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Phase 2 study of Letrozole-ISM vs Femara

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Trial Profile

Phase 2 study of Letrozole-ISM vs Femara

Status: Planning
Phase of Trial: Phase II

Latest Information Update: 08 May 2023

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At a glance

  • Drugs Letrozole (Primary)
  • Indications Advanced breast cancer
  • Focus Registrational; Therapeutic Use

Most Recent Events

  • 25 Apr 2023 According to Rovi media release, in the light of the advice received from the FDA, the clinical development that would foreseeably be required to obtain marketing authorisation (at least in the United States) for the annual formulation of Letrozole ISM would entail this phase 2 and, subsequently, a Phase 3 trial in women with early breast cancer.
  • 02 Mar 2023 New trial record

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