Clinical trial NCT04031885: A Study of Abemaciclib (LY2835219) in Combination With Fulvestrant Compared to Chemotherapy in Women With HR Positive, HER2 Negative Metastatic Breast Cancer
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Metastatic Breast Cancer
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2019-07-24
Enrollment: 4
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Objective Response Rate (ORR): Percentage of Participants Who Achieve Complete Response (CR) or Partial Response (PR)
timeFrame: Randomization to Measured Progressive Disease (Up to 12 Months)
Secondary outcomes:
measure: Progression Free Survival (PFS)
timeFrame: First Dose Date to Objective Progression or Death Due to Any Cause (Up to 12 Months)
measure: Time to Response (TTR)
timeFrame: First Dose to Date of CR or PR (Up to 12 Months)
measure: Duration of Response (DoR)
timeFrame: Date of CR or PR to Date of Objective Progression or Death Due to Any Cause (Up to 12 Months)
measure: Progression Free Survival 2 (PFS 2)
timeFrame: Randomization to Second Objective Progression or Death Due to Any Cause (Up to 12 Months)
Other outcomes:
Locations:
city: Avondale
country: United States
facility: Scottsdale Healthcare Hospitals
state: Arizona
city: Phoenix
country: United States
facility: University of Arizona Cancer Center
state: Arizona
city: Yuma
country: United States
facility: Yuma Regional Cancer Center
state: Arizona
city: Little Rock
country: United States
facility: CARTI Cancer Center
state: Arkansas
city: Bakersfield
country: United States
facility: Comprehensive Blood and Cancer Center
state: California
city: Corona
country: United States
facility: Compassionate Cancer Care Medical Group Inc
state: California
city: Costa Mesa
country: United States
facility: Chan Soon- Shiong Institute for Medicine
state: California
city: El Segundo
country: United States
facility: Chan Soon- Shiong Institute for Medicine
state: California
city: Fountain Valley
country: United States
facility: Compassionate Cancer Care Medical Group Inc
state: California
city: Fullerton
country: United States
facility: St. Joseph Heritage Healthcare
state: California
city: La Jolla
country: United States
facility: Scripps Clinic
state: California
city: Los Angeles
country: United States
facility: UCLA Medical Center
state: California
city: Los Angeles
country: United States
facility: TRIO - Translational Research in Oncology-US, Inc.
state: California
city: Orange
country: United States
facility: Univ of California Irvine College of Medicine
state: California
city: Palm Springs
country: United States
facility: Comprehensive Cancer Centers of the Desert
state: California
city: Rancho Mirage
country: United States
facility: Desert Hematology Oncology Medical Group
state: California
city: Redlands
country: United States
facility: Emad Ibrahim, MD, INC
state: California
city: Riverside
country: United States
facility: Compassionate Cancer Care Medical Group Inc
state: California
city: Sacramento
country: United States
facility: University of California, Davis - Health Systems
state: California
city: Torrance
country: United States
facility: Torrance Memorial Medical Center
state: California
city: Greeley
country: United States
facility: Banner MD Anderson Cancer Center
state: Colorado
city: Hartford
country: United States
facility: Hartford Hospital
state: Connecticut
city: Hollywood
country: United States
facility: Millennium Oncology
state: Florida
city: Ocala
country: United States
facility: Ocala Oncology, P.A.
state: Florida
city: Tallahassee
country: United States
facility: Tallahassee Memorial Cancer Center
state: Florida
city: Weston
country: United States
facility: Cleveland Clinic of Florida
state: Florida
city: Savannah
country: United States
facility: Candler Medical Oncology Practice
state: Georgia
city: Tifton
country: United States
facility: Tift Regional Health System Anita Stewart Oncology Center
state: Georgia
city: Honolulu
country: United States
facility: Kaiser Permanente Center for Health Research
state: Hawaii
city: Boise
country: United States
facility: Saint Alphonsus Regional Medical Center
state: Idaho
city: Wichita
country: United States
facility: Cancer Center of Kansas
state: Kansas
city: New Orleans
country: United States
facility: Touro Infirmary
state: Louisiana
city: Shreveport
country: United States
facility: Willis-Knighton Cancer Center
state: Louisiana
city: York
country: United States
facility: York Hospital
state: Maine
city: Worcester
country: United States
facility: Reliant Medical Group, Inc.
state: Massachusetts
city: Detroit
country: United States
facility: Karmanos Cancer Institute
state: Michigan
city: Oxford
country: United States
facility: Baptist Cancer Center
state: Mississippi
city: Grand Island
country: United States
facility: St. Francis Medical Center
state: Nebraska
city: Omaha
country: United States
facility: Oncology Hematology West
state: Nebraska
city: Las Vegas
country: United States
facility: OptumCare Cancer Care
state: Nevada
city: Summit
country: United States
facility: Carol Simon Cancer Center at Overlook Medical Center
state: New Jersey
city: Brooklyn
country: United States
facility: Brooklyn Methodist Hospital
state: New York
city: New York
country: United States
facility: Weill Cornell Medical College
state: New York
city: Stony Brook
country: United States
facility: SUNY At Stony Brook
state: New York
city: White Plains
country: United States
facility: White Plains Hospital
state: New York
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
city: York
country: United States
facility: Cancer Care Associates of York
state: Pennsylvania
city: Providence
country: United States
facility: Womens and Infants
state: Rhode Island
city: Memphis
country: United States
facility: Baptist Cancer Center
state: Tennessee
city: Fort Worth
country: United States
facility: The Center for Cancer and Blood Disorders
state: Texas
city: Houston
country: United States
facility: Oncology Consultants, P.A.
state: Texas
city: The Woodlands
country: United States
facility: Renovatio Clinical
state: Texas
city: Burlington
country: United States
facility: University of Vermont Medical Center
state: Vermont
city: Everett
country: United States
facility: Providence Regional Cancer Partnership
state: Washington
city: Spokane
country: United States
facility: Cancer Care Northwest
state: Washington
city: Coto Laurel
country: Puerto Rico
facility: Centro Integrado de Cancer del Sur, PSC
city: Mayaguez
country: Puerto Rico
facility: Bella Vista Oncology Group
city: Ponce
country: Puerto Rico
facility: Ponce Medical School
city: Ponce
country: Puerto Rico
facility: Centro de Cancer de la Mujer
city: San Juan
country: Puerto Rico
facility: Clinical Research Puerto Rico, Inc.
city: San Juan
country: Puerto Rico
facility: Fundacion de Investigacion de Diego
Study officials:
affiliation: Eli Lilly and Company
name: 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)
role: STUDY_DIRECTOR
References: