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

July 29, 2021 updated by: Eli Lilly and Company

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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
4

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Expanded Access

Expanded Access

A way for patients with serious diseases or conditions who cannot participate in a clinical trial to gain access to a medical product that has not been approved by the U.S. Food and Drug Administration (FDA). Also called compassionate use. There are different expanded access types.
Available

Available

  • Available: Expanded access is currently available for this investigational treatment, and patients who are not participants in the clinical study may be able to gain access to the drug, biologic, or medical device being studied.
  • No longer available: Expanded access was available for this intervention previously but is not currently available and will not be available in the future.
  • Temporarily not available: Expanded access is not currently available for this intervention but is expected to be available in the future.
  • Approved for marketing: The intervention has been approved by the U.S. Food and Drug Administration for use by the public.
 outside the clinical trial. See expanded access record.

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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
        • Fundacion De Investigacion 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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Objective Response Rate (ORR): Percentage of Participants Who Achieve Complete Response (CR) or Partial Response (PR)
Time Frame: Randomization to Measured Progressive Disease (Up to 12 Months)
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Progression Free Survival (PFS)
Time Frame: First Dose Date to Objective Progression or Death Due to Any Cause (Up to 12 Months)
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)
Time Frame: First Dose to Date of CR or PR (Up to 12 Months)
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)
Time Frame: Date of CR or PR to Date of Objective Progression or Death Due to Any Cause (Up to 12 Months)
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)
Time Frame: Randomization to Second Objective Progression or Death Due to Any Cause (Up to 12 Months)
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Eli Lilly and Company

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 14, 2019

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 11, 2020

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 11, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 23, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 23, 2019

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 24, 2019

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 24, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 29, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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