A Study of Abemaciclib (LY2835219) in Participants With HR+, HER2- Advanced Breast Cancer
- Conditions
- Metastatic Breast Cancer
- Interventions
- Drug: Nonsteroidal Aromatase Inhibitor (NSAI)
- Registration Number
- NCT03988114
- Lead Sponsor
- Eli Lilly and Company
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
-
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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Abemaciclib + NSAI Nonsteroidal Aromatase Inhibitor (NSAI) Abemaciclib given orally and nonsteroidal aromatase inhibitor (NSAI) of physician's choice (anastrazole or letrozole) given orally. Abemaciclib + NSAI Abemaciclib Abemaciclib given orally and nonsteroidal aromatase inhibitor (NSAI) of physician's choice (anastrazole or letrozole) given orally.
- Primary Outcome Measures
Name Time Method Progression Free Survival (PFS) Baseline to Progressive Disease or Death from Any Cause (Estimated up to 26 Months) PFS
Objective Response Rate (ORR): Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR) Baseline to Objective Disease Progression (Estimated up to 26 Months) ORR
- Secondary Outcome Measures
Name Time Method 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) DoR
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) DCR
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) CBR
Time to Response (TTR) Baseline to Date of CR or PR (Estimated up to 26 Months) TTR
Trial Locations
- Locations (115)
BayCare Medical Group
🇺🇸Clearwater, Florida, United States
Texas Oncology-Arlington South
🇺🇸Arlington, Texas, United States
California Cancer Associates Research and Excellence (cCARE)
🇺🇸Fresno, California, United States
Community Health Network
🇺🇸Indianapolis, Indiana, United States
Renovatio Clinical
🇺🇸Houston, Texas, United States
Hospital de Caridade Ijui
🇧🇷Ijui, Rio Grande Do Sul, Brazil
Tennessee Oncology PLLC
🇺🇸Nashville, Tennessee, United States
CENIT Centro de Neurociencias, Investigación y Tratamiento
🇦🇷Caba, Ciudad Autonoma Buenos Aires, Argentina
Hämatologisch-Onkologische Praxis Augsburg
🇩🇪Augsburg, Bavaria, Germany
Algemeen Ziekenhuis St Jan Brugge
🇧🇪Brugge, Belgium
Central Maine Medical Center
🇺🇸Lewiston, Maine, United States
Hospital das Clinicas da FMRP
🇧🇷Ribeirao Preto, São Paulo, Brazil
Clinica Onco Star
🇧🇷São Paulo, Brazil
Centro de Oncologia e Investigacion Buenos Aires
🇦🇷Berazategui, Buenos Aires, Argentina
CEMEDIC
🇦🇷Caba, Buenos Aires, Argentina
Clin. Pesq.e Centro Estudos Oncologia Ginecológica e Mamária
🇧🇷São Paulo, Brazil
Policlinico S. Orsola Malpighi - Universita di Bologna
🇮🇹Bologna, Italy
Azienda Ospedaliera Universitaria Ospedale San Martino di Genova
🇮🇹Genova, Italy
National Cheng Kung University Hospital
🇨🇳Tainan, Taiwan
Comprehensive Cancer Centers of Nevada
🇺🇸Henderson, Nevada, United States
Centro Polivalente de Asistencia e Inv. Clinica CER-San Juan
🇦🇷San Juan, Argentina
Universitätsklinik Innsbruck
🇦🇹Innsbruck, Tirol, Austria
Fundação PIO XII
🇧🇷Barretos, Sao Paulo, Brazil
Fondazione Piemonte l'Oncologia-Istituto Ricerca Cura Cancro
🇮🇹Candiolo, Torino, Italy
Taichung Veterans General Hospital
🇨🇳Taichung, Taiwan
Woodlands Medical Specialists
🇺🇸Pensacola, Florida, United States
IRCCS Ospedale San Raffaele
🇮🇹Milano, Italy
Istituto Oncologico Veneto
🇮🇹Padova, Italy
Centro di Riferimento Oncologico
🇮🇹Udine, Italy
Puerto Rico Hematology/Oncology Group
🇵🇷Bayamon, Puerto Rico
Ad-Vance Medical Research
🇵🇷Ponce, Puerto Rico
China Medical University Hospital
🇨🇳Taichung, Taiwan
MacKay Memorial Hospital
🇨🇳Taipei, Taiwan
Cancer Center of Santa Barbara with Sansum Clinic
🇺🇸Santa Barbara, California, United States
California Cancer Associates in Research and Excellence
🇺🇸San Marcos, California, United States
Southern Cancer Center, P.C.
🇺🇸Daphne, Alabama, United States
Arizona Oncology Associates, P.C.
🇺🇸Tempe, Arizona, United States
St. Joseph Hospital
🇺🇸Orange, California, United States
Compassionate Cancer Care Medical Group Inc
🇺🇸Fountain Valley, California, United States
Memorial Hospital
🇺🇸Colorado Springs, Colorado, United States
UCLA Medical Center
🇺🇸Torrance, California, United States
Rocky Mountain Cancer Center
🇺🇸Lone Tree, Colorado, United States
Cancer Specialists of North Florida -St Augustine
🇺🇸Saint Augustine, Florida, United States
Medical Oncology Hematology Consultants, PA
🇺🇸Newark, Delaware, United States
Florida Cancer Specialists
🇺🇸West Palm Beach, Florida, United States
Ingalls Memorial Hospital
🇺🇸Harvey, Illinois, United States
HCA Midwest
🇺🇸Kansas City, Missouri, United States
Texas Oncology - Bedford
🇺🇸Bedford, Texas, United States
Texas Oncology Flower Mound
🇺🇸Flower Mound, Texas, United States
Texas Oncology - Medical City Dallas
🇺🇸Dallas, Texas, United States
Texas Oncology - Dallas Presbyterian Hospital
🇺🇸Dallas, Texas, United States
Abington Hematology Oncology Associates
🇺🇸Horsham, Pennsylvania, United States
Texas Oncology - Abilene
🇺🇸Abilene, Texas, United States
Sarah Cannon Research Institute SCRI
🇺🇸Nashville, Tennessee, United States
Texas Oncology - Amarillo
🇺🇸Amarillo, Texas, United States
Texas Oncology-Baylor Charles A. Sammons Cancer Center
🇺🇸Dallas, Texas, United States
Texas Oncology-Plano West
🇺🇸Plano, Texas, United States
Texas Oncology-Sherman
🇺🇸Sherman, Texas, United States
Centro Medico San Roque
🇦🇷San Miguel de Tucumán, Tucuman, Argentina
Hematology Oncology Associates of Fredericksburg Inc.
🇺🇸Fredericksburg, Virginia, United States
Texas Oncology- Mesquite
🇺🇸Mesquite, Texas, United States
Texas Oncology - Midland Allison Cancer Center
🇺🇸Midland, Texas, United States
Virginia Oncology Associates
🇺🇸Norfolk, Virginia, United States
Texas Oncology - Paris
🇺🇸Paris, Texas, United States
Texas Oncology - San Antonio Medical Center
🇺🇸San Antonio, Texas, United States
Texas Oncology-Plano East
🇺🇸Plano, Texas, United States
Tyler Cancer Center
🇺🇸Tyler, Texas, United States
US Oncology
🇺🇸The Woodlands, Texas, United States
Oncology and Hematology Associates of Southwest Virginia Inc
🇺🇸Salem, Virginia, United States
Intermountain Medical Center
🇺🇸Saint George, Utah, United States
Clinica Adventista de Belgrano
🇦🇷Ciudad Autonoma Buenos Aires, Argentina
Centro para la Atencion Integral del Paciente Oncologico
🇦🇷Tucumain, Argentina
Sanatorio Parque
🇦🇷Salta, Argentina
Clinique Saint Pierre Ottignies
🇧🇪Ottignies, Belgium
Instituto COI de Pesquisa Educação e Gestão
🇧🇷Rio de Janeiro, RJ, Brazil
Hospital de Base Fac de Medicina de Sao Jose do Rio Preto
🇧🇷Sao Jose Rio Preto, Sao Paulo, Brazil
Universitätsklinikum Graz
🇦🇹Graz, Steiermark, Austria
AKH
🇦🇹Wien, Austria
Hospital São Lucas - PUCRS - ONCOLOGY
🇧🇷Porto Alegre, Rio Grande Do Sul, Brazil
VZW REgional Ziekenhuis Jan Yperman
🇧🇪Ieper, Belgium
Hopital De Jolimont
🇧🇪Haine-St.- Paul, Belgium
Instituto de Cancer de Londrina
🇧🇷Londrina, Parana, Brazil
Faculdade de Medicina do ABC
🇧🇷Santo Andre, SP, Brazil
Núcleo de Oncologia da Bahia
🇧🇷Salvador, Bahia, Brazil
Istituto Tumori Fondazione G. Pascale IRCCS
🇮🇹Napoli, Naples, Italy
Universität Leipzig - Universitätsklinikum
🇩🇪Leipzig, Sachsen, Germany
Fundacao Antonio Prudente-Hosp. do Cancer AC Camargo
🇧🇷Sao Paulo, Brazil
Soc. Beneficente de Senhoras Hospital Sirio Libanes-Oncology
🇧🇷São Paulo, Brazil
E-DA Cancer Hospital
🇨🇳Kaohsiung, Taiwan
St. Vincenz-Krankenhaus GmbH-Frauen- und Kinderklinik St. Louise
🇩🇪Paderborn, Germany
Oncology Hematology West
🇺🇸Omaha, Nebraska, United States
Illinois Cancer Specialists-Niles
🇺🇸Niles, Illinois, United States
Broome Oncology LLC
🇺🇸Johnson City, New York, United States
Texas Oncology-Deke Slayton Cancer Center
🇺🇸Webster, Texas, United States
Texas Oncology-Wichital Falls Texoma Cancer Center
🇺🇸Wichita Falls, Texas, United States
Shenandoah Oncology, P.C.
🇺🇸Winchester, Virginia, United States
Pacific Cancer Care
🇺🇸Monterey, California, United States
Comprehensive Cancer Centers of the Desert
🇺🇸Palm Springs, California, United States
Beaver Medical Group
🇺🇸Highland, California, United States
Summit Cancer Care
🇺🇸Savannah, Georgia, United States
Cleveland Clinic of Florida
🇺🇸Weston, Florida, United States
York Hospital
🇺🇸York, Maine, United States
Valley Health System
🇺🇸Paramus, New Jersey, United States
Texas Oncology Cancer Center
🇺🇸Austin, Texas, United States
Charleston Hematology Oncology Associates
🇺🇸Charleston, South Carolina, United States
Texas Oncology P.A.
🇺🇸El Paso, Texas, United States
Texas Oncology-McKinney
🇺🇸McKinney, Texas, United States
The Center for Cancer and Blood Disorders
🇺🇸Fort Worth, Texas, United States
Texas Oncology - Marnie McFadden Ward Cancer Center
🇺🇸Dallas, Texas, United States
Texas Oncology-Memorial City
🇺🇸Houston, Texas, United States
Universitätsklinikum Salzburg
🇦🇹Salzburg, Austria
Texas Oncology - McAllen
🇺🇸McAllen, Texas, United States
INCA - Instituto Nacional Do Cancer
🇧🇷Rio de Janeiro, Brazil
Hospital Bruno Born de Lajeado
🇧🇷Lajeado, RS, Brazil
Koo Foundation Sun Yan-Sen Cancer Center
🇨🇳Taipei, Taiwan