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A ctDNA Screening Program in Patients With HR+, HER2- Metastatic Breast Cancer for Detection of High-risk Relapse Patients on Any CDK4/6 Inhibitor and a Randomised Phase II Study Comparing Alpelisib Combined With Fulvestrant to Ribociclib Combined With Fulvestrant, in Patients With Persistent Targetable PIK3CA Mutations

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A ctDNA Screening Program in Patients With HR+, HER2- Metastatic Breast Cancer for Detection of High-risk Relapse Patients on Any CDK4/6 Inhibitor and a Randomised Phase II Study Comparing Alpelisib Combined With Fulvestrant to Ribociclib Combined With Fulvestrant, in Patients With Persistent Targetable PIK3CA Mutations

Status: Recruiting
Phase of Trial: Phase II

Latest Information Update: 01 Feb 2025

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At a glance

  • Drugs Alpelisib (Primary) ; Fulvestrant (Primary) ; Ribociclib
  • Indications Breast cancer; HER2 negative breast cancer; HER2 positive breast cancer; Male breast cancer
  • Focus Therapeutic Use
  • Acronyms SAFIR 03

    • Most Recent Events

    • 16 Nov 2023 Status changed from not yet recruiting to recruiting.
    • 04 Sep 2023 Planned initiation date changed from 1 Jun 2023 to 1 Nov 2023.
    • 08 Mar 2023 Planned initiation date changed from 1 Feb 2023 to 1 Jun 2023.

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