BP-C1 in Metastatic Breast Cancer Patients

Exclusion Criteria

• •1. Abnormal liver function classified as total bilirubin \>34 μmol/L or ALAT \> 3 times the upper limit of normal range (ULN). In case of metastases in the liver, the ALAT limit for exclusion is set to 5xULN. Re-test results of blood samples taken again up to 2 days before Day-1 must keep meeting eligibility criteria.
• •2. Abnormal kidney function defined by serum creatinine \>120 μmol/L. Re-test results of blood samples taken again up to 2 days before Day-1 must keep meeting eligibility criteria.
• •3. Abnormal coagulation capacity defined by the relative arbitrary concentration of coagulation factors 2,7,10 INR \>1.3. Re-test results of blood samples taken again up to 2 days before Day-1 must keep meeting eligibility criteria.
• •4. Brain metastases in symptomatic patients requiring ≥4 mg dexamethasone/day. However, patients with treated brain metastases by surgery or radiation who are stable and symptom-free (\<4 mg dexamethasone/day) for a minimum period of 4 weeks prior to study treatment are eligible.
• •5. Synchronous cancer except for non-melanoma skin cancer and early stage of cervical cancer.
• •6. Abnormal haematology status defined by Hb \< 9.0 g/dL, platelet count \< 75,000/mm\^3 and leukocytes \< 3x10\^9/L. Re-test results of blood samples taken again up to 2 days before Day-1 must keep meeting eligibility criteria.
• •7. Clinically significant abnormal ECG.
• •8. Karnofsky Performance Status Score \< 50%.
• •9. Pregnant or breast feeding women.
• •10. Women of fertile age who do not want to be tested for possible pregnancy.
• •11. Fertile female who do not want to use safe protection against pregnancy, starting one month before start of the trial treatment and lasting at least six weeks after.
• •12. Uncontrolled bacterial, viral, fungal or parasite infection.
• •13. Under systemic treatment with corticosteroids or other immunosuppressive drugs during the last 21 days before start of the trial treatment. Systemic treatment with \<4 mg dexamethasone/day is allowed
• •14. Participating in another clinical trial with pharmaceuticals during the last six weeks before start of this trial treatment.
• •15. Not able to understand written or oral information.
• •16. Do not want or is not able to give written consent to participate in the study.