A Study of Abemaciclib (LY2835219) In Participants With Previously Treated Breast Cancer That Has Spread
- Registration Number
- NCT02102490
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
The main purpose of this study is to evaluate whether the study drug known as abemaciclib is effective in treating participants with breast cancer who have already tried other drug treatments.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 132
Not provided
- Have either a history of central nervous system (CNS) metastasis or evidence of CNS metastasis on the magnetic resonance image of brain obtained at baseline.
- Received prior therapy with another cyclin-dependent kinases 4 and 6 (CDK4/6) inhibitor.
- Have received treatment with a drug that has not received regulatory approval for any indication within 14 or 21 days of the initial dose of study drug.
- Have had major surgery within 14 days of the initial dose of study drug.
- Have a history of any other cancer (except non-melanoma skin cancer or carcinoma in-situ of the cervix).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Abemaciclib Abemaciclib 200 milligrams (mg) abemaciclib given orally once every 12 hours for 28 days (1 cycle). Participants may continue to receive treatment until discontinuation criteria are met.
- Primary Outcome Measures
Name Time Method Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Objective Response Rate [ORR]) From Date of First Dose until Disease Progression or Death Due to Any Cause (Up To 14 Months) ORR was the percentage of participants achieving a best overall response (BOR) of complete response (CR) or partial response (PR) as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. CR defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR defined as at least a 30% decrease in the sum of the longest diameters (LD) of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions.
- Secondary Outcome Measures
Name Time Method Duration of Response (DOR) From Date of CR, PR until Disease Progression or Death Due to Any Cause (Up To 14 Months) DOR was the time from the date of first evidence of complete response or partial response to the date of objective progression or the date of death due to any cause, whichever is earlier. CR and PR were defined using the RECIST v1.1. CR defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR defined as at least a 30% decrease in the sum of the LD of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. If a responder was not known to have died or have objective progression as of the data inclusion cutoff date, duration of response was censored at the last adequate tumor assessment date.
Overall Survival (OS) From Date of First Dose until Death Due to Any Cause (Up To 27 Months) OS defined as the time from first dose date to the date of death due to any cause. For each participant who is not known to have died as of the data-inclusion cutoff date for overall survival analysis, OS time was censored on the last date the participant is known to be alive.
Number of Participants With Categorical Change From Baseline in Brief Pain Inventory Short Form (mBPI-sf) - Worst Pain Score Cycle 6 Day 1 A self-reported scale that measures the severity of pain based on the average pain experienced over the past 24 hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).
Percentage of Participants With CR, PR or SD (Disease Control Rate [DCR]) From Date of First Dose until Disease Progression or Death Due to Any Cause (Up To 14 Months) Disease Control Rate (DCR) was the percentage of participants with a best overall response of CR, PR, or Stable Disease (SD) as per Response using RECIST v1.1 criteria. CR defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR defined as at least a 30% decrease in the sum of the LD of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. SD was neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD for target lesions, no progression of non-target lesions, and no appearance of new lesions.
Progression Free Survival (PFS) From Date of First Dose until Disease Progression or Death Due to Any Cause (Up To 27 Months) PFS defined as the time from the first day of therapy to the first evidence of disease progression as defined by RECIST v1.1 or death from any cause. Progressive Disease (PD) was at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. If a participant does not have a complete baseline disease assessment, then the PFS time was censored at the date of first dose, regardless of whether or not objectively determined disease progression or death has been observed for the participant. If a participant was not known to have died or have objective progression as of the data inclusion cutoff date for the analysis, the PFS time was censored at the last adequate tumor assessment date.
Percentage of Participants With Tumor Response of Stable Disease (SD) for at Least 6 Months, Partial Response (PR) or Complete Response (CR) (Clinical Benefit Rate) From Date of First Dose until Disease Progression or Death Due to Any Cause (Up To 14 Months) Clinical benefit rate defined as percentage of patients with best overall response of CR, PR, or SD with a duration of at least 6 months. CR, PR, or SD were defined using RECIST, v1.1 criteria. CR defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR defined as at least a 30% decrease in the sum of the LD of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. SD was neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD for target lesions, no progression of non-target lesions, and no appearance of new lesions. Percentage of participants = (participants with CR+PR+SD with a duration of at least 6 months /number of participants enrolled) \*100.
Pharmacokinetics: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) for Abemaciclib and Metabolites M2 and M20 Cycle 1 Day 1 pre dose, Cycle 1 Day 15 4 hours (h) and 7 h post dose, Cycle 2 Day 1 pre dose and 3 h post dose, Cycle 3 Day1 pre dose Area Under the Concentration versus Time Curve from Time Zero to Infinity (AUC\[0-∞\]) was evaluated for Abemaciclib and Metabolites M2 and M20
Number of Participants With Categorical Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) - Global Health Status Score Cycle 6 Day 1 EORTC QLQ-C30 v3.0 was a self-administered questionnaire with multidimensional scales that measures 5 functional domains (physical, role, cognitive, emotional, and social), global health status, and symptom scales of fatigue, pain, nausea and vomiting, dyspnea, loss of appetite, insomnia, constipation and diarrhea, and financial difficulties. A linear transformation is applied to standardize the raw scores to range between 0 and 100 per developer guidelines. For functional domains and global health status, higher scores represent a better level of functioning. For symptoms scales, higher scores represented a greater degree of symptoms.
Trial Locations
- Locations (27)
Texas Oncology-Plano West
🇺🇸Plano, Texas, United States
Northwest Cancer Specialists PC
🇺🇸Vancouver, Washington, United States
Univ of California San Francisco
🇺🇸San Francisco, California, United States
Sansum Medical Research Foundation
🇺🇸Santa Barbara, California, United States
Rocky Mountain Cancer Center
🇺🇸Denver, Colorado, United States
Memorial Sloan Kettering Cancer Center
🇺🇸New York, New York, United States
Minnesota Oncology/Hematology PA
🇺🇸Minneapolis, Minnesota, United States
Oncology Hematology Care Inc
🇺🇸Cincinnati, Ohio, United States
Sarah Cannon Research Institute SCRI
🇺🇸Nashville, Tennessee, United States
Texas Oncology Cancer Center
🇺🇸Austin, Texas, United States
Texas Oncology - Bedford
🇺🇸Bedford, Texas, United States
Presbyterian Hospital Dallas
🇺🇸Dallas, Texas, United States
Texas Oncology-Baylor Charles A. Sammons Cancer Center
🇺🇸Dallas, Texas, United States
The Center for Cancer and Blood Disorders
🇺🇸Fort Worth, Texas, United States
Texas Oncology-Memorial City
🇺🇸Houston, Texas, United States
Texas Oncology-Sherman
🇺🇸Sherman, Texas, United States
US Oncology
🇺🇸The Woodlands, Texas, United States
Tyler Cancer Center
🇺🇸Tyler, Texas, United States
Northern Arizona Hematology & Oncology Associates
🇺🇸Sedona, Arizona, United States
Florida Cancer Specialists
🇺🇸Saint Petersburg, Florida, United States
Arizona Clinical Research Center
🇺🇸Tucson, Arizona, United States
Washington Hospital Center
🇺🇸Washington, District of Columbia, United States
HOPE Hematology Oncology Physicians and Extenders
🇺🇸Tucson, Arizona, United States
Advanced Medical Specialties
🇺🇸Miami, Florida, United States
Maryland Oncology Hematology, P.A.
🇺🇸Columbia, Maryland, United States
Dana Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
🇪🇸Valencia, Spain