A Phase III Prospective, Two-Cohort Non-Randomized, Multi-Centre, Multinational, Open-Label Study to Assess the Safety of Assisted- and Self-Administered Subcutaneous Trastuzumab as Therapy in Patients With Operable HER2-Positive Early Breast Cancer

Trial Profile

A Phase III Prospective, Two-Cohort Non-Randomized, Multi-Centre, Multinational, Open-Label Study to Assess the Safety of Assisted- and Self-Administered Subcutaneous Trastuzumab as Therapy in Patients With Operable HER2-Positive Early Breast Cancer

Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 01 Sep 2017

At a glance

  • Drugs Trastuzumab (Primary)
  • Indications Early breast cancer; Male breast cancer
  • Focus Adverse reactions; Registrational
  • Acronyms SafeHer
  • Sponsors Roche
  • Most Recent Events

    • 01 Sep 2017 Results of the primary analysis (n=2573), published in the European Journal of Cancer
    • 11 Oct 2016 Results of a subgroup analysis of body weights, active medical condition, safety and tolerability presented at the 41st European Society for Medical Oncology Congress.
    • 01 Dec 2015 Status changed from recruiting to active, no longer recruiting as reported by ClinicalTrials.gov record.
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