A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Phase 3 Study of Denosumab as Adjuvant Treatment for Women With Early-Stage Breast Cancer at High Risk of Recurrence (D-CARE)

Trial Profile

A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Phase 3 Study of Denosumab as Adjuvant Treatment for Women With Early-Stage Breast Cancer at High Risk of Recurrence (D-CARE)

Discontinued
Phase of Trial: Phase III

Latest Information Update: 11 May 2018

At a glance

  • Drugs Denosumab (Primary)
  • Indications Early breast cancer
  • Focus Biomarker; Pharmacogenomic; Registrational; Therapeutic Use
  • Acronyms D-CARE
  • Sponsors Amgen
  • Most Recent Events

    • 20 Apr 2018 Status changed from active, no longer recruiting to discontinued due to Amgen decision following Primary Analysis. Not due to safety reason
    • 02 Feb 2018 According to a Daiichi Sankyo media release, detailed results will be submitted to a future medical conference or publication.
    • 02 Feb 2018 According to a Daiichi Sankyo media release, primary endpoint (Bone metastasis-free survival) has not been met.
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