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

Metastatic Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04031885
• Other study ID #: 17320
• Secondary ID: I3Y-MC-JPCU
• Status: Terminated
• Phase: Phase 4
• Start date: August 14, 2019
• Est. completion date: August 11, 2020

Study information

• Verified date: July 2021
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: August 11, 2020
• Est. primary completion date: August 11, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms
• Metastatic Breast Cancer

Intervention

Drug:
• Abemaciclib
Administered orally
• Fulvestrant
Administered IM
• Standard Chemotherapy
Standard chemotherapy of physician's choice administered according to product label.

Locations

Country	Name	City	State
Puerto Rico	Centro Integrado de Cancer del Sur, PSC	Coto Laurel
Puerto Rico	Bella Vista Oncology Group	Mayaguez
Puerto Rico	Centro de Cancer de la Mujer	Ponce
Puerto Rico	Ponce Medical School	Ponce
Puerto Rico	Clinical Research Puerto Rico, Inc.	San Juan
Puerto Rico	Fundacion de Investigacion de Diego	San Juan
United States	Scottsdale Healthcare Hospitals	Avondale	Arizona
United States	Comprehensive Blood and Cancer Center	Bakersfield	California
United States	Saint Alphonsus Regional Medical Center	Boise	Idaho
United States	Brooklyn Methodist Hospital	Brooklyn	New York
United States	University of Vermont Medical Center	Burlington	Vermont
United States	University Hospitals Cleveland Medical Center	Cleveland	Ohio
United States	Compassionate Cancer Care Medical Group Inc	Corona	California
United States	Chan Soon- Shiong Institute for Medicine	Costa Mesa	California
United States	Karmanos Cancer Institute	Detroit	Michigan
United States	Chan Soon- Shiong Institute for Medicine	El Segundo	California
United States	Providence Regional Cancer Partnership	Everett	Washington
United States	The Center for Cancer and Blood Disorders	Fort Worth	Texas
United States	Compassionate Cancer Care Medical Group Inc	Fountain Valley	California
United States	St. Joseph Heritage Healthcare	Fullerton	California
United States	St. Francis Medical Center	Grand Island	Nebraska
United States	Banner MD Anderson Cancer Center	Greeley	Colorado
United States	Hartford Hospital	Hartford	Connecticut
United States	Millennium Oncology	Hollywood	Florida
United States	Kaiser Permanente Center for Health Research	Honolulu	Hawaii
United States	Oncology Consultants, P.A.	Houston	Texas
United States	Scripps Clinic	La Jolla	California
United States	OptumCare Cancer Care	Las Vegas	Nevada
United States	CARTI Cancer Center	Little Rock	Arkansas
United States	TRIO - Translational Research in Oncology-US, Inc.	Los Angeles	California
United States	UCLA Medical Center	Los Angeles	California
United States	Baptist Cancer Center	Memphis	Tennessee
United States	Touro Infirmary	New Orleans	Louisiana
United States	Weill Cornell Medical College	New York	New York
United States	Ocala Oncology, P.A.	Ocala	Florida
United States	Oncology Hematology West	Omaha	Nebraska
United States	Univ of California Irvine College of Medicine	Orange	California
United States	Baptist Cancer Center	Oxford	Mississippi
United States	Comprehensive Cancer Centers of the Desert	Palm Springs	California
United States	University of Arizona Cancer Center	Phoenix	Arizona
United States	Womens and Infants	Providence	Rhode Island
United States	Desert Hematology Oncology Medical Group	Rancho Mirage	California
United States	Emad Ibrahim, MD, INC	Redlands	California
United States	Compassionate Cancer Care Medical Group Inc	Riverside	California
United States	University of California, Davis - Health Systems	Sacramento	California
United States	Candler Medical Oncology Practice	Savannah	Georgia
United States	Willis-Knighton Cancer Center	Shreveport	Louisiana
United States	Cancer Care Northwest	Spokane	Washington
United States	SUNY At Stony Brook	Stony Brook	New York
United States	Carol Simon Cancer Center at Overlook Medical Center	Summit	New Jersey
United States	Tallahassee Memorial Cancer Center	Tallahassee	Florida
United States	Renovatio Clinical	The Woodlands	Texas
United States	Tift Regional Health System Anita Stewart Oncology Center	Tifton	Georgia
United States	Torrance Memorial Medical Center	Torrance	California
United States	Cleveland Clinic of Florida	Weston	Florida
United States	White Plains Hospital	White Plains	New York
United States	Cancer Center of Kansas	Wichita	Kansas
United States	Reliant Medical Group, Inc.	Worcester	Massachusetts
United States	Cancer Care Associates of York	York	Pennsylvania
United States	York Hospital	York	Maine
United States	Yuma Regional Cancer Center	Yuma	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	First Dose Date to Objective Progression or Death Due to Any Cause (Up to 12 Months)
Secondary	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.	First Dose to Date of CR or PR (Up to 12 Months)
Secondary	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.	Date of CR or PR to Date of Objective Progression or Death Due to Any Cause (Up to 12 Months)
Secondary	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.	Randomization to Second Objective Progression or Death Due to Any Cause (Up to 12 Months)

External Links

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