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.

Trial Profile

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.

Completed
Phase of Trial: Phase II

Latest Information Update: 27 Dec 2012

At a glance

  • Drugs Carboplatin (Primary) ; Gemcitabine (Primary) ; Iniparib (Primary)
  • Indications Advanced breast cancer
  • Focus Adverse reactions; Therapeutic Use
  • Most Recent Events

    • 26 May 2011 Actual end date changed from 11 Dec 2009 to Jun 2010 as reported by ClinicalTrials.gov.
    • 12 Oct 2010 Final efficacy results were presented at the 35th Congress of the European Society for Medical Oncology.
    • 10 Oct 2010 Regulatory submissions are planned for Q1 2011 in the US and Q2 2011 in the EU, according to a sanofi aventis and BiPar Sciences media release.
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