A Study of Abemaciclib (LY2835219) in Combination With Fulvestrant Compared to Chemotherapy in Women With HR Positive, HER2 Negative Metastatic Breast Cancer
- Conditions
- Metastatic Breast Cancer
- Interventions
- Registration Number
- NCT04031885
- Lead Sponsor
- Eli Lilly and Company
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Female
- Target Recruitment
- 4
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Abemaciclib + Fulvestrant Abemaciclib 150 milligram (mg) Abemaciclib given orally twice a day (BID) with 500 mg fulvestrant given by intramuscular (IM) injection on Cycle 1 Day 1 (C1D1) and Cycle 1 Day 15 (C1D15), then Day 1 of each subsequent cycle. Standard Chemotherapy Standard Chemotherapy Standard chemotherapy of physician's choice (capecitabine, docetaxel, nab paclitaxel, or paclitaxel), administered according to product label. Abemaciclib + Fulvestrant Fulvestrant 150 milligram (mg) Abemaciclib given orally twice a day (BID) with 500 mg fulvestrant given by intramuscular (IM) injection on Cycle 1 Day 1 (C1D1) and Cycle 1 Day 15 (C1D15), then Day 1 of each subsequent cycle.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
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.
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.
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.
Trial Locations
- Locations (57)
Scottsdale Healthcare Hospitals
🇺🇸Avondale, Arizona, United States
University of Arizona Cancer Center
🇺🇸Phoenix, Arizona, United States
Yuma Regional Cancer Center
🇺🇸Yuma, Arizona, United States
CARTI Cancer Center
🇺🇸Little Rock, Arkansas, United States
Comprehensive Blood and Cancer Center
🇺🇸Bakersfield, California, United States
Compassionate Cancer Care Medical Group Inc
🇺🇸Riverside, California, United States
Chan Soon- Shiong Institute for Medicine
🇺🇸El Segundo, California, United States
St. Joseph Heritage Healthcare
🇺🇸Fullerton, California, United States
Scripps Clinic
🇺🇸La Jolla, California, United States
UCLA Medical Center
🇺🇸Los Angeles, California, United States
Scroll for more (47 remaining)Scottsdale Healthcare Hospitals🇺🇸Avondale, Arizona, United States