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A Study of Abemaciclib (LY2835219) in Combination With Fulvestrant Compared to Chemotherapy in Women With HR Positive, HER2 Negative Metastatic Breast Cancer

Primary Purpose

Metastatic Breast Cancer

Status
Terminated
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Abemaciclib
Fulvestrant
Standard Chemotherapy
Sponsored by
Eli Lilly and Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Breast Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Scottsdale Healthcare Hospitals
  • University of Arizona Cancer Center
  • Yuma Regional Cancer Center
  • CARTI Cancer Center
  • Comprehensive Blood and Cancer Center
  • Compassionate Cancer Care Medical Group Inc
  • Chan Soon- Shiong Institute for Medicine
  • Chan Soon- Shiong Institute for Medicine
  • Compassionate Cancer Care Medical Group Inc
  • St. Joseph Heritage Healthcare
  • Scripps Clinic
  • UCLA Medical Center
  • TRIO - Translational Research in Oncology-US, Inc.
  • Univ of California Irvine College of Medicine
  • Comprehensive Cancer Centers of the Desert
  • Desert Hematology Oncology Medical Group
  • Emad Ibrahim, MD, INC
  • Compassionate Cancer Care Medical Group Inc
  • University of California, Davis - Health Systems
  • Torrance Memorial Medical Center
  • Banner MD Anderson Cancer Center
  • Hartford Hospital
  • Millennium Oncology
  • Ocala Oncology, P.A.
  • Tallahassee Memorial Cancer Center
  • Cleveland Clinic of Florida
  • Candler Medical Oncology Practice
  • Tift Regional Health System Anita Stewart Oncology Center
  • Kaiser Permanente Center for Health Research
  • Saint Alphonsus Regional Medical Center
  • Cancer Center of Kansas
  • Touro Infirmary
  • Willis-Knighton Cancer Center
  • York Hospital
  • Reliant Medical Group, Inc.
  • Karmanos Cancer Institute
  • Baptist Cancer Center
  • St. Francis Medical Center
  • Oncology Hematology West
  • OptumCare Cancer Care
  • Carol Simon Cancer Center at Overlook Medical Center
  • Brooklyn Methodist Hospital
  • Weill Cornell Medical College
  • SUNY At Stony Brook
  • White Plains Hospital
  • University Hospitals Cleveland Medical Center
  • Cancer Care Associates of York
  • Womens and Infants
  • Baptist Cancer Center
  • The Center for Cancer and Blood Disorders
  • Oncology Consultants, P.A.
  • Renovatio Clinical
  • University of Vermont Medical Center
  • Providence Regional Cancer Partnership
  • Cancer Care Northwest
  • Centro Integrado de Cancer del Sur, PSC
  • Bella Vista Oncology Group
  • Ponce Medical School
  • Centro de Cancer de la Mujer
  • Clinical Research Puerto Rico, Inc.
  • Fundacion de Investigacion de Diego

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Abemaciclib + Fulvestrant

Standard Chemotherapy

Arm Description

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 of physician's choice (capecitabine, docetaxel, nab paclitaxel, or paclitaxel), administered according to product label.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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 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.
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.
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.

Full Information

First Posted
July 23, 2019
Last Updated
July 29, 2021
Sponsor
Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT04031885
Brief Title
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

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Terminated
Why Stopped
Business decision based on the inability to enroll subjects into the trial
Study Start Date
August 14, 2019 (Actual)
Primary Completion Date
August 11, 2020 (Actual)
Study Completion Date
August 11, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eli Lilly and Company

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Breast Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Abemaciclib + Fulvestrant
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard Chemotherapy
Arm Type
Active Comparator
Arm Description
Standard chemotherapy of physician's choice (capecitabine, docetaxel, nab paclitaxel, or paclitaxel), administered according to product label.
Intervention Type
Drug
Intervention Name(s)
Abemaciclib
Other Intervention Name(s)
LY2835219
Intervention Description
Administered orally
Intervention Type
Drug
Intervention Name(s)
Fulvestrant
Intervention Description
Administered IM
Intervention Type
Drug
Intervention Name(s)
Standard Chemotherapy
Other Intervention Name(s)
Capecitabine, Docetaxel, Nab paclitaxel, Paclitaxel
Intervention Description
Standard chemotherapy of physician's choice administered according to product label.
Primary Outcome Measure Information:
Title
Objective Response Rate (ORR): Percentage of Participants Who Achieve Complete Response (CR) or Partial Response (PR)
Description
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)
Secondary Outcome Measure Information:
Title
Progression Free Survival (PFS)
Description
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)
Title
Time to Response (TTR)
Description
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)
Title
Duration of Response (DoR)
Description
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)
Title
Progression Free Survival 2 (PFS 2)
Description
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)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
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)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
Scottsdale Healthcare Hospitals
City
Avondale
State/Province
Arizona
ZIP/Postal Code
85392
Country
United States
Facility Name
University of Arizona Cancer Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85004
Country
United States
Facility Name
Yuma Regional Cancer Center
City
Yuma
State/Province
Arizona
ZIP/Postal Code
85364
Country
United States
Facility Name
CARTI Cancer Center
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Comprehensive Blood and Cancer Center
City
Bakersfield
State/Province
California
ZIP/Postal Code
93309
Country
United States
Facility Name
Compassionate Cancer Care Medical Group Inc
City
Corona
State/Province
California
ZIP/Postal Code
92879
Country
United States
Facility Name
Chan Soon- Shiong Institute for Medicine
City
Costa Mesa
State/Province
California
ZIP/Postal Code
92627
Country
United States
Facility Name
Chan Soon- Shiong Institute for Medicine
City
El Segundo
State/Province
California
ZIP/Postal Code
90245
Country
United States
Facility Name
Compassionate Cancer Care Medical Group Inc
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
Country
United States
Facility Name
St. Joseph Heritage Healthcare
City
Fullerton
State/Province
California
ZIP/Postal Code
92835
Country
United States
Facility Name
Scripps Clinic
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
UCLA Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90024
Country
United States
Facility Name
TRIO - Translational Research in Oncology-US, Inc.
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Univ of California Irvine College of Medicine
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Comprehensive Cancer Centers of the Desert
City
Palm Springs
State/Province
California
ZIP/Postal Code
92262
Country
United States
Facility Name
Desert Hematology Oncology Medical Group
City
Rancho Mirage
State/Province
California
ZIP/Postal Code
92270
Country
United States
Facility Name
Emad Ibrahim, MD, INC
City
Redlands
State/Province
California
ZIP/Postal Code
92373
Country
United States
Facility Name
Compassionate Cancer Care Medical Group Inc
City
Riverside
State/Province
California
ZIP/Postal Code
92501
Country
United States
Facility Name
University of California, Davis - Health Systems
City
Sacramento
State/Province
California
ZIP/Postal Code
95864
Country
United States
Facility Name
Torrance Memorial Medical Center
City
Torrance
State/Province
California
ZIP/Postal Code
90505
Country
United States
Facility Name
Banner MD Anderson Cancer Center
City
Greeley
State/Province
Colorado
ZIP/Postal Code
80631
Country
United States
Facility Name
Hartford Hospital
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06102-5037
Country
United States
Facility Name
Millennium Oncology
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33024
Country
United States
Facility Name
Ocala Oncology, P.A.
City
Ocala
State/Province
Florida
ZIP/Postal Code
34474
Country
United States
Facility Name
Tallahassee Memorial Cancer Center
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32308
Country
United States
Facility Name
Cleveland Clinic of Florida
City
Weston
State/Province
Florida
ZIP/Postal Code
33331
Country
United States
Facility Name
Candler Medical Oncology Practice
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31405
Country
United States
Facility Name
Tift Regional Health System Anita Stewart Oncology Center
City
Tifton
State/Province
Georgia
ZIP/Postal Code
31794
Country
United States
Facility Name
Kaiser Permanente Center for Health Research
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96819
Country
United States
Facility Name
Saint Alphonsus Regional Medical Center
City
Boise
State/Province
Idaho
ZIP/Postal Code
83706
Country
United States
Facility Name
Cancer Center of Kansas
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
Facility Name
Touro Infirmary
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70115
Country
United States
Facility Name
Willis-Knighton Cancer Center
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71103
Country
United States
Facility Name
York Hospital
City
York
State/Province
Maine
ZIP/Postal Code
03909
Country
United States
Facility Name
Reliant Medical Group, Inc.
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01608
Country
United States
Facility Name
Karmanos Cancer Institute
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Baptist Cancer Center
City
Oxford
State/Province
Mississippi
ZIP/Postal Code
38655
Country
United States
Facility Name
St. Francis Medical Center
City
Grand Island
State/Province
Nebraska
ZIP/Postal Code
68803
Country
United States
Facility Name
Oncology Hematology West
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68130
Country
United States
Facility Name
OptumCare Cancer Care
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89102
Country
United States
Facility Name
Carol Simon Cancer Center at Overlook Medical Center
City
Summit
State/Province
New Jersey
ZIP/Postal Code
07901
Country
United States
Facility Name
Brooklyn Methodist Hospital
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11215
Country
United States
Facility Name
Weill Cornell Medical College
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
SUNY At Stony Brook
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794
Country
United States
Facility Name
White Plains Hospital
City
White Plains
State/Province
New York
ZIP/Postal Code
10601
Country
United States
Facility Name
University Hospitals Cleveland Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Cancer Care Associates of York
City
York
State/Province
Pennsylvania
ZIP/Postal Code
17403
Country
United States
Facility Name
Womens and Infants
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02905
Country
United States
Facility Name
Baptist Cancer Center
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38120
Country
United States
Facility Name
The Center for Cancer and Blood Disorders
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
Oncology Consultants, P.A.
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Renovatio Clinical
City
The Woodlands
State/Province
Texas
ZIP/Postal Code
77380
Country
United States
Facility Name
University of Vermont Medical Center
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05401
Country
United States
Facility Name
Providence Regional Cancer Partnership
City
Everett
State/Province
Washington
ZIP/Postal Code
98201
Country
United States
Facility Name
Cancer Care Northwest
City
Spokane
State/Province
Washington
ZIP/Postal Code
99202
Country
United States
Facility Name
Centro Integrado de Cancer del Sur, PSC
City
Coto Laurel
ZIP/Postal Code
00780
Country
Puerto Rico
Facility Name
Bella Vista Oncology Group
City
Mayaguez
ZIP/Postal Code
00680
Country
Puerto Rico
Facility Name
Ponce Medical School
City
Ponce
ZIP/Postal Code
00716
Country
Puerto Rico
Facility Name
Centro de Cancer de la Mujer
City
Ponce
ZIP/Postal Code
00717
Country
Puerto Rico
Facility Name
Clinical Research Puerto Rico, Inc.
City
San Juan
ZIP/Postal Code
00909
Country
Puerto Rico
Facility Name
Fundacion de Investigacion de Diego
City
San Juan
ZIP/Postal Code
00927
Country
Puerto Rico

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing 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.
IPD Sharing Access Criteria
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
IPD Sharing URL
https://vivli.org/
Links:
URL
https://www.lillytrialguide.com/en-US/studies/metastatic-breast-cancer/JPCU#?postal=
Description
A Study of Abemaciclib (LY2835219) in Combination With Fulvestrant Compared to Chemotherapy in Women With HR Positive, HER2 Negative Metastatic Breast Cancer

Learn more about this trial

A Study of Abemaciclib (LY2835219) in Combination With Fulvestrant Compared to Chemotherapy in Women With HR Positive, HER2 Negative Metastatic Breast Cancer

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