A Study of Abemaciclib (LY2835219) in Participants With HR+, HER2- Advanced Breast Cancer

NCT03988114 | Withdrawn Phase 4 FDA Drug

• 3 other identifiers: 17395I3Y-MC-JPCX2019-001781-16
• Study Type: interventional
• Target: N/A
• Locations: 9 countries
• Sites: 119

Brief Summary

The reason for this study is to see if the drug abemaciclib in combination with nonsteroidal aromatase inhibitors (anastrozole or letrozole) is effective in participants with Hormone Receptor Positive (HR+), Human Epidermal Growth Factor Receptor 2 Negative (HER2-) advanced breast cancer that have certain disease characteristics.

Conditions

Metastatic Breast Cancer

Outcome Measures

Primary Outcomes (2)

• Progression Free Survival (PFS)

  PFS

  Baseline to Progressive Disease or Death from Any Cause (Estimated up to 26 Months)

• Objective Response Rate (ORR): Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR)

  ORR

  Baseline to Objective Disease Progression (Estimated up to 26 Months)

Secondary Outcomes (4)

• Duration of Response (DoR)

  Date of CR or PR to Date of Objective Disease Progression or Death from Any Cause (Estimated up to 26 Months)

• Disease Control Rate (DCR): Percentage of Participants with a Best Overall Response of CR, PR, or Stable Disease (SD)

  Baseline to Objective Disease Progression (Estimated up to 26 Months)

• Clinical Benefit Rate (CBR): Proportion of Participants with Best Overall Response of CR, PR, or SD with Duration of SD for at Least 6 Months

  Date of CR, PR or SD to 6 Months Post CR, PR or SD (Estimated up to 26 Months)

• Time to Response (TTR)

  Baseline to Date of CR or PR (Estimated up to 26 Months)

Study Arms (1)

Abemaciclib + NSAI

EXPERIMENTAL

Abemaciclib given orally and nonsteroidal aromatase inhibitor (NSAI) of physician's choice (anastrazole or letrozole) given orally.

Drug: Abemaciclib; Drug: Nonsteroidal Aromatase Inhibitor (NSAI)

Interventions

Abemaciclib DRUG

Administered orally

Also known as: LY2835219

Abemaciclib + NSAI

Nonsteroidal Aromatase Inhibitor (NSAI) DRUG

Letrozole administered orally or anastrozole administered orally (physician choice)

Abemaciclib + NSAI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must have completed (neo) adjuvant endocrine therapy and have cancer return after at least 12 months or have de novo cancer that has spread to other organs at diagnosis
• Participants must have 1 or more of the following:
• A high grade tumor in tissue
• Negative progesterone receptor (PR) status
• Have cancer that has spread to the liver
• Have a treatment-free interval (TFI) \<36 months
• Participants must have HR+, HER2- breast cancer
• Participants must have adequate organ function

You may not qualify if:

• Participants must not have cancer that has spread to other organs that has severely affected their function
• Participants must not have cancer that has spread to the brain that is unstable or untreated
• Participants must not have received endocrine therapy in the metastatic setting
• Participants must not have known active infection
• Participants must not have received prior endocrine therapy and had disease return within 12 months from completion of treatment
• Participants must not have received prior treatment with any cyclin-dependent kinase (CDK) 4 \& 6 inhibitor or everolimus

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (119)

Southern Cancer Center, P.C.

Daphne, Alabama, 36526, United States

Location

Arizona Oncology Associates, P.C.

Tempe, Arizona, 85284, United States

Location

Compassionate Cancer Care Medical Group Inc

Fountain Valley, California, 92708, United States

Location

California Cancer Associates Research and Excellence (cCARE)

Fresno, California, 93720, United States

Location

Beaver Medical Group

Highland, California, 92346, United States

Location

Pacific Cancer Care

Monterey, California, 93940, United States

Location

St. Joseph Hospital

Orange, California, 92868, United States

Location

Comprehensive Cancer Centers of the Desert

Palm Springs, California, 92262, United States

Location

California Cancer Associates in Research and Excellence

San Marcos, California, 92069, United States

Location

Cancer Center of Santa Barbara with Sansum Clinic

Santa Barbara, California, 93105, United States

Location

UCLA Medical Center

Torrance, California, 90502, United States

Location

Memorial Hospital

Colorado Springs, Colorado, 80909, United States

Location

Rocky Mountain Cancer Center

Lone Tree, Colorado, 80124, United States

Location

Medical Oncology Hematology Consultants, PA

Newark, Delaware, 19713, United States

Location

BayCare Medical Group

Clearwater, Florida, 33756, United States

Location

Florida Cancer Specialists

Fort Myers, Florida, 33901, United States

Location

Woodlands Medical Specialists

Pensacola, Florida, 32503, United States

Location

Cancer Specialists of North Florida -St Augustine

Saint Augustine, Florida, 32086, United States

Location

Florida Cancer Specialists

St. Petersburg, Florida, 33705, United States

Location

Florida Cancer Specialists

Tallahassee, Florida, 32308, United States

Location

Florida Cancer Specialists

West Palm Beach, Florida, 33401, United States

Location

Cleveland Clinic of Florida

Weston, Florida, 33331, United States

Location

Summit Cancer Care

Savannah, Georgia, 31404, United States

Location

Ingalls Memorial Hospital

Harvey, Illinois, 60426, United States

Location

Illinois Cancer Specialists-Niles

Niles, Illinois, 60714, United States

Location

Community Health Network

Indianapolis, Indiana, 46219, United States

Location

Central Maine Medical Center

Lewiston, Maine, 04240, United States

Location

York Hospital

York Village, Maine, 03909, United States

Location

HCA Midwest

Kansas City, Missouri, 64132, United States

Location

Oncology Hematology West

Omaha, Nebraska, 68130, United States

Location

Comprehensive Cancer Centers of Nevada

Henderson, Nevada, 89052, United States

Location

Valley Health System

Paramus, New Jersey, 07652, United States

Location

Broome Oncology LLC

Johnson City, New York, 13790, United States

Location

Abington Hematology Oncology Associates

Horsham, Pennsylvania, 19044, United States

Location

Charleston Hematology Oncology Associates

Charleston, South Carolina, 29414, United States

Location

Sarah Cannon Research Institute SCRI

Nashville, Tennessee, 37203, United States

Location

Tennessee Oncology PLLC

Nashville, Tennessee, 37203, United States

Location

Texas Oncology - Abilene

Abilene, Texas, 79606, United States

Location

Texas Oncology - Amarillo

Amarillo, Texas, 79106, United States

Location

Texas Oncology-Arlington South

Arlington, Texas, 76014, United States

Location

Texas Oncology Cancer Center

Austin, Texas, 78731, United States

Location

Texas Oncology - Bedford

Bedford, Texas, 76022, United States

Location

Texas Oncology P.A.

Dallas, Texas, 75203, United States

Location

Texas Oncology - Medical City Dallas

Dallas, Texas, 75230, United States

Location

Texas Oncology - Dallas Presbyterian Hospital

Dallas, Texas, 75231, United States

Location

Texas Oncology-Baylor Charles A. Sammons Cancer Center

Dallas, Texas, 75246, United States

Location

Texas Oncology - Marnie McFadden Ward Cancer Center

Dallas, Texas, 77702, United States

Location

Texas Oncology P.A.

El Paso, Texas, 79902, United States

Location

Texas Oncology Flower Mound

Flower Mound, Texas, 75028, United States

Location

The Center for Cancer and Blood Disorders

Fort Worth, Texas, 76104, United States

Location

Texas Oncology-Memorial City

Houston, Texas, 77024, United States

Location

Renovatio Clinical

Houston, Texas, 77056, United States

Location

Texas Oncology - McAllen

McAllen, Texas, 78503, United States

Location

Texas Oncology-McKinney

McKinney, Texas, 75771, United States

Location

Texas Oncology- Mesquite

Mesquite, Texas, 75150, United States

Location

Texas Oncology - Midland Allison Cancer Center

Midland, Texas, 79701, United States

Location

Texas Oncology - Paris

Paris, Texas, 75460, United States

Location

Texas Oncology-Plano East

Plano, Texas, 75075, United States

Location

Texas Oncology-Plano West

Plano, Texas, 75093, United States

Location

Texas Oncology - San Antonio Medical Center

San Antonio, Texas, 78217, United States

Location

Texas Oncology-Sherman

Sherman, Texas, 75090-0504, United States

Location

US Oncology

The Woodlands, Texas, 77380, United States

Location

Tyler Cancer Center

Tyler, Texas, 75702, United States

Location

Texas Oncology-Deke Slayton Cancer Center

Webster, Texas, 77598-4219, United States

Location

Texas Oncology-Wichital Falls Texoma Cancer Center

Wichita Falls, Texas, 76310, United States

Location

Intermountain Medical Center

St. George, Utah, 84790, United States

Location

Hematology Oncology Associates of Fredericksburg Inc.

Fredericksburg, Virginia, 22408, United States

Location

Virginia Oncology Associates

Norfolk, Virginia, 23502, United States

Location

Oncology and Hematology Associates of Southwest Virginia Inc

Salem, Virginia, 24153, United States

Location

Shenandoah Oncology, P.C.

Winchester, Virginia, 22601, United States

Location

Centro de Oncologia e Investigacion Buenos Aires

Berazategui, Buenos Aires, B1884BBF, Argentina

Location

CEMEDIC

CABA, Buenos Aires, C1440CFD, Argentina

Location

CENIT Centro de Neurociencias, Investigación y Tratamiento

CABA, Ciudad Autonoma Buenos Aires, C1125ABD, Argentina

Location

Centro Medico San Roque

San Miguel de Tucumán, Tucumán Province, T4000IAK, Argentina

Location

Clinica Adventista de Belgrano

Ciudad Autonoma Buenos Aires, C1430EGF, Argentina

Location

Sanatorio Parque

Salta, 4400, Argentina

Location

Centro Polivalente de Asistencia e Inv. Clinica CER-San Juan

San Juan, J5402DIL, Argentina

Location

Centro para la Atencion Integral del Paciente Oncologico

Tucumain, 4000, Argentina

Location

Universitätsklinikum Graz

Graz, Styria, 8036, Austria

Location

Universitätsklinik Innsbruck

Innsbruck, Tyrol, 6020, Austria

Location

Universitätsklinikum Salzburg

Salzburg, 5020, Austria

Location

AKH

Vienna, 1090, Austria

Location

Algemeen Ziekenhuis St Jan Brugge

Bruges, 8000, Belgium

Location

Hopital De Jolimont

Haine-St.- Paul, 7100, Belgium

Location

VZW REgional Ziekenhuis Jan Yperman

Ieper, 8900, Belgium

Location

Clinique Saint Pierre Ottignies

Ottignies, 1340, Belgium

Location

Núcleo de Oncologia da Bahia

Salvador, Estado de Bahia, 41170, Brazil

Location

Instituto de Cancer de Londrina

Londrina, Paraná, 86015-520, Brazil

Location

Instituto COI de Pesquisa Educação e Gestão

Rio de Janeiro, Rio de Janeiro, 22793-080, Brazil

Location

Hospital de Caridade Ijui

Ijuí, Rio Grande do Sul, 98700 000, Brazil

Location

Hospital Bruno Born de Lajeado

Lajeado, Rio Grande do Sul, 95900-000, Brazil

Location

Hospital São Lucas - PUCRS - ONCOLOGY

Porto Alegre, Rio Grande do Sul, 90610-000, Brazil

Location

Fundação PIO XII

Barretos, São Paulo, 14784700, Brazil

Location

Hospital das Clinicas da FMRP

Ribeirão Preto, São Paulo, 14048-900, Brazil

Location

Faculdade de Medicina do ABC

Santo André, São Paulo, 09060-020, Brazil

Location

Hospital de Base Fac de Medicina de Sao Jose do Rio Preto

Sao Jose Rio Preto, São Paulo, 15090-000, Brazil

Location

INCA - Instituto Nacional Do Cancer

Rio de Janeiro, 20231, Brazil

Location

Soc. Beneficente de Senhoras Hospital Sirio Libanes-Oncology

São Paulo, 01246, Brazil

Location

Clin. Pesq.e Centro Estudos Oncologia Ginecológica e Mamária

São Paulo, 01317-000, Brazil

Location

Fundacao Antonio Prudente-Hosp. do Cancer AC Camargo

São Paulo, 01509-900, Brazil

Location

Clinica Onco Star

São Paulo, 04501-000, Brazil

Location

Hämatologisch-Onkologische Praxis Augsburg

Augsburg, Bavaria, 86150, Germany

Location

Universität Leipzig - Universitätsklinikum

Leipzig, Saxony, 04103, Germany

Location

St. Vincenz-Krankenhaus GmbH-Frauen- und Kinderklinik St. Louise

Paderborn, 33098, Germany

Location

Istituto Tumori Fondazione G. Pascale IRCCS

Napoli, Naples, 80131, Italy

Location

Fondazione Piemonte l'Oncologia-Istituto Ricerca Cura Cancro

Candiolo, Torino, 10060, Italy

Location

Policlinico S. Orsola Malpighi - Universita di Bologna

Bologna, 40138, Italy

Location

Azienda Ospedaliera Universitaria Ospedale San Martino di Genova

Genova, 16132, Italy

Location

IRCCS Ospedale San Raffaele

Milan, 20132, Italy

Location

Istituto Oncologico Veneto

Padua, 35128, Italy

Location

Centro di Riferimento Oncologico

Udine, 33100, Italy

Location

Puerto Rico Hematology/Oncology Group

Bayamón, PR, 00959, Puerto Rico

Location

Ad-Vance Medical Research

Ponce, 00717, Puerto Rico

Location

E-DA Cancer Hospital

Kaohsiung City, 82445, Taiwan

Location

China Medical University Hospital

Taichung, 40447, Taiwan

Location

Taichung Veterans General Hospital

Taichung, 40705, ROC, Taiwan

Location

National Cheng Kung University Hospital

Tainan, 704, Taiwan

Location

MacKay Memorial Hospital

Taipei, 10449, Taiwan

Location

Koo Foundation Sun Yan-Sen Cancer Center

Taipei, 11259, Taiwan

Location

Related Links

• A Study of Abemaciclib (LY2835219) in Participants With HR+, HER2- Advanced Breast Cancer

MeSH Terms

Conditions

Breast Neoplasms

Interventions

abemaciclib

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• 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)

  Eli Lilly and Company

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR
• Expanded Access: Yes

Study Record Dates

• First Submitted: June 12, 2019
• First Posted: June 17, 2019
• Study Start: September 16, 2019
• Primary Completion: March 23, 2022
• Study Completion: March 23, 2023
• Last Updated: September 6, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• 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.
• Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

Locations

DE (3); BR (15); AR (8); US (70); IT (7); BE (4); PR (2); TW (6); AU (4)