A Phase 3, Multi-Center Study of Gemcitabine/Carboplatin, With or Without BSI-201, in Patients With ER-, PR-, and Her2-Negative Metastatic Breast Cancer
Public ClinicalTrials.gov record NCT00938652. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 3, Multi-Center, Open-Label, Randomized Study of Gemcitabine/Carboplatin, With or Without BSI-201, in Patients With ER-, PR-, and Her2-Negative Metastatic Breast Cancer
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The goal of this study was to determine the effect on overall survival and progression free survival by adding iniparib (BSI-201/SAR240550) to the combination of gemcitabine/carboplatin in adult patients with triple negative breast cancer (estrogen receptor (ER)-negative, progesterone receptor (PR)-negative, and human epidermal growth factor receptor 2 (HER2)-negative). Based on data generated by BiPar/Sanofi, it is 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.
Study identification
- NCT ID
- NCT00938652
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 519 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- Female
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 2009 (Type not available)
- Primary completion
- Jan 2011 (Actual)
- Completion
- Feb 2012 (Actual)
- Last update posted
- Sep 19, 2013
2009 – 2012
United States locations
- U.S. sites
- 102
- U.S. states
- 35
- U.S. cities
- 101
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Research Site | Birmingham | Alabama | — | — |
| Research Site | Sedona | Arizona | — | — |
| Research Site | Jonesboro | Arkansas | — | — |
| Research Site | Alhambra | California | — | — |
| Research Site | Bakersfield | California | — | — |
| Research Site | Campbell | California | — | — |
| Research Site | Fullerton | California | — | — |
| Research Site | Lancaster | California | — | — |
| Research Site | Long Beach | California | — | — |
| Research Site | Los Angeles | California | — | — |
| Research Site | Nothridge | California | — | — |
| Research Site | Oxnard | California | — | — |
| Research Site | Palo Alto | California | — | — |
| Research Site | Pomona | California | — | — |
| Research Site | Redondo Beach | California | — | — |
| Research Site | San Francisco | California | — | — |
| Research Site | Santa Barbara | California | — | — |
| Research Site | Santa Maria | California | — | — |
| Research Site | Sylmar | California | — | — |
| Research Site | Vallejo | California | — | — |
| Research Site | Westlake Village | California | — | — |
| Research Site | Whittier | California | — | — |
| Research Site | Denver | Colorado | — | — |
| Research Site | Grand Junction | Colorado | — | — |
| Research Site | Washington D.C. | District of Columbia | — | — |
| Research Site | Bonita Springs | Florida | — | — |
| Research Site | Gainesville | Florida | — | — |
| Research Site | Hollywood | Florida | — | — |
| Research Site | Jacksonville | Florida | — | — |
| Research Site | Miami | Florida | — | — |
| Research Site | Ocala | Florida | — | — |
| Research Site | Ocoee | Florida | — | — |
| Research Site | Orange Park | Florida | — | — |
| Research Site | Orlando | Florida | — | — |
| Research Site | Port Saint Lucie | Florida | — | — |
| Research Site | Albany | Georgia | — | — |
| Research Site | Athens | Georgia | — | — |
| Research Site | Atlanta | Georgia | — | — |
| Research Site | Augusta | Georgia | — | — |
| Research Site | Lawrenceville | Georgia | — | — |
| Research Site | Macon | Georgia | — | — |
| Research Site | Marietta | Georgia | — | — |
| Research Site | Savannah | Georgia | — | — |
| Research Site | Coeur d'Alene | Idaho | — | — |
| Research Site | Chicago | Illinois | — | — |
| Research Site | Indianapolis | Indiana | — | — |
| Research Site | Overland Park | Kansas | — | — |
| Research Site | Westwood | Kansas | — | — |
| Research Site | Baltimore | Maryland | — | — |
| Research Site | Chevy Chase | Maryland | — | — |
| Research Site | Westminster | Maryland | — | — |
| Research Site | Boston | Massachusetts | — | — |
| Research Site | Ann Arbor | Michigan | — | — |
| Research Site | Royal | Michigan | — | — |
| Research Site | Minneapolis | Minnesota | — | — |
| Research Site | Rochester | Minnesota | — | — |
| Research Site | Jackson | Mississippi | — | — |
| Research Site | Columbia | Missouri | — | — |
| Research Site | St Louis | Missouri | — | — |
| Reserach Site | Billings | Montana | — | — |
| Research Site | Grand Island | Nebraska | — | — |
| Research Site | Las Vegas | Nevada | — | — |
| Research Site | Hooksett | New Hampshire | — | — |
| Research Site | Morristown | New Jersey | — | — |
| Research Site | Sparta | New Jersey | — | — |
| Research Site | Santa Fe | New Mexico | — | — |
| Research Site | Amsterdam | New York | — | — |
| Research Site | East Setauket | New York | — | — |
| Research Site | New York | New York | — | — |
| Research Site | Chapel Hill | North Carolina | — | — |
| Research Site | Charlotte | North Carolina | — | — |
| Research Site | Durham | North Carolina | — | — |
| Reserach Site | Durham | North Carolina | — | — |
| Research Site | Greensboro | North Carolina | — | — |
| Research Site | Raleigh | North Carolina | — | — |
| Research Site | Winston-Salem | North Carolina | — | — |
| Research Site | Cincinnati | Ohio | — | — |
| Research Site | Toledo | Ohio | — | — |
| Research Site | Portland | Oregon | — | — |
| Research Site | Philadelphia | Pennsylvania | — | — |
| Research Site | Pittsburgh | Pennsylvania | — | — |
| Reserach Site | Columbia | South Carolina | — | — |
| Research Site | Chattanooga | Tennessee | — | — |
| Research Site | Memphis | Tennessee | — | — |
| Research Site | Nashville | Tennessee | — | — |
| Research Site | Austin | Texas | — | — |
| Research Site | Bedford | Texas | — | — |
| Research Site | Dallas | Texas | — | — |
| Research Site | Fort Worth | Texas | — | — |
| Research Site | Fredericksburg | Texas | — | — |
| Research Site | Houston | Texas | — | — |
| Research Site | Tyler | Texas | — | — |
| Research Site | Salt Lake City | Utah | — | — |
| Research Site | Fairfax | Virginia | — | — |
| Research Site | Norfolk | Virginia | — | — |
| Research Site | Richmond | Virginia | — | — |
| Research Site | Roanoke | Virginia | — | — |
| Research Site | Suffolk | Virginia | — | — |
| Research Site | Kennewick | Washington | — | — |
| Research Sites | Seattle | Washington | — | — |
| Research Site | Vancouver | Washington | — | — |
| Research Site | Yakima | Washington | — | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00938652, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 19, 2013 · Synced Oct 21, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00938652 live on ClinicalTrials.gov.