Phase 2 Trial of AEZS-108 in Chemotherapy Refractory in Triple Negative Breast Cancer

Exclusion Criteria

• •1. Eastern Cooperative Oncology Group (ECOG) performance status \> 2
• •2. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia or recent myocardial infarction (within 6 months of enrollment)
• •3. Leptomeningeal disease or brain metastases requiring steroids or other therapeutic intervention
• •4. Left ventricular ejection fraction (LVEF) \< 50 %, determined by echocardiogram or MUGA scan
• •5. Compromised organ or marrow function as evidenced by any of the following:
• •* thrombocyte count: \< 100x109/L
• •* absolute neutrophil count (ANC): \< 1.5x109/L
• •* hemoglobin: \< 6.0 mmol/L (\< 9 g/100 mL)
• •* AS(A)T, AL(A)T: \> 2.5 times upper limit of normal range (ULN) (\> 5x ULN if clearly related to liver metastases)
• •* bilirubin: \> 1.5 mg/dL
• •* creatinine: \> 1.5 mg/dL or creatinine clearance \< 40 mL/min.
• •6. Systemic anticancer therapy or radiotherapy within 21 calendar days of the first dose of study drug\*)
• •\* also excluded are patients with anticipated ongoing concomitant anticancer therapy during the study
• •7. Prior exposure to anthracyclines or anthracenediones for the treatment of metastatic breast cancer including liposomal doxorubicin (Doxil), doxorubicin, daunorubicin, or mitoxantrone
• •8. Prior adjuvant anthracyclines with a cumulative anthracycline dose ≥ 300 mg/m2
• •9. Ongoing therapeutic anticoagulation
• •10. Patients who are not surgically sterile or post-menopausal must agree to use for the duration of the study reliable methods of birth control defined as:
• •* complete abstinence
• •* any intrauterine device (IUD) with published data showing that the lowest expected failure rate is \< 1 % per year, or
• •* any other methods with published data showing that the lowest expected failure rate is less than 1 % per year
• •11. Investigational therapy within 30 calendar days of the first scheduled day of protocol treatment (investigational therapy is defined as treatment for which there is currently no regulatory authority approved indication).