Clinical Trial VICCBRE1280

Title

A Phase III Randomized, Double Blind Placebo Controlled Study of BKM120 with Fulvestrant, in Postmenopausal Women with Hormone Receptor-Positive HER2-Negative Locally Advanced or Metastatic Breast Cancer Which Progressed On or After Aromatase Inhibitor Treatment

Principal Investigator(s)

Ingrid Mayer

Details

  • Protocol No. VICCBRE1280
  • Open Date: 02/07/2013
  • Staging: Phase III
  • Age Group: Adults
  • Scope: National
  • Objective: To determine whether treatment with BKM120 plus fulvestrant prolongs PFS based on local investigator assessment compared to treatment with placebo plus fulvestrant for all patients regardless of PI3K pathway activation status (full population) and for PI3K pathway activated sub-population.
  • Disease Sites: Breast
  • Therapies: Hormonal Therapy; Molecular Targeted Agents / Immunotherapy / Biologics
  • Drugs: BKM120; Fulvestrant
  • Participating Institutions: Vanderbilt University
  • National Clinical Trial ID: NCT01610284
  • Secondary Protocol No: CBKM120F2302

Description

Eligibility

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