A Phase 2 Trial of Standard Chemotherapy, With or Without BSI-201, in Patients With Triple Negative Metastatic Breast Cancer
A Phase 2, Multi-center, Open-Label, Randomized Trial of Gemcitabine/ Carboplatin, With or Without BSI-201, in Patients With ER, PR and HER2-negative Metastatic Breast Cancer
2 other identifiers
interventional
123
1 country
18
Brief Summary
The purpose of this clinical trial was to determine whether combining iniparib (BSI-201) with standard chemotherapy in estrogen receptor (ER)-negative, progesterone receptor (PR)-negative, and human epidermal growth factor receptor 2 (HER2) negative metastatic breast cancer patients improve clinical benefit compared to treatment with standard chemotherapy alone. Based on data generated by BiPar/Sanofi, it was concluded that iniparib does not possess characteristics typical of the poly (ADP-ribose) polymerase (PARP) inhibitor class. The exact mechanism has not yet been fully elucidated, however based on experiments on tumor cells performed in the laboratory, iniparib is a novel investigational anti-cancer agent that induces gamma-H2AX (a marker of DNA damage) in tumor cell lines, induces cell cycle arrest in the G2/M phase in tumor cell lines, and potentiates the cell cycle effects of DNA damaging modalities in tumor cell lines. Investigations into potential targets of iniparib and its metabolites are ongoing.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 breast-cancer
Started Oct 2007
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2007
CompletedFirst Submitted
Initial submission to the registry
October 4, 2007
CompletedFirst Posted
Study publicly available on registry
October 8, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2010
CompletedDecember 28, 2012
December 1, 2012
2.1 years
October 4, 2007
December 21, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Clinical benefit rate
Clinical benefit rate was defined as the percentage of patients with complete response, partial response or stable disease ≥6 months.
until cut-off date established so that all patients were evaluable for primary outcome measure
Secondary Outcomes (2)
Objective response rate
until cut-off date established so that all patients were evaluable for primary outcome measure
Progression-free survival
until cut-off date established so that all patients were evaluable for primary outcome measure
Study Arms (2)
Arm G/C
ACTIVE COMPARATORStandard chemotherapy with gemcitabine/carboplatin on Days 1 and 8 of 21-day cycle(s)
Arm G/C/I
EXPERIMENTALStandard chemotherapy with gemcitabine/carboplatin on Days 1 and 8, plus iniparib on Days 1, 4, 8, and 11 of 21-day cycle(s)
Interventions
Gemcitabine and carboplatin administered according to instructions in the package inserts.
Body weight adjusted dose 1 hour intravenous infusion
Eligibility Criteria
You may qualify if:
- At least 18 years of age;
- Metastatic breast cancer (Stage IV) with measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) criteria;
- prior chemotherapy regimens in the metastatic setting;
- Histologically documented (either primary or metastatic site) breast cancer that was ER-negative, PR-negative, and HER-2 nonoverexpressing by immunohistochemistry (0,1) or non-gene amplification by fluorescence in situ hybridization (FISH);
- Completion of prior chemotherapy at least 2 weeks prior to trial entry and recovery from toxicity of prior chemotherapy;
- Radiation therapy must have been completed at least 2 weeks prior to trial entry, and radiated lesions may not have served as measurable disease;
- Patient may have had central nervous system (CNS) metastases if he/she did not require steroids, whole brain radiation therapy (XRT), gamma/cyber knife, and brain metastases were clinically stable without symptomatic progression;
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1;
- Adequate organ function defined as: absolute neutrophil count (ANC)≥1,500/mm3, platelets ≥100,000/mm3, creatinine clearance \>50mL/min, ALT and AST \<2.5 x upper limit of normal (ULN) (or \<5 x ULN in case of liver metastases); total bilirubin \<1.5 mg/dL.
- Tissue block (primary or metastatic) available for PARP and PG studies was recommended, although its absence did not exclude subjects from participating;
- Woman of child bearing potential must have had documented negative pregnancy test within two weeks of trial entry and agreed to acceptable birth control during the duration of the trial therapy;
- Signed, IRB approved written informed consent.
You may not qualify if:
- Lesions identifiable only by positron emission tomography (PET);
- Prior treatment with gemcitabine, carboplatin, cisplatin or iniparib;
- Major medical conditions that might have affected trial participation (uncontrolled pulmonary, renal, or hepatic dysfunction, uncontrolled infection);
- Significant history of uncontrolled cardiac disease; i.e. uncontrolled hypertension, unstable angina, recent myocardial infarction (within prior 6 months), uncontrolled congestive heart failure, and cardiomyopathy that was either symptomatic or asymptomatic but with decreased ejection fraction \<45%;
- Other significant comorbid condition which the investigator felt might compromise effective and safe participation in the trial;
- Patient enrolled in another investigational device or drug trial, or was receiving other investigational agents;
- Concurrent or prior (within 7 days of trial day 1) anticoagulation therapy (low dose for port maintenance allowed);
- Concurrent radiation therapy was not permitted throughout the course of the trial;
- Inability to comply with the requirements of the trial;
- Pregnant or lactating woman;
- Leptomeningeal disease or brain metastases requiring steroids or other therapeutic intervention.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sanofilead
- BiPar Sciencescollaborator
Study Sites (18)
Research Site
Birmingham, Alabama, United States
Research Site
Denver, Colorado, United States
Research Site
Torrington, Connecticut, United States
Research Site
Ocoee, Florida, United States
Research Site
Indianapolis, Indiana, United States
Research Site
Overland Park, Kansas, United States
Research Site
Henderson, Nevada, United States
Research Site
Hooksett, New Hampshire, United States
Research Site
Raleigh, North Carolina, United States
Research Site
Bedford, Texas, United States
Research Site
Dallas, Texas, United States
Research Site
El Paso, Texas, United States
Research Site
Fort Worth, Texas, United States
Research Site
Houston, Texas, United States
Research Site
Tyler, Texas, United States
Research Site
Fairfax, Virginia, United States
Research Site
Vancouver, Washington, United States
Research Site
Yakima, Washington, United States
Related Publications (1)
O'Shaughnessy J, Osborne C, Pippen JE, Yoffe M, Patt D, Rocha C, Koo IC, Sherman BM, Bradley C. Iniparib plus chemotherapy in metastatic triple-negative breast cancer. N Engl J Med. 2011 Jan 20;364(3):205-14. doi: 10.1056/NEJMoa1011418. Epub 2011 Jan 5.
PMID: 21208101RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Sciences & Operations
Sanofi
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
- Expanded Access
- Yes
Study Record Dates
First Submitted
October 4, 2007
First Posted
October 8, 2007
Study Start
October 1, 2007
Primary Completion
November 1, 2009
Study Completion
June 1, 2010
Last Updated
December 28, 2012
Record last verified: 2012-12