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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Administered orally
Letrozole administered orally or anastrozole administered orally (physician choice)
Progression Free Survival (PFS)
PFS
Time frame: 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
Time frame: Baseline to Objective Disease Progression (Estimated up to 26 Months)
Duration of Response (DoR)
DoR
Time frame: 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
Time frame: 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
Time frame: Date of CR, PR or SD to 6 Months Post CR, PR or SD (Estimated up to 26 Months)
Time to Response (TTR)
TTR
Time frame: Baseline to Date of CR or PR (Estimated up to 26 Months)
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