Clinical Trials /

A Study of Abemaciclib (LY2835219) in Participants With HR+, HER2- Advanced Breast Cancer

NCT03988114

Description:

The reason for this study is to see if the drug abemaciclib in combination with nonsteroidal aromatase inhibitors (anastrozole or letrozole) is effective in participants with Hormone Receptor Positive (HR+), Human Epidermal Growth Factor Receptor 2 Negative (HER2-) advanced breast cancer that have certain disease characteristics.

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Withdrawn

Phase:

Phase 4

Trial Eligibility

Document

Title

  • Brief Title: A Study of Abemaciclib (LY2835219) in Participants With HR+, HER2- Advanced Breast Cancer
  • Official Title: A Single-Arm, Global, Phase 4 Study of Abemaciclib, a CDK 4 & 6 Inhibitor, in Combination With Nonsteroidal Aromatase Inhibitors (Anastrozole or Letrozole) in Participants With Hormone Receptor Positive, Human Epidermal Growth Factor Receptor 2 Negative Advanced Breast Cancer With Poor Prognostic Factors

Clinical Trial IDs

  • ORG STUDY ID: 17395
  • SECONDARY ID: I3Y-MC-JPCX
  • SECONDARY ID: 2019-001781-16
  • NCT ID: NCT03988114

Conditions

  • Metastatic Breast Cancer

Interventions

DrugSynonymsArms
AbemaciclibLY2835219Abemaciclib + NSAI
Nonsteroidal Aromatase Inhibitor (NSAI)Abemaciclib + NSAI

Purpose

The reason for this study is to see if the drug abemaciclib in combination with nonsteroidal aromatase inhibitors (anastrozole or letrozole) is effective in participants with Hormone Receptor Positive (HR+), Human Epidermal Growth Factor Receptor 2 Negative (HER2-) advanced breast cancer that have certain disease characteristics.

Trial Arms

NameTypeDescriptionInterventions
Abemaciclib + NSAIExperimentalAbemaciclib given orally and nonsteroidal aromatase inhibitor (NSAI) of physician's choice (anastrazole or letrozole) given orally.
  • Abemaciclib
  • Nonsteroidal Aromatase Inhibitor (NSAI)

Eligibility Criteria

        Inclusion Criteria:

          -  Participants must have completed (neo) adjuvant endocrine therapy and have cancer
             return after at least 12 months or have de novo cancer that has spread to other organs
             at diagnosis

          -  Participants must have 1 or more of the following:

               -  A high grade tumor in tissue

               -  Negative progesterone receptor (PR) status

               -  Have cancer that has spread to the liver

               -  Have a treatment-free interval (TFI) <36 months

          -  Participants must have HR+, HER2- breast cancer

          -  Participants must have adequate organ function

        Exclusion Criteria:

          -  Participants must not have cancer that has spread to other organs that has severely
             affected their function

          -  Participants must not have cancer that has spread to the brain that is unstable or
             untreated

          -  Participants must not have received endocrine therapy in the metastatic setting

          -  Participants must not have known active infection

          -  Participants must not have received prior endocrine therapy and had disease return
             within 12 months from completion of treatment

          -  Participants must not have received prior treatment with any cyclin-dependent kinase
             (CDK) 4 & 6 inhibitor or everolimus
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Progression Free Survival (PFS)
Time Frame:Baseline to Progressive Disease or Death from Any Cause (Estimated up to 26 Months)
Safety Issue:
Description:PFS

Secondary Outcome Measures

Measure:Duration of Response (DoR)
Time Frame:Date of CR or PR to Date of Objective Disease Progression or Death from Any Cause (Estimated up to 26 Months)
Safety Issue:
Description:DoR
Measure:Disease Control Rate (DCR): Percentage of Participants with a Best Overall Response of CR, PR, or Stable Disease (SD)
Time Frame:Baseline to Objective Disease Progression (Estimated up to 26 Months)
Safety Issue:
Description:DCR
Measure:Clinical Benefit Rate (CBR): Proportion of Participants with Best Overall Response of CR, PR, or SD with Duration of SD for at Least 6 Months
Time Frame:Date of CR, PR or SD to 6 Months Post CR, PR or SD (Estimated up to 26 Months)
Safety Issue:
Description:CBR
Measure:Time to Response (TTR)
Time Frame:Baseline to Date of CR or PR (Estimated up to 26 Months)
Safety Issue:
Description:TTR

Details

Phase:Phase 4
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Eli Lilly and Company

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