Clinical trial NCT03988114: A Study of Abemaciclib (LY2835219) in Participants With HR+, HER2- Advanced Breast Cancer
Official title: A Single-Arm, Global, Phase 4 Study of Abemaciclib, a CDK 4 & 6 Inhibitor, in Combination With Nonsteroidal Aromatase Inhibitors (Anastrozole or Letrozole) in Participants With Hormone Receptor Positive, Human Epidermal Growth Factor Receptor 2 Negative Advanced Breast Cancer With Poor Prognostic Factors
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Metastatic Breast Cancer
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2019-06-17
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Progression Free Survival (PFS)
timeFrame: Baseline to Progressive Disease or Death from Any Cause (Estimated up to 26 Months)
measure: Objective Response Rate (ORR): Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR)
timeFrame: Baseline to Objective Disease Progression (Estimated up to 26 Months)
Secondary outcomes:
measure: Duration of Response (DoR)
timeFrame: Date of CR or PR to Date of Objective Disease Progression or Death from Any Cause (Estimated up to 26 Months)
measure: Disease Control Rate (DCR): Percentage of Participants with a Best Overall Response of CR, PR, or Stable Disease (SD)
timeFrame: Baseline to Objective Disease Progression (Estimated up to 26 Months)
measure: 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
timeFrame: Date of CR, PR or SD to 6 Months Post CR, PR or SD (Estimated up to 26 Months)
measure: Time to Response (TTR)
timeFrame: Baseline to Date of CR or PR (Estimated up to 26 Months)
Other outcomes:
Locations:
city: Daphne
country: United States
facility: Southern Cancer Center, P.C.
state: Alabama
city: Tempe
country: United States
facility: Arizona Oncology Associates, P.C.
state: Arizona
city: Fountain Valley
country: United States
facility: Compassionate Cancer Care Medical Group Inc
state: California
city: Fresno
country: United States
facility: California Cancer Associates Research and Excellence (cCARE)
state: California
city: Highland
country: United States
facility: Beaver Medical Group
state: California
city: Monterey
country: United States
facility: Pacific Cancer Care
state: California
city: Orange
country: United States
facility: St. Joseph Hospital
state: California
city: Palm Springs
country: United States
facility: Comprehensive Cancer Centers of the Desert
state: California
city: San Marcos
country: United States
facility: California Cancer Associates in Research and Excellence
state: California
city: Santa Barbara
country: United States
facility: Cancer Center of Santa Barbara with Sansum Clinic
state: California
city: Torrance
country: United States
facility: UCLA Medical Center
state: California
city: Colorado Springs
country: United States
facility: Memorial Hospital
state: Colorado
city: Lone Tree
country: United States
facility: Rocky Mountain Cancer Center
state: Colorado
city: Newark
country: United States
facility: Medical Oncology Hematology Consultants, PA
state: Delaware
city: Clearwater
country: United States
facility: BayCare Medical Group
state: Florida
city: Fort Myers
country: United States
facility: Florida Cancer Specialists
state: Florida
city: Pensacola
country: United States
facility: Woodlands Medical Specialists
state: Florida
city: Saint Augustine
country: United States
facility: Cancer Specialists of North Florida -St Augustine
state: Florida
city: Saint Petersburg
country: United States
facility: Florida Cancer Specialists
state: Florida
city: Tallahassee
country: United States
facility: Florida Cancer Specialists
state: Florida
city: West Palm Beach
country: United States
facility: Florida Cancer Specialists
state: Florida
city: Weston
country: United States
facility: Cleveland Clinic of Florida
state: Florida
city: Savannah
country: United States
facility: Summit Cancer Care
state: Georgia
city: Harvey
country: United States
facility: Ingalls Memorial Hospital
state: Illinois
city: Niles
country: United States
facility: Illinois Cancer Specialists-Niles
state: Illinois
city: Indianapolis
country: United States
facility: Community Health Network
state: Indiana
city: Lewiston
country: United States
facility: Central Maine Medical Center
state: Maine
city: York
country: United States
facility: York Hospital
state: Maine
city: Kansas City
country: United States
facility: HCA Midwest
state: Missouri
city: Omaha
country: United States
facility: Oncology Hematology West
state: Nebraska
city: Henderson
country: United States
facility: Comprehensive Cancer Centers of Nevada
state: Nevada
city: Paramus
country: United States
facility: Valley Health System
state: New Jersey
city: Johnson City
country: United States
facility: Broome Oncology LLC
state: New York
city: Horsham
country: United States
facility: Abington Hematology Oncology Associates
state: Pennsylvania
city: Charleston
country: United States
facility: Charleston Hematology Oncology Associates
state: South Carolina
city: Nashville
country: United States
facility: Sarah Cannon Research Institute SCRI
state: Tennessee
city: Nashville
country: United States
facility: Tennessee Oncology PLLC
state: Tennessee
city: Abilene
country: United States
facility: Texas Oncology - Abilene
state: Texas
city: Amarillo
country: United States
facility: Texas Oncology - Amarillo
state: Texas
city: Arlington
country: United States
facility: Texas Oncology-Arlington South
state: Texas
city: Austin
country: United States
facility: Texas Oncology Cancer Center
state: Texas
city: Bedford
country: United States
facility: Texas Oncology - Bedford
state: Texas
city: Dallas
country: United States
facility: Texas Oncology P.A.
state: Texas
city: Dallas
country: United States
facility: Texas Oncology - Medical City Dallas
state: Texas
city: Dallas
country: United States
facility: Texas Oncology - Dallas Presbyterian Hospital
state: Texas
city: Dallas
country: United States
facility: Texas Oncology-Baylor Charles A. Sammons Cancer Center
state: Texas
city: Dallas
country: United States
facility: Texas Oncology - Marnie McFadden Ward Cancer Center
state: Texas
city: El Paso
country: United States
facility: Texas Oncology P.A.
state: Texas
city: Flower Mound
country: United States
facility: Texas Oncology Flower Mound
state: Texas
city: Fort Worth
country: United States
facility: The Center for Cancer and Blood Disorders
state: Texas
city: Houston
country: United States
facility: Texas Oncology-Memorial City
state: Texas
city: Houston
country: United States
facility: Renovatio Clinical
state: Texas
city: McAllen
country: United States
facility: Texas Oncology - McAllen
state: Texas
city: McKinney
country: United States
facility: Texas Oncology-McKinney
state: Texas
city: Mesquite
country: United States
facility: Texas Oncology- Mesquite
state: Texas
city: Midland
country: United States
facility: Texas Oncology - Midland Allison Cancer Center
state: Texas
city: Paris
country: United States
facility: Texas Oncology - Paris
state: Texas
city: Plano
country: United States
facility: Texas Oncology-Plano East
state: Texas
city: Plano
country: United States
facility: Texas Oncology-Plano West
state: Texas
city: San Antonio
country: United States
facility: Texas Oncology - San Antonio Medical Center
state: Texas
city: Sherman
country: United States
facility: Texas Oncology-Sherman
state: Texas
city: The Woodlands
country: United States
facility: US Oncology
state: Texas
city: Tyler
country: United States
facility: Tyler Cancer Center
state: Texas
city: Webster
country: United States
facility: Texas Oncology-Deke Slayton Cancer Center
state: Texas
city: Wichita Falls
country: United States
facility: Texas Oncology-Wichital Falls Texoma Cancer Center
state: Texas
city: Saint George
country: United States
facility: Intermountain Medical Center
state: Utah
city: Fredericksburg
country: United States
facility: Hematology Oncology Associates of Fredericksburg Inc.
state: Virginia
city: Norfolk
country: United States
facility: Virginia Oncology Associates
state: Virginia
city: Salem
country: United States
facility: Oncology and Hematology Associates of Southwest Virginia Inc
state: Virginia
city: Winchester
country: United States
facility: Shenandoah Oncology, P.C.
state: Virginia
city: Berazategui
country: Argentina
facility: Centro de Oncologia e Investigacion Buenos Aires
state: Buenos Aires
city: Caba
country: Argentina
facility: CEMEDIC
state: Buenos Aires
city: Caba
country: Argentina
facility: CENIT Centro de Neurociencias, Investigación y Tratamiento
state: Ciudad Autonoma Buenos Aires
city: San Miguel de Tucumán
country: Argentina
facility: Centro Medico San Roque
state: Tucuman
city: Ciudad Autonoma Buenos Aires
country: Argentina
facility: Clinica Adventista de Belgrano
city: Salta
country: Argentina
facility: Sanatorio Parque
city: San Juan
country: Argentina
facility: Centro Polivalente de Asistencia e Inv. Clinica CER-San Juan
city: Tucumain
country: Argentina
facility: Centro para la Atencion Integral del Paciente Oncologico
city: Graz
country: Austria
facility: Universitätsklinikum Graz
state: Steiermark
city: Innsbruck
country: Austria
facility: Universitätsklinik Innsbruck
state: Tirol
city: Salzburg
country: Austria
facility: Universitätsklinikum Salzburg
city: Wien
country: Austria
facility: AKH
city: Brugge
country: Belgium
facility: Algemeen Ziekenhuis St Jan Brugge
city: Haine-St.- Paul
country: Belgium
facility: Hopital De Jolimont
city: Ieper
country: Belgium
facility: VZW REgional Ziekenhuis Jan Yperman
city: Ottignies
country: Belgium
facility: Clinique Saint Pierre Ottignies
city: Salvador
country: Brazil
facility: Núcleo de Oncologia da Bahia
state: Bahia
city: Londrina
country: Brazil
facility: Instituto de Cancer de Londrina
state: Parana
city: Ijui
country: Brazil
facility: Hospital de Caridade Ijui
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Hospital São Lucas - PUCRS - ONCOLOGY
state: Rio Grande Do Sul
city: Rio de Janeiro
country: Brazil
facility: Instituto COI de Pesquisa Educação e Gestão
state: RJ
city: Lajeado
country: Brazil
facility: Hospital Bruno Born de Lajeado
state: RS
city: Barretos
country: Brazil
facility: Fundação PIO XII
state: Sao Paulo
city: Sao Jose Rio Preto
country: Brazil
facility: Hospital de Base Fac de Medicina de Sao Jose do Rio Preto
state: Sao Paulo
city: Santo Andre
country: Brazil
facility: Faculdade de Medicina do ABC
state: SP
city: Ribeirao Preto
country: Brazil
facility: Hospital das Clinicas da FMRP
state: São Paulo
city: Rio de Janeiro
country: Brazil
facility: INCA - Instituto Nacional Do Cancer
city: Sao Paulo
country: Brazil
facility: Fundacao Antonio Prudente-Hosp. do Cancer AC Camargo
city: São Paulo
country: Brazil
facility: Soc. Beneficente de Senhoras Hospital Sirio Libanes-Oncology
city: São Paulo
country: Brazil
facility: Clin. Pesq.e Centro Estudos Oncologia Ginecológica e Mamária
city: São Paulo
country: Brazil
facility: Clinica Onco Star
city: Augsburg
country: Germany
facility: Hämatologisch-Onkologische Praxis Augsburg
state: Bavaria
city: Leipzig
country: Germany
facility: Universität Leipzig - Universitätsklinikum
state: Sachsen
city: Paderborn
country: Germany
facility: St. Vincenz-Krankenhaus GmbH-Frauen- und Kinderklinik St. Louise
city: Napoli
country: Italy
facility: Istituto Tumori Fondazione G. Pascale IRCCS
state: Naples
city: Candiolo
country: Italy
facility: Fondazione Piemonte l'Oncologia-Istituto Ricerca Cura Cancro
state: Torino
city: Bologna
country: Italy
facility: Policlinico S. Orsola Malpighi - Universita di Bologna
city: Genova
country: Italy
facility: Azienda Ospedaliera Universitaria Ospedale San Martino di Genova
city: Milano
country: Italy
facility: IRCCS Ospedale San Raffaele
city: Padova
country: Italy
facility: Istituto Oncologico Veneto
city: Udine
country: Italy
facility: Centro di Riferimento Oncologico
city: Bayamon
country: Puerto Rico
facility: Puerto Rico Hematology/Oncology Group
city: Ponce
country: Puerto Rico
facility: Ad-Vance Medical Research
city: Kaohsiung
country: Taiwan
facility: E-DA Cancer Hospital
city: Taichung
country: Taiwan
facility: China Medical University Hospital
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital
city: Taipei
country: Taiwan
facility: MacKay Memorial Hospital
city: Taipei
country: Taiwan
facility: Koo Foundation Sun Yan-Sen Cancer Center
Study officials:
affiliation: Eli Lilly and Company
name: 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)
role: STUDY_DIRECTOR
References: