Abemaciclib With HR+, HER2+ Advanced or Metastatic breast

monarcHER: A Phase 2, Randomized, Multicenter, 3-Arm, Open-Label Study to Compare the Efficacy of Abemaciclib plus Trastuzumab with or without Fulvestrant to Standard-of-Care Chemotherapy of Physician’s Choice plus Trastuzumab in Women with HR+, HER2+ Locally Advanced or Metastatic Breast Cancer

November 22, 2017

  • Clinical Trial Information

    Trial Contact: Pelley, Jennifer; Morales, Leticia

    Trial Phone: 321.841.4348 ; 321.841.6696

  • IRB No: WIRB 1164476

    Protocol Abbrev: TRIO I3Y-MC-JPBZ

    Principal Investigator: Regan Derek Rostorfer, MD

    Sub Investigators: Shah, Nikita MD; Moroose, Rebecca MD; Baidas, Said MD; Cuesta, Ana MD

    Phase: Drug: Phase II

    Age Group: Adult

    Secondary Protocol No: I3Y-MC-JPBZ

    Treatment: Chemotherapy

    Applicable Disease Sites: Breast Cancer

    Therapies Involved: Abemaciclib (LY2835219)

    ClinicalTrials.gov ID: NCT02675231

  • Objective

    The primary objective of this study is to compare the efficacy of abemaciclib plus trastuzumab plus fulvestrant and abemaciclib plus trastuzumab to standard-of-care single-agent chemotherapy of physician’s choice plus trastuzumab with respect to progression free survival (PFS).

  • Key Eligibility

    diagnosis of HR+, HER2+ breast cancer (BC)
    unresectable locally advanced recurrent BC or metastatic BC
    previously received:
    ◦at least 2 HER2-directed therapies for advanced disease
    ◦participant must have received trastuzumab emtansine (T-DM1) in any disease setting
    postmenopausal status