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PIPELINE > TRIAL OVERVIEW

Trial Information
Molecule Overview
Pan-Mutant Selective PI3Kα Inhibitor
LY4064809
Phase
3
Recruiting
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of LY4064809 Combined With a CDK4/6 Inhibitor and Endocrine Therapy in Adults With HR+, HER2- Advanced Breast Cancer With a PIK3CA Mutation Who Received No Prior Treatment for Advanced Breast Cancer
Related Resources:
Trial Enrollment
PIKALO-2 Trial
Key Inclusion Criteria
  • If assigned female at birth, pre-/peri- and postmenopausal status is allowed. If pre- or peri-menopausal status at study entry must agree to use ovarian function suppression with any locally approved gonadotropin-releasing hormone (GnRH) agonist
  • If assigned male at birth with an estrogen receptor positive (ER+) breast cancer diagnosis, they must agree to use hormone suppression with a GnRH agonist
  • Histologically or cytologically confirmed breast cancer, defined as individuals with
    • Locally advanced breast cancer not amenable to curative therapy (for example, surgery) or metastatic disease, and
    • Hormone receptors (HR)+/human epidermal growth factor receptor 2 (HER2)- or HR+/HER low defined by American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) Guidelines
      • HR status: Documented ER+ and/or progesterone receptor-positive (PR+) tumor according to ASCO/CAP Guidelines, defined as ≥1 percent of tumor cells stained positive based on the most recent tumor biopsy and assessed locally
      • HER status: Immunohistochemistry score of 1+ or score of 2+ with a negative fluorescence in situ hybridization (FISH) based on local results as defined in the ASCO/CAP Guidelines
  • Evidence of an activating PIK3CA mutation, detected in tumor or blood samples using an appropriate assay
  • Measurable disease or non-measurable, evaluable bone disease
  • Part 1:
    • Received 0-2 prior systemic treatments for advanced breast cancer not amenable to curative therapy (for example, surgery) or metastatic disease
    • Up to 1 of these prior systemic treatments may contain chemotherapy
  • Part 2:
    • Received 0 prior systemic treatment for advanced breast cancer not amenable to curative therapy (for example, surgery) or metastatic disease
    • Individuals who are eligible are either
      • Population 1: Endocrine sensitive
        • Newly diagnosed with advanced breast cancer (de novo)
        • Relapsed with documented evidence of progression >12 months from completion of (neo)adjuvant ET ± CDK4/6 inhibitor, or
      • Population 2: Endocrine resistant
        • Relapsed with documented evidence of progression ≤12 months of completing (neo)adjuvant ET ± CDK4/6 inhibitor
        • If a CDK4/6 inhibitor was included as part of neoadjuvant or adjuvant therapy, progression event must be >12 months since completion of CDK4/6 inhibitor portion of neoadjuvant or adjuvant therapy
Key Exclusion Criteria
  • Diagnosis of type 1 diabetes mellitus or type 2 diabetes mellitus with hemoglobin A1c (HbA1c) ≥8%, fasting blood glucose (FBG) ≥140 milligrams per deciliter (mg/dL) (7.7 millimoles per liter [mmol/L]), or requiring insulin
  • Inflammatory or metaplastic breast cancer
  • History of leptomeningeal disease or carcinomatous meningitis
  • Known and untreated or active central nervous system (CNS) metastases. Exception: Asymptomatic brain or spinal metastases if treated by surgery, surgery plus radiotherapy, or radiotherapy alone with no evidence of radiographic progression or hemorrhage within at least 28 days before randomization and no requirement for anticonvulsants or systemic corticosteroids for at least 28 days before randomization
    • Received treatment with any local or systemic antineoplastic therapy or investigational anticancer agent within 14 days or 4 half-lives, whichever is longer, prior to randomization up to a maximum washout period of 28 days
    • Diagnosis of immunodeficiency or receiving chronic systemic steroid therapy (dose more than 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to randomization
a
Fasting glucose <140 mg/dL and HbA1C <8% and T2DM not requiring insulin allowed.
b
ET for protocol-defined endocrine sensitive disease = AI, ET for protocol-defined endocrine resistant disease = fulvestrant.
c
HbA1C <8% and T2DM not requiring insulin allowed.
For information on trial enrollment, locations, and more, call 1-800-545-5979.
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