Study Stopped
Business decision based on the inability to enroll subjects into the trial
A Study of Abemaciclib (LY2835219) in Combination With Fulvestrant Compared to Chemotherapy in Women With HR Positive, HER2 Negative Metastatic Breast Cancer
A Multicenter, Open-Label, Randomized-Controlled Study of Abemaciclib, a CDK4 and 6 Inhibitor, in Combination With Fulvestrant Compared to Chemotherapy in Women With HR Positive, HER2 Negative Metastatic Breast Cancer With Visceral Metastases
2 other identifiers
interventional
4
2 countries
61
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Aug 2019
Shorter than P25 for phase_4
61 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 23, 2019
CompletedFirst Posted
Study publicly available on registry
July 24, 2019
CompletedStudy Start
First participant enrolled
August 14, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 11, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
August 11, 2020
CompletedResults Posted
Study results publicly available
August 24, 2021
CompletedAugust 24, 2021
July 1, 2021
12 months
July 23, 2019
July 29, 2021
July 29, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
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.
Randomization to Measured Progressive Disease (Up to 12 Months)
Secondary Outcomes (4)
Progression Free Survival (PFS)
First Dose Date to Objective Progression or Death Due to Any Cause (Up to 12 Months)
Time to Response (TTR)
First Dose to Date of CR or PR (Up to 12 Months)
Duration of Response (DoR)
Date of CR or PR to Date of Objective Progression or Death Due to Any Cause (Up to 12 Months)
Progression Free Survival 2 (PFS 2)
Randomization to Second Objective Progression or Death Due to Any Cause (Up to 12 Months)
Study Arms (2)
Abemaciclib + Fulvestrant
EXPERIMENTAL150 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
ACTIVE COMPARATORStandard chemotherapy of physician's choice (capecitabine, docetaxel, nab paclitaxel, or paclitaxel), administered according to product label.
Interventions
Standard chemotherapy of physician's choice administered according to product label.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (61)
Scottsdale Healthcare Hospitals
Avondale, Arizona, 85392, United States
University of Arizona Cancer Center
Phoenix, Arizona, 85004, United States
Yuma Regional Cancer Center
Yuma, Arizona, 85364, United States
CARTI Cancer Center
Little Rock, Arkansas, 72205, United States
Comprehensive Blood and Cancer Center
Bakersfield, California, 93309, United States
Compassionate Cancer Care Medical Group Inc
Corona, California, 92879, United States
Chan Soon- Shiong Institute for Medicine
Costa Mesa, California, 92627, United States
Chan Soon- Shiong Institute for Medicine
El Segundo, California, 90245, United States
Compassionate Cancer Care Medical Group Inc
Fountain Valley, California, 92708, United States
St. Joseph Heritage Healthcare
Fullerton, California, 92835, United States
Scripps Clinic
La Jolla, California, 92037, United States
UCLA Medical Center
Los Angeles, California, 90024, United States
TRIO - Translational Research in Oncology-US, Inc.
Los Angeles, California, 90095, United States
Univ of California Irvine College of Medicine
Orange, California, 92868, United States
Comprehensive Cancer Centers of the Desert
Palm Springs, California, 92262, United States
Desert Hematology Oncology Medical Group
Rancho Mirage, California, 92270, United States
Emad Ibrahim, MD, INC
Redlands, California, 92373, United States
Compassionate Cancer Care Medical Group Inc
Riverside, California, 92501, United States
University of California, Davis - Health Systems
Sacramento, California, 95864, United States
Torrance Memorial Medical Center
Torrance, California, 90505, United States
Banner MD Anderson Cancer Center
Greeley, Colorado, 80631, United States
Hartford Hospital
Hartford, Connecticut, 06102-5037, United States
Millennium Oncology
Hollywood, Florida, 33024, United States
Ocala Oncology, P.A.
Ocala, Florida, 34474, United States
Tallahassee Memorial Cancer Center
Tallahassee, Florida, 32308, United States
Cleveland Clinic of Florida
Weston, Florida, 33331, United States
Candler Medical Oncology Practice
Savannah, Georgia, 31405, United States
Tift Regional Health System Anita Stewart Oncology Center
Tifton, Georgia, 31794, United States
Kaiser Permanente Center for Health Research
Honolulu, Hawaii, 96819, United States
Saint Alphonsus Regional Medical Center
Boise, Idaho, 83706, United States
Cancer Center of Kansas
Wichita, Kansas, 67214, United States
Touro Infirmary
New Orleans, Louisiana, 70115, United States
Willis-Knighton Cancer Center
Shreveport, Louisiana, 71103, United States
York Hospital
York Village, Maine, 03909, United States
Reliant Medical Group, Inc.
Worcester, Massachusetts, 01608, United States
Karmanos Cancer Institute
Detroit, Michigan, 48201, United States
Baptist Cancer Center
Oxford, Mississippi, 38655, United States
St. Francis Medical Center
Grand Island, Nebraska, 68803, United States
Oncology Hematology West
Omaha, Nebraska, 68130, United States
OptumCare Cancer Care
Las Vegas, Nevada, 89102, United States
Carol Simon Cancer Center at Overlook Medical Center
Summit, New Jersey, 07901, United States
Brooklyn Methodist Hospital
Brooklyn, New York, 11215, United States
Weill Cornell Medical College
New York, New York, 10065, United States
SUNY At Stony Brook
Stony Brook, New York, 11794, United States
White Plains Hospital
White Plains, New York, 10601, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106, United States
Cancer Care Associates of York
York, Pennsylvania, 17403, United States
Womens and Infants
Providence, Rhode Island, 02905, United States
Baptist Cancer Center
Memphis, Tennessee, 38120, United States
The Center for Cancer and Blood Disorders
Fort Worth, Texas, 76104, United States
Oncology Consultants, P.A.
Houston, Texas, 77030, United States
Renovatio Clinical
The Woodlands, Texas, 77380, United States
University of Vermont Medical Center
Burlington, Vermont, 05401, United States
Providence Regional Cancer Partnership
Everett, Washington, 98201, United States
Cancer Care Northwest
Spokane, Washington, 99202, United States
Centro Integrado de Cancer del Sur, PSC
Coto Laurel, PR, 00780, Puerto Rico
Bella Vista Oncology Group
Mayagüez, PR, 00680, Puerto Rico
Ponce Medical School
Ponce, PR, 00716, Puerto Rico
Centro de Cancer de la Mujer
Ponce, PR, 00717, Puerto Rico
Fundacion de Investigacion de Diego
San Juan, PR, 00927, Puerto Rico
Clinical Research Puerto Rico, Inc.
San Juan, 00909, Puerto Rico
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
This study was terminated early as a business decision based on the inability to enroll subjects into the trial.
Results Point of Contact
- Title
- Chief Medical Officer
- Organization
- Eli Lilly and Company
Study Officials
- STUDY DIRECTOR
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Eli Lilly and Company
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
- Expanded Access
- Yes
Study Record Dates
First Submitted
July 23, 2019
First Posted
July 24, 2019
Study Start
August 14, 2019
Primary Completion
August 11, 2020
Study Completion
August 11, 2020
Last Updated
August 24, 2021
Results First Posted
August 24, 2021
Record last verified: 2021-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
- Access Criteria
- A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.