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

Phase 2
21 Years
Open (Enrolling)
Estrogen Receptor Negative (ER-Negative) Breast Cancer, Progesterone Receptor Negative (PR-Negative) Breast Cancer, Human Epidermal Growth Factor Receptor 2 Negative (HER2-Negative) Breast Cancer, Brain Metastases

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Trial Information

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

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.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:


Outcome Description:

AS measured by intra or extra cranial time to progression (TTP)

Outcome Time Frame:

12 months

Safety Issue:


Principal Investigator

Clinical Sciences & Operations

Investigator Role:

Study Director

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




Start Date:

July 2010

Completion Date:

January 2013

Related Keywords:

  • Estrogen Receptor Negative (ER-Negative) Breast Cancer
  • Progesterone Receptor Negative (PR-Negative) Breast Cancer
  • Human Epidermal Growth Factor Receptor 2 Negative (HER2-Negative) Breast Cancer
  • Brain Metastases
  • Triple negative breast cancer
  • Brain metastasis
  • BSI-201
  • iniparib
  • Breast Neoplasms
  • Neoplasm Metastasis
  • Neoplasms, Second Primary
  • Brain Neoplasms



Johns Hopkins UniversityBaltimore, Maryland  21205
University of MichiganAnn Arbor, Michigan  48109-0624
MD Anderson Cancer CenterHouston, Texas  77030-4096
University of Pittsburgh Medical CenterPittsburgh, Pennsylvania  15213
Duke UniversityDurham, North Carolina  27710
University of Alabama at BirminghamBirmingham, Alabama  35294-3300
Vanderbilt UniversityNashville, Tennessee  37232-6305
Georgetown UniversityWashington, District of Columbia  20007-2197
Dana Farber Cancer InstituteBoston, Massachusetts  02115
University of ChicagoChicago, Illinois  60637
University of California at San FranciscoSan Francisco, California  94115
Indiana University Simon Cancer CenterIndianapolis, Indiana  46202
University of North Carolina-CH Lineberger Comprehensive Cancer CenterChapel Hill, North Carolina  27599-7295