Clinical Trials /

A Study of Nonsteroidal Aromatase Inhibitors Plus Abemaciclib (LY2835219) in Postmenopausal Women With Breast Cancer

NCT02246621

Description:

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.

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Active, not recruiting

Phase:

Phase 3

Trial Eligibility

Document

Title

  • Brief Title: A Study of Nonsteroidal Aromatase Inhibitors Plus Abemaciclib (LY2835219) in Postmenopausal Women With Breast Cancer
  • 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

Clinical Trial IDs

  • ORG STUDY ID: 15417
  • SECONDARY ID: I3Y-MC-JPBM
  • SECONDARY ID: 2014-001502-18
  • NCT ID: NCT02246621

Conditions

  • Breast Cancer

Interventions

DrugSynonymsArms
AbemaciclibLY2835219Abemaciclib + NSAI
AnastrozoleAbemaciclib + NSAI
LetrozoleAbemaciclib + NSAI
PlaceboPlacebo + NSAI

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
Abemaciclib + NSAIExperimental150 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
  • Anastrozole
  • Letrozole
Placebo + NSAIPlacebo ComparatorPlacebo orally every 12 hours plus either 1 mg anastrozole or 2.5 mg letrozole orally once daily for 28 days (28 day cycles).
  • Anastrozole
  • Letrozole
  • Placebo

Eligibility Criteria

        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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:Female
Healthy Volunteers:No

Primary Outcome Measures

Measure:Progression Free Survival (PFS)
Time Frame:Baseline up to Measured Progressive Disease or Death from Any Cause (Approximately 34 Months)
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Overall Survival (OS)
Time Frame:Baseline to Date of Death from Any Cause (Approximately 82 Months)
Safety Issue:
Description:
Measure: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)
Safety Issue:
Description:
Measure:Disease Control Rate (DCR)
Time Frame:Baseline to Disease Progression (Approximately 34 Months)
Safety Issue:
Description:
Measure:Clinical Benefit Rate (CBR)
Time Frame:Baseline to Disease Progression (Approximately 34 Months)
Safety Issue:
Description:
Measure: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)
Safety Issue:
Description:
Measure: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)
Safety Issue:
Description:
Measure: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)
Safety Issue:
Description:
Measure:Pharmacokinetics (PK): Volume of Distribution of Abemaciclib, its Metabolites, and NSAI Therapy
Time Frame:Cycle 1 Postdose through Cycle 4 (Approximately 4 Months)
Safety Issue:
Description:
Measure:Objective Response Rate (ORR)
Time Frame:Baseline to Disease Progression (Approximately 34 Months)
Safety Issue:
Description:
Measure:PK: Clearance of Abemaciclib, its Metabolites, and NSAI Therapy
Time Frame:Cyle 1 Postdose through Cycle 4 (Approximately 4 Months)
Safety Issue:
Description:

Details

Phase:Phase 3
Primary Purpose:Interventional
Overall Status:Active, not recruiting
Lead Sponsor:Eli Lilly and Company

Trial Keywords

  • MONARCH 3

Last Updated

June 14, 2017