An Open-Label Randomized, Parallel, Two-Arm Phase II Study Comparing BMS-690514 + Letrozole with Lapatinib + Letrozole in Recurrent or Metastatic Breast Cancer Patients Who Are Hormone Receptor Positive Despite HER2 Status And Who Relapsed While Receiving or After Completing Adjuvant Antiendocrine Therapy Revised Protocol 02, incorporating Protocol Amendments 02 and 04 + Pharmacogenetics Blood Sample Amendment Number 01 - Site Specific (version 1.0 dated 20-Nov-09)

Trial Profile

An Open-Label Randomized, Parallel, Two-Arm Phase II Study Comparing BMS-690514 + Letrozole with Lapatinib + Letrozole in Recurrent or Metastatic Breast Cancer Patients Who Are Hormone Receptor Positive Despite HER2 Status And Who Relapsed While Receiving or After Completing Adjuvant Antiendocrine Therapy Revised Protocol 02, incorporating Protocol Amendments 02 and 04 + Pharmacogenetics Blood Sample Amendment Number 01 - Site Specific (version 1.0 dated 20-Nov-09)

Completed
Phase of Trial: Phase II

Latest Information Update: 23 May 2013

At a glance

  • Drugs BMS 690514 (Primary) ; Lapatinib; Letrozole
  • Indications Advanced breast cancer
  • Focus Biomarker; Pharmacogenomic; Therapeutic Use
  • Most Recent Events

    • 23 May 2013 Planned number of patients changed from 140 to 175 as reported by European Clinical Trials Database.
    • 07 Apr 2011 Actual end date (Dec 2010) added as reported by ClinicalTrials.gov.
    • 07 Apr 2011 Status changed from recruiting to completed as reported by ClinicalTrials.gov.
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