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A Phase Ib/II, Open-Label, Multicenter, Randomized Umbrella Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Breast Cancer (MORPHEUS-BREAST CANCER)

Trial Profile

A Phase Ib/II, Open-Label, Multicenter, Randomized Umbrella Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Breast Cancer (MORPHEUS-BREAST CANCER)

Status: Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 19 Mar 2025

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At a glance

  • Drugs Abemaciclib (Primary) ; Atezolizumab (Primary) ; Everolimus (Primary) ; Giredestrant (Primary) ; Inavolisib (Primary) ; Ipatasertib (Primary) ; Palbociclib (Primary) ; Pertuzumab/trastuzumab (Primary) ; Ribociclib (Primary) ; Samuraciclib (Primary)
  • Indications Advanced breast cancer; HER2 positive breast cancer
  • Focus Adverse reactions; Pharmacokinetics; Therapeutic Use
  • Acronyms MORPHEUS BC
  • Sponsors Roche
  • Most Recent Events

    • 17 Feb 2025 Protocol was amended to increase the number of arms form 12 to 15, adding Palbociclib in one of the new treatment arm. The study will have flexibility to open new treatment arms as new treatments become available, close existing treatment arms that demonstrate minimal clinical activity or unacceptable toxicity, or modify the patient population.
    • 17 Feb 2025 Planned number of patients changed from 510 to 316.
    • 05 Feb 2025 Planned primary completion date changed from 30 Apr 2026 to 30 Nov 2027.

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