Metastatic Breast Cancer
Conditions
Brief summary
The reason for this study is to compare the efficacy of abemaciclib, in combination with fulvestrant, to that of physician's choice of chemotherapy in women with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) metastatic breast cancer that has spread to internal organs. Your participation in this trial could last up to 31 months, depending on your cancer type and how you and your tumor respond.
Interventions
DRUGAbemaciclib
Administered orally
DRUGFulvestrant
Administered IM
DRUGStandard Chemotherapy
Standard chemotherapy of physician's choice administered according to product label.
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participants must be females of post-menopausal status with HR+, HER2- breast cancer that has spread to internal organs * Participants must have had at least one endocrine therapy * Participants must be willing to use a device to answer daily questions about how they are doing for the duration of their participation in the study * If participant has diarrhea from a previous treatment, they should talk to their doctor to ensure they have recovered enough to participate in this study
Exclusion criteria
* Participants must not have breast cancer that has spread to the brain if untreated and with symptoms * Participants must not have had any systemic treatment after their breast cancer has spread unless it is endocrine therapy * Participants must not have certain active infections including HIV or hepatitis * Participants must not be pregnant or breastfeeding * Participants must not have certain types of cancers or certain previous cancer treatments * Participants must not have certain serious medical conditions, including heart or lung disease, or have had certain types of tissue or organ transplants
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate (ORR): Percentage of Participants Who Achieve Complete Response (CR) or Partial Response (PR) | Randomization to Measured Progressive Disease (Up to 12 Months) | ORR is defined as the number of participants who achieve a best overall response (BOR) of complete response (CR) or partial response (PR) divided by the total number of participants randomized to the corresponding treatment arm \[intent-to-treat (ITT) population\], based on investigator-assessed tumor responses.CR is defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR is defined as at least a 30% decrease in the sum of the longest diameters (LD) of target lesions (taking in reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. Confirmations of CR and PR are not required. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression Free Survival (PFS) | First Dose Date to Objective Progression or Death Due to Any Cause (Up to 12 Months) | PFS is defined as the time from first dose date until the first occurrence of documented disease progression per Response Criteria In Solid Tumors version 1.1(RECIST v1.1) or death from any cause in the absence of progressive disease. Progression-free survival will be based on investigator-assessed tumor responses; there will not be an independent central review of imaging data. |
| Time to Response (TTR) | First Dose to Date of CR or PR (Up to 12 Months) | TTR is defined as the time from first dose date until the date that measurement criteria for CR or PR (whichever is first recorded) are first met, per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. |
| Duration of Response (DoR) | Date of CR or PR to Date of Objective Progression or Death Due to Any Cause (Up to 12 Months) | DoR is defined as the time from the date that measurement criteria for CR or PR (whichever is first recorded) are first met until the first date that disease is recurrent or documented disease progression is observed, per RECIST 1.1 criteria, or the date of death from any cause in the absence of documented disease progression or recurrence. |
| Progression Free Survival 2 (PFS 2) | Randomization to Second Objective Progression or Death Due to Any Cause (Up to 12 Months) | PFS 2 is defined as the time from first dose date to the disease progression date on next line (first line of post-discontinuation treatment), or starting date of the second line of post-discontinuation treatment or death from any cause, whichever is earlier, or death from any cause, whichever is earlier. |
Countries
Puerto Rico, United States
Participant flow
Recruitment details
The study was terminated early as a business decision based on the inability to enroll subjects into the trial.
Pre-assignment details
Participants who have had at least one adequate tumor assessment at baseline and post-baseline and are off study treatment are considered to have completed the study.
Participants by arm
| Arm | Count |
|---|---|
| Abemaciclib + Fulvestrant 150 mg Abemaciclib given orally BID with 500 mg fulvestrant given by IM injection on C1D1 and C1D15, then Day 1 of each subsequent cycle. | 1 |
| Standard Chemotherapy Standard chemotherapy of physician's choice (capecitabine, docetaxel, nab paclitaxel, or paclitaxel), administered according to product label. | 3 |
| Total | 4 |
Baseline characteristics
| Characteristic | Standard Chemotherapy | Total | Abemaciclib + Fulvestrant |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 2 Participants | 2 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants | 2 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 3 Participants | 4 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 2 Participants | 3 Participants | 1 Participants |
| Region of Enrollment United States | 3 Participants | 4 Participants | 1 Participants |
| Sex: Female, Male Female | 3 Participants | 4 Participants | 1 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 1 | 1 / 3 |
| other Total, other adverse events | 1 / 1 | 3 / 3 |
| serious Total, serious adverse events | 1 / 1 | 0 / 3 |
Outcome results
Primary
Objective Response Rate (ORR): Percentage of Participants Who Achieve Complete Response (CR) or Partial Response (PR)
ORR is defined as the number of participants who achieve a best overall response (BOR) of complete response (CR) or partial response (PR) divided by the total number of participants randomized to the corresponding treatment arm \[intent-to-treat (ITT) population\], based on investigator-assessed tumor responses.CR is defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR is defined as at least a 30% decrease in the sum of the longest diameters (LD) of target lesions (taking in reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. Confirmations of CR and PR are not required.
Time frame: Randomization to Measured Progressive Disease (Up to 12 Months)
Population: All randomized participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Abemaciclib + Fulvestrant | Objective Response Rate (ORR): Percentage of Participants Who Achieve Complete Response (CR) or Partial Response (PR) | 0 percentage of participants |
| Standard Chemotherapy | Objective Response Rate (ORR): Percentage of Participants Who Achieve Complete Response (CR) or Partial Response (PR) | 0 percentage of participants |
Secondary
Duration of Response (DoR)
DoR is defined as the time from the date that measurement criteria for CR or PR (whichever is first recorded) are first met until the first date that disease is recurrent or documented disease progression is observed, per RECIST 1.1 criteria, or the date of death from any cause in the absence of documented disease progression or recurrence.
Time frame: Date of CR or PR to Date of Objective Progression or Death Due to Any Cause (Up to 12 Months)
Population: Zero participants analyzed, no data collected.
Secondary
Progression Free Survival 2 (PFS 2)
PFS 2 is defined as the time from first dose date to the disease progression date on next line (first line of post-discontinuation treatment), or starting date of the second line of post-discontinuation treatment or death from any cause, whichever is earlier, or death from any cause, whichever is earlier.
Time frame: Randomization to Second Objective Progression or Death Due to Any Cause (Up to 12 Months)
Population: Zero participants analyzed, no data collected.
Secondary
Progression Free Survival (PFS)
PFS is defined as the time from first dose date until the first occurrence of documented disease progression per Response Criteria In Solid Tumors version 1.1(RECIST v1.1) or death from any cause in the absence of progressive disease. Progression-free survival will be based on investigator-assessed tumor responses; there will not be an independent central review of imaging data.
Time frame: First Dose Date to Objective Progression or Death Due to Any Cause (Up to 12 Months)
Population: Zero participants analyzed, no data collected.
Secondary
Time to Response (TTR)
TTR is defined as the time from first dose date until the date that measurement criteria for CR or PR (whichever is first recorded) are first met, per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
Time frame: First Dose to Date of CR or PR (Up to 12 Months)
Population: Zero participants analyzed, no data collected.