Ribociclib+Endocrine Therapy as Ad Tx in HR+/HER2Breast Cancer

March 15, 2019

A phase III, multicenter, randomized, open-label trial to evaluate efficacy and safety of ribociclib with endocrine therapy as an adjuvant treatment in patients with hormone receptor-positive, HER2-negative, early breast cancer (New Adjuvant TriAl with Ribociclib [LEE011]: NATALEE).

  • Clinical Trial Information

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

  • IRB No: WIRB 20182329

    Protocol Abbrev: TRIO NATALEE

    Principal Investigator: Ana Elisa Cuesta Fernandez, MD

    Phase: Drug: Phase III

    Age Group: Adult

    Secondary Protocol No: TALEE TRIO 033

    Treatment: Ribociclib with endocrine therapy as an adjuvant treatment

    Therapies Involved: Oncology: Adjuvant

    ClinicalTrials.gov ID: NCT03701334

  • Objective

    The purpose is to evaluate the effect of the addition of ribociclib to standard adjuvant ET on iDFS in patients with HR-positive, HER2-negative Anatomic Stage Group II (that is either: N1; or N0 (T2-3, N0) with G2-3 and/or Ki67≥20%, excluding G1) and Anatomic Stage Group III EBC.

  • Key Eligibility

    Inclusion:
    •   Female or male ≥ 18 years-old.
    •   Female with known menopausal status or initiation of adjuvant ET (whichever occurs earlier)
    •   Histologically confirmed unilateral primary invasive adenocarcinoma of the breast with a date of initial cytologic or histologic diagnosis within 18 months prior to randomization
    •   Positive for ER and/or PgR. HER2-negative
    •   Available archival tumor tissue
    Exclusion
    •   Patient has received any CDK4/6 inhibitor
    •   Received prior treatment with tamoxifen, raloxifene or AIs for reduction in risk ("chemoprevention") of breast cancer and/or treatment for osteoporosis within the last 2 years
    •   Prior treatment with anthracyclines at cumulative doses of 450 mg/m² or more for doxorubicin, or 900 mg/m² or more for epirubicin