Overview

This trial is active, not recruiting.

Condition breast cancer
Treatments abemaciclib, anastrozole, letrozole, placebo
Phase phase 3
Target CDK4
Sponsor Eli Lilly and Company
Start date November 2014
End date June 2017
Trial size 450 participants
Trial identifier NCT02246621, 15417, 2014-001502-18, I3Y-MC-JPBM

Summary

The main purpose of this study is to evaluate how effective nonsteroidal aromatase inhibitors (NSAI) plus abemaciclib are in postmenopausal women with breast cancer. Participants will be randomized to abemaciclib or placebo in a 2:1 ratio.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver)
Primary purpose treatment
Arm
(Experimental)
150 milligrams (mg) Abemaciclib orally every 12 hours plus either 1 mg anastrozole or 2.5 mg letrozole orally once daily for 28 days (28 day cycles).
abemaciclib LY2835219
Administered orally
anastrozole
Administered orally
letrozole
Administered orally
(Placebo Comparator)
Placebo orally every 12 hours plus either 1 mg anastrozole or 2.5 mg letrozole orally once daily for 28 days (28 day cycles).
anastrozole
Administered orally
letrozole
Administered orally
placebo
Administered orally

Primary Outcomes

Measure
Progression Free Survival (PFS)
time frame: Baseline up to Measured Progressive Disease or Death from Any Cause (Approximately 34 Months)

Secondary Outcomes

Measure
Overall Survival (OS)
time frame: Baseline to Date of Death from Any Cause (Approximately 82 Months)
Duration of Response (DoR)
time frame: Date of Complete Response (CR) or Partial Response (PR) to Date of Objective Disease Progression or Death Due to Any Cause (Estimated up to 34 Months)
Disease Control Rate (DCR)
time frame: Baseline to Disease Progression (Approximately 34 Months)
Clinical Benefit Rate (CBR)
time frame: Baseline to Disease Progression (Approximately 34 Months)
Change from Baseline to End of Study in Symptom Burden on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)
time frame: Baseline, End of Study (up to 34 Months)
Change from Baseline to End of Study in Symptom Burden on the EORTC QLQ-Breast23 Questionnaire
time frame: Baseline, End of Study (up to 34 Months)
Change from Baseline to End of Study in Health Status on the EuroQuol 5-Dimension 5 Level (EuroQol-5D 5L)
time frame: Baseline, End of Study (up to 34 Months)
Pharmacokinetics (PK): Volume of Distribution of Abemaciclib, its Metabolites, and NSAI Therapy
time frame: Cycle 1 Postdose through Cycle 4 (Approximately 4 Months)
Objective Response Rate (ORR)
time frame: Baseline to Disease Progression (Approximately 34 Months)
PK: Clearance of Abemaciclib, its Metabolites, and NSAI Therapy
time frame: Cyle 1 Postdose through Cycle 4 (Approximately 4 Months)

Eligibility Criteria

Female participants at least 18 years old.

Inclusion Criteria: - Have a diagnosis of hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer - Have locoregionally recurrent disease not amenable to resection or radiation therapy with curative intent or metastatic disease - Have postmenopausal status - Have either measurable disease or nonmeasurable bone-only disease - Have a performance status ≤1 on the Eastern Cooperative Oncology Group (ECOG) scale - Have adequate organ function - Have discontinued previous localized radiotherapy for palliative purposes or for lytic lesions at risk of fracture prior to randomization and recovered from the acute effects of therapy - Are able to swallow capsules Exclusion Criteria: - Have visceral crisis, lymphangitic spread, or leptomeningeal carcinomatosis - Have inflammatory breast cancer - Have clinical evidence or a history of central nervous system (CNS) metastasis - Are currently receiving or have previously received endocrine therapy for locoregionally recurrent or metastatic breast cancer - Have received prior (neo)adjuvant endocrine therapy with a disease-free interval ≤12 months from completion of treatment - Are currently receiving or have previously received chemotherapy for locoregionally recurrent or metastatic breast cancer - Have received prior treatment with everolimus - Have received prior treatment with any cyclin-dependent kinase (CDK) 4/6 inhibitor (or participated in any CDK4/6 inhibitor clinical trial for which treatment assignment is still blinded) - Have initiated bisphosphonates or approved receptor activator of nuclear factor kappa-B ligand (RANK-L) targeted agents <7 days prior to randomization - Are currently receiving an investigational drug in a clinical trial or participating in any other type of medical research judged not to be scientifically or medically compatible with this study - Have received treatment with a drug that has not received regulatory approval for any indication within 14 or 21 days of randomization for a nonmyelosuppressive or myelosuppressive agent, respectively - Have had major surgery within 14 days prior to randomization

Additional Information

Official title A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study of Nonsteroidal Aromatase Inhibitors (Anastrozole or Letrozole) Plus LY2835219, a CDK4/6 Inhibitor, or Placebo in Postmenopausal Women With Hormone Receptor-Positive, HER2-Negative Locoregionally Recurrent or Metastatic Breast Cancer With No Prior Systemic Therapy in This Disease Setting
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Eli Lilly and Company.