Metastatic Breast Cancer
Conditions
Brief summary
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.
Interventions
DRUGAbemaciclib
Administered orally
Letrozole administered orally or anastrozole administered orally (physician choice)
Sponsors
Eli Lilly and Company
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate (ORR): Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR) | Baseline to Objective Disease Progression (Estimated up to 26 Months) | ORR |
| Progression Free Survival (PFS) | Baseline to Progressive Disease or Death from Any Cause (Estimated up to 26 Months) | PFS |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of Response (DoR) | Date of CR or PR to Date of Objective Disease Progression or Death from Any Cause (Estimated up to 26 Months) | DoR |
| Disease Control Rate (DCR): Percentage of Participants with a Best Overall Response of CR, PR, or Stable Disease (SD) | Baseline to Objective Disease Progression (Estimated up to 26 Months) | DCR |
| 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 | Date of CR, PR or SD to 6 Months Post CR, PR or SD (Estimated up to 26 Months) | CBR |
| Time to Response (TTR) | Baseline to Date of CR or PR (Estimated up to 26 Months) | TTR |
Countries
Argentina, Austria, Belgium, Brazil, Germany, Italy, Puerto Rico, Taiwan, United States
Outcome results
None listed