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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

Phase 2
18 Years
Not Enrolling
Breast Cancer

Thank you

Trial Information

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

Patients were treated until disease progression, unacceptable toxicity, Investigator's
decision to discontinue, or withdrawal of consent. After treatment discontinuation, all
patients were evaluated every 90 days after last dose of gemcitabine/carboplatin with or
without iniparib, for up to 3 years or death or end of study, which ever occurred first.

Inclusion Criteria:

- At least 18 years of age;

- Metastatic breast cancer (Stage IV) with measurable disease by Response Evaluation
Criteria in Solid Tumors (RECIST) criteria;

- 0-2 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

- 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.

Exclusion Criteria:

- 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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Clinical benefit rate

Outcome Description:

Clinical benefit rate was defined as the percentage of patients with complete response, partial response or stable disease ≥6 months.

Outcome Time Frame:

until cut-off date established so that all patients were evaluable for primary outcome measure

Safety Issue:


Principal Investigator

Clinical Sciences & Operations

Investigator Role:

Study Director

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




Start Date:

October 2007

Completion Date:

June 2010

Related Keywords:

  • Breast Cancer
  • Triple negative breast cancer
  • Breast Neoplasms



Research SiteAlabaster, Alabama  
Research SiteBoulder, Colorado  
Research SiteDanbury, Connecticut  
Research SiteBoca Raton, Florida  
Research SiteBloomington, Indiana  
Research SiteHays, Kansas  
Research SiteLas Vegas, Nevada  
Research SiteHooksett, New Hampshire  
Research SiteAsheville, North Carolina  
Research SiteAbilene, Texas  
Research SiteAbington, Virginia  
Research SiteAuburn, Washington