Phase 3 Hormone-Receptor-Positive, HER2-Normal Breast Cancer

Phase III Study Evaluating Palbociclib (PD-0332991), a Cyclin-Dependent Kinase (CDK) 4/6 Inhibitor in Patients with Hormone-Receptor-Positive, HER2-Normal Primary Breast Cancer with High Relapse Risk after Neoadjuvant Chemotherapy

November 22, 2017

  • Clinical Trial Information

    Trial Contact: Pelley, Jennifer

    Trial Phone: 321.841.4348

  • IRB No: 15.002.01

    Protocol Abbrev: B-54

    Principal Investigator: Regan Derek Rostorfer, MD

    Sub Investigators: Baidas, Said MD; Mamounas, Eleftherios MD; Moroose, Rebecca MD; Shah, Nikita MD

    Phase: Drug: Phase III

    Age Group: Adult

    Secondary Protocol No: NSABP B-54/Penelope

    Treatment: Medication; HER2+

    Applicable Disease Sites: Breast

    Therapies Involved: Palbociclib or placebo at a dose of 125 mg once daily, day 1 to day 21 followed by 7 days off treatment in a 28-day cycle for thirteen cycles

    ClinicalTrials.gov ID: NCT01864746

  • Objective

    The PENELOPE study is designed to demonstrate that in the background of standard anti-hormonal therapy palbociclib provides superior invasive disease-free survival (iDFS) compared to placebo in pre- and postmenopausal women with HR-positive/HER2-normal early breast cancer at high risk of relapse after showing less than pathological complete response to neoadjuvant taxane- containing chemotherapy.

  • Key Eligibility

    Breast Cancer
    Hormone receptor Positive
    Her2-normal
    Postneoadjuvant Treatment With CDK 4/6 Inhibitor
    CPS-EG Score