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Metastatic Breast CancerPhase 4NCT04031885

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

A Phase 4 study testing Abemaciclib, Fulvestrant and Standard Chemotherapy in people with Metastatic Breast Cancer, run by Eli Lilly and Company at 61 sites in 2 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Metastatic Breast Cancer
What is being tested?
Abemaciclib, Fulvestrant and Standard Chemotherapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
4 participants
Where
61 sitesin 2 countries
Study dates
14 Aug 2019to 11 Aug 2020
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

61 sites in 2 countries.

61 sites in 2 countries

United States55 sites

  • Scottsdale Healthcare Hospitals

    Avondale, Arizona, 85392

  • Comprehensive Blood and Cancer Center

    Bakersfield, California, 93309

  • Saint Alphonsus Regional Medical Center

    Boise, Idaho, 83706

  • Brooklyn Methodist Hospital

    Brooklyn, New York, 11215

  • University of Vermont Medical Center

    Burlington, Vermont, 05401

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106

  • Compassionate Cancer Care Medical Group Inc

    Corona, California, 92879

  • Chan Soon- Shiong Institute for Medicine

    Costa Mesa, California, 92627

  • Karmanos Cancer Institute

    Detroit, Michigan, 48201

  • Chan Soon- Shiong Institute for Medicine

    El Segundo, California, 90245

  • Providence Regional Cancer Partnership

    Everett, Washington, 98201

  • The Center for Cancer and Blood Disorders

    Fort Worth, Texas, 76104

  • Compassionate Cancer Care Medical Group Inc

    Fountain Valley, California, 92708

  • St. Joseph Heritage Healthcare

    Fullerton, California, 92835

  • St. Francis Medical Center

    Grand Island, Nebraska, 68803

  • Banner MD Anderson Cancer Center

    Greeley, Colorado, 80631

  • Hartford Hospital

    Hartford, Connecticut, 06102-5037

  • Millennium Oncology

    Hollywood, Florida, 33024

  • Kaiser Permanente Center for Health Research

    Honolulu, Hawaii, 96819

  • Oncology Consultants, P.A.

    Houston, Texas, 77030

  • Scripps Clinic

    La Jolla, California, 92037

  • OptumCare Cancer Care

    Las Vegas, Nevada, 89102

  • CARTI Cancer Center

    Little Rock, Arkansas, 72205

  • UCLA Medical Center

    Los Angeles, California, 90024

  • TRIO - Translational Research in Oncology-US, Inc.

    Los Angeles, California, 90095

  • Baptist Cancer Center

    Memphis, Tennessee, 38120

  • Touro Infirmary

    New Orleans, Louisiana, 70115

  • Weill Cornell Medical College

    New York, New York, 10065

  • Ocala Oncology, P.A.

    Ocala, Florida, 34474

  • Oncology Hematology West

    Omaha, Nebraska, 68130

  • Univ of California Irvine College of Medicine

    Orange, California, 92868

  • Baptist Cancer Center

    Oxford, Mississippi, 38655

  • Comprehensive Cancer Centers of the Desert

    Palm Springs, California, 92262

  • University of Arizona Cancer Center

    Phoenix, Arizona, 85004

  • Womens and Infants

    Providence, Rhode Island, 02905

  • Desert Hematology Oncology Medical Group

    Rancho Mirage, California, 92270

  • Emad Ibrahim, MD, INC

    Redlands, California, 92373

  • Compassionate Cancer Care Medical Group Inc

    Riverside, California, 92501

  • University of California, Davis - Health Systems

    Sacramento, California, 95864

  • Candler Medical Oncology Practice

    Savannah, Georgia, 31405

  • Willis-Knighton Cancer Center

    Shreveport, Louisiana, 71103

  • Cancer Care Northwest

    Spokane, Washington, 99202

  • SUNY At Stony Brook

    Stony Brook, New York, 11794

  • Carol Simon Cancer Center at Overlook Medical Center

    Summit, New Jersey, 07901

  • Tallahassee Memorial Cancer Center

    Tallahassee, Florida, 32308

  • Renovatio Clinical

    The Woodlands, Texas, 77380

  • Tift Regional Health System Anita Stewart Oncology Center

    Tifton, Georgia, 31794

  • Torrance Memorial Medical Center

    Torrance, California, 90505

  • Cleveland Clinic of Florida

    Weston, Florida, 33331

  • White Plains Hospital

    White Plains, New York, 10601

  • Cancer Center of Kansas

    Wichita, Kansas, 67214

  • Reliant Medical Group, Inc.

    Worcester, Massachusetts, 01608

  • Cancer Care Associates of York

    York, Pennsylvania, 17403

  • York Hospital

    York Village, Maine, 03909

  • Yuma Regional Cancer Center

    Yuma, Arizona, 85364

Other trials in United States

Puerto Rico6 sites

  • Centro Integrado de Cancer del Sur, PSC

    Coto Laurel, PR, 00780

  • Bella Vista Oncology Group

    Mayagüez, PR, 00680

  • Ponce Medical School

    Ponce, PR, 00716

  • Centro de Cancer de la Mujer

    Ponce, PR, 00717

  • Fundacion de Investigacion de Diego

    San Juan, PR, 00927

  • Clinical Research Puerto Rico, Inc.

    San Juan, 00909

Other trials in Puerto Rico

About this study

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

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.

Being tested
Abemaciclib, Fulvestrant, Standard Chemotherapy
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AbemaciclibDrug

    Also called LY2835219

    Administered orally

  • FulvestrantDrug

    Administered IM

  • Standard ChemotherapyDrug

    Also called Capecitabine, Docetaxel, Nab paclitaxel, Paclitaxel

    Standard chemotherapy of physician's choice administered according to product label.

Study groups in NCT04031885
Study groupRoleWhat they receive
Abemaciclib + FulvestrantExperimental150 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.
Receives: Drug: Abemaciclib; Drug: Fulvestrant
Standard ChemotherapyActive comparatorStandard chemotherapy of physician's choice (capecitabine, docetaxel, nab paclitaxel, or paclitaxel), administered according to product label.
Receives: Drug: Standard Chemotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Randomization to Measured Progressive Disease (Up to 12 Months)

Secondary outcomes (4)

  1. 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.

    Measured: First Dose Date to Objective Progression or Death Due to Any Cause (Up to 12 Months)

  2. 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.

    Measured: First Dose to Date of CR or PR (Up to 12 Months)

  3. 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.

    Measured: Date of CR or PR to Date of Objective Progression or Death Due to Any Cause (Up to 12 Months)

  4. 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.

    Measured: Randomization to Second Objective Progression or Death Due to Any Cause (Up to 12 Months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jul 2019
  2. Study start14 Aug 2019
  3. Primary completion11 Aug 2020
  4. Study completion11 Aug 2020

Why it stopped: Business decision based on the inability to enroll subjects into the trial

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
4 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04031885
Sponsor's protocol ID
17320
Other IDs
I3Y-MC-JPCU
Status last verified
Jul 2021
First submitted
23 Jul 2019
Last updated
24 Aug 2021
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.
Expanded access
Available

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Abemaciclib, Fulvestrant and Standard Chemotherapy in people with Metastatic Breast Cancer, run by Eli Lilly and Company at 61 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 24 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 61 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Aug 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04031885.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2021.

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