Phase 2 of MLN0128 with Fulvestrant with ER-Positive/HER2-

An Open-Label Phase 2 Study of MLN0128 (A TORC1/2 Inhibitor) in Combination With Fulvestrant in Women With ER-Positive/HER2-Negative Advanced or Metastatic Breast Cancer That Has Progressed During or After Aromatase Inhibitor Therapy

November 22, 2017

  • Clinical Trial Information

    Trial Contact: Jobson, Gillian S; Pelley, Jennifer

    Trial Phone: 321.841.2285 ; 321.841.4348

  • IRB No: WIRB 20160704

    Protocol Abbrev: TRIO C31006

    Principal Investigator: Regan Derek Rostorfer, MD

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

    Phase: Drug: Phase II

    Age Group: Adult

    Secondary Protocol No: TRIO 027

    Treatment: MLN0128

    Applicable Disease Sites: Breast

    Therapies Involved: Medication ID: NCT02756364

  • Objective

    To compare the PFS of patients treated with the combination of fulvestrant+daily MLN0128 versus patients treated with single-agent fulvestrant.

  • Key Eligibility

    Female patients aged 18 years or older who are postmenopausal
    Histologically proven diagnosis of breast cancer with evidence of metastatic disease or locoregional recurrence, not amenable to resection or radiation therapy with curative intent
    Histological confirmation and documentation of ER-positive status
    Histological or cytological confirmation and documentation of HER2-negative status
    ECOG performance status of 0 or 1