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

Inclusion Criteria -

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 -

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.