A Study Evaluating INIPARIB in Combination With Chemotherapy to Treat Triple Negative Breast Cancer Brain Metastasis

Inclusion criteria

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• Histologically-confirmed, ER negative, PR negative and Her2 negative adenocarcinoma of the breast with brain lesion on radiographic imaging.
• ECOG Performance Status of 0-2.
• Life expectancy of >12 weeks.
• No limit to prior therapies with last anti-cancer treatment ≥ 2 weeks from initiation of protocol-based therapy provided all toxicities (other than alopecia) have resolved to ≤Grade 1 or baseline.
• No active serious infection or other comorbid illness which would impair ability to participate in the trial.
• Stable or decreasing dose of steroids for ≥ 7 days.
• Interval ≥ 4 weeks between open brain biopsy and initiation of protocol-based therapy.
• Patients must have adequate organ function.

Exclusion criteria

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• Pregnant or breast-feeding
• Prior allergic reaction to INIPARIB
• Prior allergic reaction to irinotecan.
• Evidence of hemorrhage or impending herniation on baseline brain imaging
• Evidence of diffuse leptomeningeal disease on brain MRI or by previously documented CSF cytology-NOTE: discrete dural metastases are permitted.
• Clinically significant cardiac, renal, hepatic, infectious or pulmonary disease which might affect trial participation.
• Concurrent or planned radiation, hormonal, chemotherapeutic, experimental or targeted biologic therapy.
• Contraindication to gadolinium-enhanced MRI imaging.
• Inability to comply with study and/or follow-up procedures.