A Phase II Study of the PARP Inhibitor, INIPARIB (BSI-201), in Combination With Chemotherapy to Treat Triple Negative Breast Cancer Brain Metastasis

Inclusion Criteria

Inclusion Criteria -

1. Histologically-confirmed, ER negative, PR negative and Her2 negative adenocarcinoma
of the breast with brain lesion on radiographic imaging.

2. ECOG Performance Status of 0-2.

3. Life expectancy of >12 weeks.

4. 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.

5. No active serious infection or other comorbid illness which would impair ability to
participate in the trial.

6. Stable or decreasing dose of steroids for ≥ 7 days.

7. Interval ≥ 4 weeks between open brain biopsy and initiation of protocol-based
therapy.

8. Patients must have adequate organ function.

Exclusion Criteria -

1. Pregnant or breast-feeding

2. Prior allergic reaction to INIPARIB

3. Prior allergic reaction to irinotecan.

4. Evidence of hemorrhage or impending herniation on baseline brain imaging

5. Evidence of diffuse leptomeningeal disease on brain MRI or by previously documented
CSF cytology-NOTE: discrete dural metastases are permitted.

6. Clinically significant cardiac, renal, hepatic, infectious or pulmonary disease which
might affect trial participation.

7. Concurrent or planned radiation, hormonal, chemotherapeutic, experimental or targeted
biologic therapy.

8. Contraindication to gadolinium-enhanced MRI imaging.

9. Inability to comply with study and/or follow-up procedures.