Status:
COMPLETED
A Study Evaluating INIPARIB in Combination With Chemotherapy to Treat Triple Negative Breast Cancer Brain Metastasis
Lead Sponsor:
Sanofi
Collaborating Sponsors:
UNC Lineberger Comprehensive Cancer Center
Conditions:
Estrogen Receptor Negative (ER-Negative) Breast Cancer
Progesterone Receptor Negative (PR-Negative) Breast Cancer
Eligibility:
All Genders
21+ years
Phase:
PHASE2
Brief Summary
The purpose of the study is to investigate the response rate for triple negative breast cancer patients with brain metastasis when INIPARIB is used in combination with irinotecan. Based on data gener...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2013
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT01173497
Start Date
July 1 2010
End Date
July 1 2013
Last Update
March 17 2016
Active Locations (13)
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1
University of Alabama At Birmingham
Birmingham, Alabama, United States
2
University of California At San Francisco
San Francisco, California, United States
3
Georgetown University
Washington D.C., District of Columbia, United States
4
University of Chicago
Chicago, Illinois, United States