Clinical Trial 24096

• Overview

  Study Title:

  An Open-Label, Randomized, Multicenter Phase 3 Study Investigating the Efficacy and Safety of BGB-43395 Plus Letrozole versus CDK4/6 Inhibitors (Abemaciclib, Palbociclib, Ribociclib) Plus Letrozole in Patients with Advanced or Metastatic HR+/HER2- Breast Cancer Who Have Not Received Prior Systemic Anticancer Treatment for Advanced or Metastatic Disease

  Summary:

  The purpose of this study is to investigate the efficacy and safety of BGB-43395 in combination with letrozole compared with investigator's choice of cyclin-dependent kinase 4/6 inhibitor (CDK4/6i) in combination with letrozole in patients with advanced or metastatic hormone receptor positive (HR+)/human epidermal growth factor receptor 2 negative (HER2-) breast cancer (BC) who have not received prior systemic treatment for advanced or metastatic disease.

  Objective:

  Primary Objective: To evaluate the progression-free survival (PFS) for treatment with BGB-43395 plus letrozole (Arm A) compared with cyclin-dependent kinase (CDK) 4/6i plus letrozole (Arm B) in patients with advanced or metastatic HR+/HER2- breast cancer (BC) who have not received prior systemic treatment for advanced or metastatic disease. Secondary Objectives: To compare the overall survival (OS) in Arm A versus Arm B. To further evaluate the anticancer activity of Arm A compared with Arm B. To evaluate the safety of treatment in Arm A compared with Arm B. To evaluate patient-reported disease and treatment-related symptoms in patients in Arm A compared with Arm B.

• Treatments

  Therapies:

  Aromatase Inhibitor; CDK4 inhibitor; CDK4/6 Inhibitor

  Medications:

  772256 (Palbociclib); Abemaciclib (); BGB-43395 (); Femara (Letrozole); LEE011 (Ribociclib); LY2835219 (Abemaciclib); Letrozole (); Palbociclib (); Ribociclib ()

• Inclusion Criteria

  Key Inclusion Criteria:
  • Participants must be at least 18 years of age or the legal age of consent in the jurisdiction in which the study is taking place at the time of signing the informed consent.
  • Participants with histologically confirmed locally advanced or metastatic HR+ HER2- breast cancer.
  • Participants must have a stable Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 1.
  • Adequate organ function.

• Exclusion Criteria

  Key Exclusion Criteria:
  • Participants who have received prior systemic treatment in the advanced or metastatic setting.
  • Participants who have received prior treatment with any selective cyclin-dependent kinase 4 (CDK4) or cyclin-dependent kinase 2 (CDK2) targeting agent, or any other investigational anticancer drug in any disease setting, except for prior investigational or approved SERDs in the adjuvant setting, provided that disease recurrence occurred more than 12 months after the last dose of endocrine-based therapy.
  • Participants with active leptomeningeal disease or uncontrolled, untreated brain metastasis.
  • Other protocol-defined inclusion/exclusion criteria may apply.

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