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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Metastatic Breast Cancer

Intervention / Treatment
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* Drug: Abemaciclib
* Drug: Nonsteroidal Aromatase Inhibitor (NSAI)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Abemaciclib + NSAI<br>Abemaciclib given orally and nonsteroidal aromatase inhibitor (NSAI) of physician's choice (anastrazole or letrozole) given orally. | Drug: Abemaciclib<br>* Administered orally<br>* Other names: LY2835219;Drug: Nonsteroidal Aromatase Inhibitor (NSAI)<br>* Letrozole administered orally or anastrozole administered orally (physician choice)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression Free Survival (PFS) | PFS | Baseline to Progressive Disease or Death from Any Cause (Estimated up to 26 Months) | 
| Objective Response Rate (ORR): Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR) | ORR | Baseline to Objective Disease Progression (Estimated up to 26 Months) | 

Secondary Outcome Measures

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