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

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.

Study Overview

• Status: Terminated
• Conditions: Metastatic Breast Cancer
• Intervention / Treatment: Drug: Abemaciclib; Drug: Fulvestrant; Drug: Standard Chemotherapy

• Study Type: Interventional
• Enrollment (Actual): 4
• Phase: Phase 4

Expanded Access

Available outside the clinical trial. See expanded access record.

Contacts and Locations

Study Locations

• Puerto Rico
  • Coto Laurel, Puerto Rico, 00780
    • Centro Integrado de Cancer del Sur, PSC
  • Mayaguez, Puerto Rico, 00680
    • Bella Vista Oncology Group
  • Ponce, Puerto Rico, 00716
    • Ponce Medical School
  • Ponce, Puerto Rico, 00717
    • Centro de Cancer de la Mujer
  • San Juan, Puerto Rico, 00927
    • Fundación De Investigación De Diego
  • San Juan, Puerto Rico, 00909
    • Clinical Research Puerto Rico, Inc.
• United States
  • Arizona
    • Avondale, Arizona, United States, 85392
      • Scottsdale Healthcare Hospitals
    • Phoenix, Arizona, United States, 85004
      • University of Arizona Cancer Center
    • Yuma, Arizona, United States, 85364
      • Yuma Regional Cancer Center
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • CARTI Cancer Center
  • California
    • Bakersfield, California, United States, 93309
      • Comprehensive Blood and Cancer Center
    • Corona, California, United States, 92879
      • Compassionate Cancer Care Medical Group Inc
    • Costa Mesa, California, United States, 92627
      • Chan Soon- Shiong Institute for Medicine
    • El Segundo, California, United States, 90245
      • Chan Soon- Shiong Institute for Medicine
    • Fountain Valley, California, United States, 92708
      • Compassionate Cancer Care Medical Group Inc
    • Fullerton, California, United States, 92835
      • St. Joseph Heritage Healthcare
    • La Jolla, California, United States, 92037
      • Scripps Clinic
    • Los Angeles, California, United States, 90024
      • UCLA Medical Center
    • Los Angeles, California, United States, 90095
      • TRIO - Translational Research in Oncology-US, Inc.
    • Orange, California, United States, 92868
      • Univ Of California Irvine College Of Medicine
    • Palm Springs, California, United States, 92262
      • Comprehensive Cancer Centers of the Desert
    • Rancho Mirage, California, United States, 92270
      • Desert Hematology Oncology Medical Group
    • Redlands, California, United States, 92373
      • Emad Ibrahim, MD, INC
    • Riverside, California, United States, 92501
      • Compassionate Cancer Care Medical Group Inc
    • Sacramento, California, United States, 95864
      • University of California, Davis - Health Systems
    • Torrance, California, United States, 90505
      • Torrance Memorial Medical Center
  • Colorado
    • Greeley, Colorado, United States, 80631
      • Banner MD Anderson Cancer Center
  • Connecticut
    • Hartford, Connecticut, United States, 06102-5037
      • Hartford Hospital
  • Florida
    • Hollywood, Florida, United States, 33024
      • Millennium Oncology
    • Ocala, Florida, United States, 34474
      • Ocala Oncology, P.A.
    • Tallahassee, Florida, United States, 32308
      • Tallahassee Memorial Cancer Center
    • Weston, Florida, United States, 33331
      • Cleveland Clinic of Florida
  • Georgia
    • Savannah, Georgia, United States, 31405
      • Candler Medical Oncology Practice
    • Tifton, Georgia, United States, 31794
      • Tift Regional Health System Anita Stewart Oncology Center
  • Hawaii
    • Honolulu, Hawaii, United States, 96819
      • Kaiser Permanente Center for Health Research
  • Idaho
    • Boise, Idaho, United States, 83706
      • Saint Alphonsus Regional Medical Center
  • Kansas
    • Wichita, Kansas, United States, 67214
      • Cancer Center of Kansas
  • Louisiana
    • New Orleans, Louisiana, United States, 70115
      • Touro Infirmary
    • Shreveport, Louisiana, United States, 71103
      • Willis-Knighton Cancer Center
  • Maine
    • York, Maine, United States, 03909
      • York Hospital
  • Massachusetts
    • Worcester, Massachusetts, United States, 01608
      • Reliant Medical Group, Inc.
  • Michigan
    • Detroit, Michigan, United States, 48201
      • Karmanos Cancer Institute
  • Mississippi
    • Oxford, Mississippi, United States, 38655
      • Baptist Cancer Center
  • Nebraska
    • Grand Island, Nebraska, United States, 68803
      • St. Francis Medical Center
    • Omaha, Nebraska, United States, 68130
      • Oncology Hematology West
  • Nevada
    • Las Vegas, Nevada, United States, 89102
      • OptumCare Cancer Care
  • New Jersey
    • Summit, New Jersey, United States, 07901
      • Carol Simon Cancer Center at Overlook Medical Center
  • New York
    • Brooklyn, New York, United States, 11215
      • Brooklyn Methodist Hospital
    • New York, New York, United States, 10065
      • Weill Cornell Medical College
    • Stony Brook, New York, United States, 11794
      • SUNY at Stony Brook
    • White Plains, New York, United States, 10601
      • White Plains Hospital
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • University Hospitals Cleveland Medical Center
  • Pennsylvania
    • York, Pennsylvania, United States, 17403
      • Cancer Care Associates of York
  • Rhode Island
    • Providence, Rhode Island, United States, 02905
      • Womens and Infants
  • Tennessee
    • Memphis, Tennessee, United States, 38120
      • Baptist Cancer Center
  • Texas
    • Fort Worth, Texas, United States, 76104
      • The Center for Cancer and Blood Disorders
    • Houston, Texas, United States, 77030
      • Oncology Consultants, P.A.
    • The Woodlands, Texas, United States, 77380
      • Renovatio Clinical
  • Vermont
    • Burlington, Vermont, United States, 05401
      • University of Vermont Medical Center
  • Washington
    • Everett, Washington, United States, 98201
      • Providence Regional Cancer Partnership
    • Spokane, Washington, United States, 99202
      • Cancer Care Northwest

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Abemaciclib + Fulvestrant; 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.	Drug: Abemaciclib; Administered orally; Other Names: LY2835219; Drug: Fulvestrant; Administered IM
ACTIVE_COMPARATOR: Standard Chemotherapy; Standard chemotherapy of physician's choice (capecitabine, docetaxel, nab paclitaxel, or paclitaxel), administered according to product label.	Drug: Standard Chemotherapy; Standard chemotherapy of physician's choice administered according to product label.; Other Names: Capecitabine; Docetaxel; Paclitaxel; Nab paclitaxel

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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)
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)

Collaborators and Investigators

• Sponsor: Eli Lilly and Company

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 14, 2019
• Primary Completion (ACTUAL): August 11, 2020
• Study Completion (ACTUAL): August 11, 2020

Study Registration Dates

• First Submitted: July 23, 2019
• First Submitted That Met QC Criteria: July 23, 2019
• First Posted (ACTUAL): July 24, 2019

Study Record Updates

• Last Update Posted (ACTUAL): August 24, 2021
• Last Update Submitted That Met QC Criteria: July 29, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Antineoplastic Agents, Phytogenic; Hormone Antagonists; Estrogen Antagonists; Estrogen Receptor Antagonists; Docetaxel; Paclitaxel; Capecitabine; Fulvestrant; Albumin-Bound Paclitaxel
• Other Study ID Numbers: 17320; I3Y-MC-JPCU (OTHER: Eli Lilly and Company)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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 Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No