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

"AEZS-108 (267 mg/m2, 2-hour IV infusion every Day 1 of a 21-day (3-week) cycle. Allowed delay of re-treatment: up to 2 weeks.~Dose reduction: to 210 mg/m2 and 160 mg/m2, if dose limiting toxicity."

"commercially available SSCC (doses below the recommended package insert at the discretion of treating oncologist), on a 21-day cycle (although weekly administration is allowed; note: pegylated liposomal doxorubicin will be administered on a 28-day cycle).~Drugs considered acceptable as SSCC: paclitaxel; nab-paclitaxel; eribulin; pegylated liposomal doxorubicin (PLD); vinorelbine; gemcitabine; capecitabine.~Related to PLD: Per notification from EMA (dated 22-Nov-2011) no new patients should be started on treatment with Caelyx until further notice. Accordingly, this drug may be selected as SSCC treatment option only after such written notice is available."

Recommended prophylactic anti-emetic for AEZS-108: 8 mg dexamethasone.