Having a large clinical trial portfolio means giving patients treatment options often not available anywhere else, and years before they become the standard of care. To learn more about Karmanos Cancer Institute clinical trials or to see if a trial is right for you, please call 1-800-KARMANOS (1-800-527-6266) or request an appointment below
  • A Phase III, Multicenter, Randomized, Open-Label Study Evaluating the Efficacy and Safety of Inavolisib Plus Fulvestrant Versus Alpelisib Plus Fulvestrant in Patients with Hormone Receptor-Positive, Her2-Negative, Pik3ca Mutated, Locally Advanced or Metastatic Breast Cancer Who Progressed During Or After Cdk4/6 Inhibitor And Endocrine Combination Therapy

    Cancer Categories
    • Breast
    Karmanos Trial ID
    • 2023-057
    NCT ID
    • NCT05646862
    Age Group
    • Adult
    • National
    PhaseClick for Clinical Trial Phase DefinitionPhase III
    Includes trials conducted after preliminary evidence suggesting effectiveness of the drug has been obtained, and are intended to gather additional information to evaluate the overall benefit-risk relationship of the drug
    • Phase III
    Principal Investigator


    Primary Objective:

    • To evaluate the efficacy of inavolisib plus fulvestrant compared with alpelisib plus fulvestrant.

    Secondary Objectives:

    • To evaluate patient-reported pain, functioning, and HRQoL among participants treated with inavolisib plus fulvestrant compared with alpelisib plus fulvestrant
    • To evaluate the safety and tolerability of inavolisib plus fulvestrant compared with alpelisib plus fulvestrant
    • To characterize the pharmacokinetics of inavolisib in the inavolisib plus fulvestrant arm
  • Locations


    Karmanos Cancer Institute - Detroit Headquarters

    4100 John R
    Detroit, MI 48201
    Get Directions
    Phone: 800-527-6266

    Karmanos Cancer Institute at Weisberg Cancer Center - Farmington Hills

    31995 Northwestern Hwy
    Farmington Hills, MI 48334
    Get Directions
    Phone: 800-527-6266