersuch that an electrical field from ECT will overlap the pacemaker, the pacemaker mustbe moved to another location in order for the patient to be able to participate in thestudy

• Chronic renal failure (serum creatinine > 150 mol/L)

• Inadequate liver function defined as: ASAT or ALAT > 2.5 x ULN in the absence of liver metastases or > 5 in the presence of livermetastases or Bilirubin > 2 x ULN (except in the case of Gilberts Syndrome) or Albumin < 25g/L

• Inadequate bone marrow reserve defined as: White blood cell count < 3 X 109/L orNeutrophil count < 1.5 X109/L or Platelet count < 100 X 109/L

• Any severe uncontrolled systemic disease.

• Unable or unwilling to comply with the study protocol