Tucatinib for Metastatic HER2+ Breast Carcinoma

Phase 2 Randomized, Double-Blinded, Controlled Study of Tucatinib vs Placebo in Combination With Capecitabine and Trastuzumab in Patients With Pretreated Unresectable Locally Advanced or Metastatic HER2+ Breast Carcinoma (HER2CLIMB)

November 22, 2017

  • Clinical Trial Information

    Trial Contact: Jobson, Gillian S; Morales, Leticia; Pelley, Jennifer

    Trial Phone: 321.841.2285 ; 321.841.6696 ; 321.841.4348

  • IRB No: WIRB 20152617

    Protocol Abbrev: TRIO ONT-380-206

    Principal Investigator: Rebecca L. Moroose, MD

    Sub Investigators: Cuesta, Ana MD; Rostorfer, Regan MD; Shah, Nikita MD; Baidas, Said MD

    Phase: Drug: Phase II

    Age Group: Adult

    Secondary Protocol No: TRIO Cascadian

    Treatment: Chemotherapy

    Applicable Disease Sites: Breast Cancer

    Therapies Involved: Tucatinib

    ClinicalTrials.gov ID: NCT02614794

  • Objective

    To assess the effect of tucatinib vs. placebo in combination with capecitabine and trastuzumab on progression-free survival

  • Key Eligibility

    Have histologically confirmed HER2+ breast carcinoma, with HER2+ defined by fluorescence in situ hybridization (FISH) and/or 3+ staining by immunohistochemistry (IHC)
    Have received previous treatment with a taxane, trastuzumab, pertuzumab, and T-DM1
    Have progression of unresectable locally advanced or metastatic breast cancer after last systemic therapy (as confirmed by investigator), or be intolerant of last systemic therapy
    Have measurable or non-measurable disease assessable by RECIST 1.1
    Have Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0 or 1
    Have adequate hepatic and renal function
    Have left ventricular ejection fraction (LVEF) ≥ 50%
    CNS Inclusion - Based on screening brain magnetic resonance imaging (MRI), patients must have one of the following:
    No evidence of brain metastases
    Untreated brain metastases not needing immediate local therapy
    Previously treated brain metastases
    1.Brain metastases previously treated with local therapy may either be stable since treatment or may have progressed since prior local CNS therapy
    2.Patients treated with CNS local therapy for newly identified lesions found on initial MRI performed during screening for this study may be eligible to enroll if all of the following criteria are met:
    Time since whole brain radiation therapy (WBRT) is > 21 days prior to first dose of study treatment, time since stereotactic radiosurgery (SRS) is > 7 days prior to first dose of study treatment, or time since surgical resection is > 28 days
    Other sites of evaluable disease are present
    Relevant records of any CNS treatment must be available to allow for classification of target and non-target lesions