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PIPELINE > TRIAL OVERVIEW

Trial Information
Molecule Overview
CDK4/6 Inhibitor
Abemaciclib
Phase
3
Not Enrolling
A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Compare the Efficacy of Abemaciclib Plus Fulvestrant to Placebo Plus Fulvestrant in Participants With HR+, HER2-, Advanced or Metastatic Breast Cancer Following Progression on a CDK4 & 6 Inhibitor and Endocrine Therapy*
Related Resources:
Molecule Overview Trial Enrollment
NCT05169567 show modal icon
Key Inclusion Criteria
  • Hormone-receptor-positive (HR+), HER2-negative (HER2-) locally advanced or metastatic breast cancer
  • Radiologic evidence of disease progression or recurrence either:
    • On treatment with a cyclin-dependent kinase 4 and 6 (CDK4/6) with aromatase inhibitor (AI) as initial therapy for advanced disease, or
    • On/after treatment with a CDK4/6 inhibitor plus endocrine therapy (ET) administered as adjuvant therapy for early-stage breast cancer
  • Must be deemed appropriate for treatment with ET
  • If female, have a postmenopausal status by natural or surgical means or by ovarian function suppression
  • Measurable disease and/or nonmeasurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Adequate renal, hematologic, and hepatic organ function
  • Able to swallow capsules/tablets
Key Exclusion Criteria
  • Visceral crisis, lymphangitic spread, or leptomeningeal carcinomatosis
  • Symptomatic or untreated central nervous system metastasis
  • Received any systemic therapy between disease recurrence/progression and study screening
  • Received more than one line of therapy for advanced or metastatic disease
  • Prior chemotherapy for metastatic breast cancer (MBC)
  • Prior treatment with fulvestrant, any investigational estrogen receptor (ER)-directed therapy (including selective ER degraders [SERDs] and non-SERDs), any PI3K, mTOR, or AKT inhibitor
*
This clinical trial is being conducted globally.
†
Abemaciclib or placebo equivalent is administered PO.
‡
Fulvestrant is administered intramuscularly.
For information on trial enrollment, locations, and more, call 1-800-545-5979.
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or visit www.clinicaltrials.gov for more information on this trial