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

Primary Purpose

Metastatic Breast Cancer

Status
Withdrawn
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Abemaciclib
Nonsteroidal Aromatase Inhibitor (NSAI)
Sponsored by
Eli Lilly and Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Breast Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Southern Cancer Center, P.C.
  • Arizona Oncology Associates, P.C.
  • Compassionate Cancer Care Medical Group Inc
  • California Cancer Associates Research and Excellence (cCARE)
  • Beaver Medical Group
  • Pacific Cancer Care
  • St. Joseph Hospital
  • Comprehensive Cancer Centers of the Desert
  • California Cancer Associates in Research and Excellence
  • Cancer Center of Santa Barbara with Sansum Clinic
  • UCLA Medical Center
  • Memorial Hospital
  • Rocky Mountain Cancer Center
  • Medical Oncology Hematology Consultants, PA
  • BayCare Medical Group
  • Florida Cancer Specialists
  • Woodlands Medical Specialists
  • Cancer Specialists of North Florida -St Augustine
  • Florida Cancer Specialists
  • Florida Cancer Specialists
  • Florida Cancer Specialists
  • Cleveland Clinic of Florida
  • Summit Cancer Care
  • Ingalls Memorial Hospital
  • Illinois Cancer Specialists-Niles
  • Community Health Network
  • Central Maine Medical Center
  • York Hospital
  • HCA Midwest
  • Oncology Hematology West
  • Comprehensive Cancer Centers of Nevada
  • Valley Health System
  • Broome Oncology LLC
  • Abington Hematology Oncology Associates
  • Charleston Hematology Oncology Associates
  • Sarah Cannon Research Institute SCRI
  • Tennessee Oncology PLLC
  • Texas Oncology - Abilene
  • Texas Oncology - Amarillo
  • Texas Oncology-Arlington South
  • Texas Oncology Cancer Center
  • Texas Oncology - Bedford
  • Texas Oncology P.A.
  • Texas Oncology - Medical City Dallas
  • Texas Oncology - Dallas Presbyterian Hospital
  • Texas Oncology-Baylor Charles A. Sammons Cancer Center
  • Texas Oncology - Marnie McFadden Ward Cancer Center
  • Texas Oncology P.A.
  • Texas Oncology Flower Mound
  • The Center for Cancer and Blood Disorders
  • Texas Oncology-Memorial City
  • Renovatio Clinical
  • Texas Oncology - McAllen
  • Texas Oncology-McKinney
  • Texas Oncology- Mesquite
  • Texas Oncology - Midland Allison Cancer Center
  • Texas Oncology - Paris
  • Texas Oncology-Plano East
  • Texas Oncology-Plano West
  • Texas Oncology - San Antonio Medical Center
  • Texas Oncology-Sherman
  • US Oncology
  • Tyler Cancer Center
  • Texas Oncology-Deke Slayton Cancer Center
  • Texas Oncology-Wichital Falls Texoma Cancer Center
  • Intermountain Medical Center
  • Hematology Oncology Associates of Fredericksburg Inc.
  • Virginia Oncology Associates
  • Oncology and Hematology Associates of Southwest Virginia Inc
  • Shenandoah Oncology, P.C.
  • Centro de Oncologia e Investigacion Buenos Aires
  • CEMEDIC
  • CENIT Centro de Neurociencias, Investigación y Tratamiento
  • Centro Medico San Roque
  • Clinica Adventista de Belgrano
  • Sanatorio Parque
  • Centro Polivalente de Asistencia e Inv. Clinica CER-San Juan
  • Centro para la Atencion Integral del Paciente Oncologico
  • Universitätsklinikum Graz
  • Universitätsklinik Innsbruck
  • Universitätsklinikum Salzburg
  • AKH
  • Algemeen Ziekenhuis St Jan Brugge
  • Hopital De Jolimont
  • VZW REgional Ziekenhuis Jan Yperman
  • Clinique Saint Pierre Ottignies
  • Núcleo de Oncologia da Bahia
  • Instituto de Cancer de Londrina
  • Hospital de Caridade Ijui
  • Hospital São Lucas - PUCRS - ONCOLOGY
  • Instituto COI de Pesquisa Educação e Gestão
  • Hospital Bruno Born de Lajeado
  • Fundação PIO XII
  • Hospital de Base Fac de Medicina de Sao Jose do Rio Preto
  • Faculdade de Medicina do ABC
  • Hospital das Clinicas da FMRP
  • INCA - Instituto Nacional Do Cancer
  • Fundacao Antonio Prudente-Hosp. do Cancer AC Camargo
  • Soc. Beneficente de Senhoras Hospital Sirio Libanes-Oncology
  • Clin. Pesq.e Centro Estudos Oncologia Ginecológica e Mamária
  • Clinica Onco Star
  • Hämatologisch-Onkologische Praxis Augsburg
  • Universität Leipzig - Universitätsklinikum
  • St. Vincenz-Krankenhaus GmbH-Frauen- und Kinderklinik St. Louise
  • Istituto Tumori Fondazione G. Pascale IRCCS
  • Fondazione Piemonte l'Oncologia-Istituto Ricerca Cura Cancro
  • Policlinico S. Orsola Malpighi - Universita di Bologna
  • Azienda Ospedaliera Universitaria Ospedale San Martino di Genova
  • IRCCS Ospedale San Raffaele
  • Istituto Oncologico Veneto
  • Centro di Riferimento Oncologico
  • Puerto Rico Hematology/Oncology Group
  • Ad-Vance Medical Research
  • E-DA Cancer Hospital
  • China Medical University Hospital
  • Taichung Veterans General Hospital
  • National Cheng Kung University Hospital
  • MacKay Memorial Hospital
  • Koo Foundation Sun Yan-Sen Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Abemaciclib + NSAI

Arm Description

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

Outcomes

Primary Outcome Measures

Progression Free Survival (PFS)
PFS
Objective Response Rate (ORR): Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR)
ORR

Secondary Outcome Measures

Duration of Response (DoR)
DoR
Disease Control Rate (DCR): Percentage of Participants with a Best Overall Response of CR, PR, or Stable Disease (SD)
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
CBR
Time to Response (TTR)
TTR

Full Information

First Posted
June 12, 2019
Last Updated
September 4, 2019
Sponsor
Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT03988114
Brief Title
A Study of Abemaciclib (LY2835219) in Participants With HR+, HER2- Advanced Breast Cancer
Acronym
proMONARCH
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

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Withdrawn
Why Stopped
Strategic decision due to emerging new data for patients with HR+, HER2- metastatic breast cancer.
Study Start Date
September 16, 2019 (Anticipated)
Primary Completion Date
March 23, 2022 (Anticipated)
Study Completion Date
March 23, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eli Lilly and Company

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Breast Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Abemaciclib + NSAI
Arm Type
Experimental
Arm Description
Abemaciclib given orally and nonsteroidal aromatase inhibitor (NSAI) of physician's choice (anastrazole or letrozole) given orally.
Intervention Type
Drug
Intervention Name(s)
Abemaciclib
Other Intervention Name(s)
LY2835219
Intervention Description
Administered orally
Intervention Type
Drug
Intervention Name(s)
Nonsteroidal Aromatase Inhibitor (NSAI)
Intervention Description
Letrozole administered orally or anastrozole administered orally (physician choice)
Primary Outcome Measure Information:
Title
Progression Free Survival (PFS)
Description
PFS
Time Frame
Baseline to Progressive Disease or Death from Any Cause (Estimated up to 26 Months)
Title
Objective Response Rate (ORR): Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR)
Description
ORR
Time Frame
Baseline to Objective Disease Progression (Estimated up to 26 Months)
Secondary Outcome Measure Information:
Title
Duration of Response (DoR)
Description
DoR
Time Frame
Date of CR or PR to Date of Objective Disease Progression or Death from Any Cause (Estimated up to 26 Months)
Title
Disease Control Rate (DCR): Percentage of Participants with a Best Overall Response of CR, PR, or Stable Disease (SD)
Description
DCR
Time Frame
Baseline to Objective Disease Progression (Estimated up to 26 Months)
Title
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
Description
CBR
Time Frame
Date of CR, PR or SD to 6 Months Post CR, PR or SD (Estimated up to 26 Months)
Title
Time to Response (TTR)
Description
TTR
Time Frame
Baseline to Date of CR or PR (Estimated up to 26 Months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
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)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
Southern Cancer Center, P.C.
City
Daphne
State/Province
Alabama
ZIP/Postal Code
36526
Country
United States
Facility Name
Arizona Oncology Associates, P.C.
City
Tempe
State/Province
Arizona
ZIP/Postal Code
85284
Country
United States
Facility Name
Compassionate Cancer Care Medical Group Inc
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
Country
United States
Facility Name
California Cancer Associates Research and Excellence (cCARE)
City
Fresno
State/Province
California
ZIP/Postal Code
93720
Country
United States
Facility Name
Beaver Medical Group
City
Highland
State/Province
California
ZIP/Postal Code
92346
Country
United States
Facility Name
Pacific Cancer Care
City
Monterey
State/Province
California
ZIP/Postal Code
93940
Country
United States
Facility Name
St. Joseph Hospital
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Comprehensive Cancer Centers of the Desert
City
Palm Springs
State/Province
California
ZIP/Postal Code
92262
Country
United States
Facility Name
California Cancer Associates in Research and Excellence
City
San Marcos
State/Province
California
ZIP/Postal Code
92069
Country
United States
Facility Name
Cancer Center of Santa Barbara with Sansum Clinic
City
Santa Barbara
State/Province
California
ZIP/Postal Code
93105
Country
United States
Facility Name
UCLA Medical Center
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
Facility Name
Memorial Hospital
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80909
Country
United States
Facility Name
Rocky Mountain Cancer Center
City
Lone Tree
State/Province
Colorado
ZIP/Postal Code
80124
Country
United States
Facility Name
Medical Oncology Hematology Consultants, PA
City
Newark
State/Province
Delaware
ZIP/Postal Code
19713
Country
United States
Facility Name
BayCare Medical Group
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33756
Country
United States
Facility Name
Florida Cancer Specialists
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33901
Country
United States
Facility Name
Woodlands Medical Specialists
City
Pensacola
State/Province
Florida
ZIP/Postal Code
32503
Country
United States
Facility Name
Cancer Specialists of North Florida -St Augustine
City
Saint Augustine
State/Province
Florida
ZIP/Postal Code
32086
Country
United States
Facility Name
Florida Cancer Specialists
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33705
Country
United States
Facility Name
Florida Cancer Specialists
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32308
Country
United States
Facility Name
Florida Cancer Specialists
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33401
Country
United States
Facility Name
Cleveland Clinic of Florida
City
Weston
State/Province
Florida
ZIP/Postal Code
33331
Country
United States
Facility Name
Summit Cancer Care
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31404
Country
United States
Facility Name
Ingalls Memorial Hospital
City
Harvey
State/Province
Illinois
ZIP/Postal Code
60426
Country
United States
Facility Name
Illinois Cancer Specialists-Niles
City
Niles
State/Province
Illinois
ZIP/Postal Code
60714
Country
United States
Facility Name
Community Health Network
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46219
Country
United States
Facility Name
Central Maine Medical Center
City
Lewiston
State/Province
Maine
ZIP/Postal Code
04240
Country
United States
Facility Name
York Hospital
City
York
State/Province
Maine
ZIP/Postal Code
03909
Country
United States
Facility Name
HCA Midwest
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64132
Country
United States
Facility Name
Oncology Hematology West
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68130
Country
United States
Facility Name
Comprehensive Cancer Centers of Nevada
City
Henderson
State/Province
Nevada
ZIP/Postal Code
89052
Country
United States
Facility Name
Valley Health System
City
Paramus
State/Province
New Jersey
ZIP/Postal Code
07652
Country
United States
Facility Name
Broome Oncology LLC
City
Johnson City
State/Province
New York
ZIP/Postal Code
13790
Country
United States
Facility Name
Abington Hematology Oncology Associates
City
Horsham
State/Province
Pennsylvania
ZIP/Postal Code
19044
Country
United States
Facility Name
Charleston Hematology Oncology Associates
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29414
Country
United States
Facility Name
Sarah Cannon Research Institute SCRI
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Tennessee Oncology PLLC
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Texas Oncology - Abilene
City
Abilene
State/Province
Texas
ZIP/Postal Code
79606
Country
United States
Facility Name
Texas Oncology - Amarillo
City
Amarillo
State/Province
Texas
ZIP/Postal Code
79106
Country
United States
Facility Name
Texas Oncology-Arlington South
City
Arlington
State/Province
Texas
ZIP/Postal Code
76014
Country
United States
Facility Name
Texas Oncology Cancer Center
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Facility Name
Texas Oncology - Bedford
City
Bedford
State/Province
Texas
ZIP/Postal Code
76022
Country
United States
Facility Name
Texas Oncology P.A.
City
Dallas
State/Province
Texas
ZIP/Postal Code
75203
Country
United States
Facility Name
Texas Oncology - Medical City Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
Texas Oncology - Dallas Presbyterian Hospital
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Texas Oncology-Baylor Charles A. Sammons Cancer Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
Texas Oncology - Marnie McFadden Ward Cancer Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
77702
Country
United States
Facility Name
Texas Oncology P.A.
City
El Paso
State/Province
Texas
ZIP/Postal Code
79902
Country
United States
Facility Name
Texas Oncology Flower Mound
City
Flower Mound
State/Province
Texas
ZIP/Postal Code
75028
Country
United States
Facility Name
The Center for Cancer and Blood Disorders
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
Texas Oncology-Memorial City
City
Houston
State/Province
Texas
ZIP/Postal Code
77024
Country
United States
Facility Name
Renovatio Clinical
City
Houston
State/Province
Texas
ZIP/Postal Code
77056
Country
United States
Facility Name
Texas Oncology - McAllen
City
McAllen
State/Province
Texas
ZIP/Postal Code
78503
Country
United States
Facility Name
Texas Oncology-McKinney
City
McKinney
State/Province
Texas
ZIP/Postal Code
75771
Country
United States
Facility Name
Texas Oncology- Mesquite
City
Mesquite
State/Province
Texas
ZIP/Postal Code
75150
Country
United States
Facility Name
Texas Oncology - Midland Allison Cancer Center
City
Midland
State/Province
Texas
ZIP/Postal Code
79701
Country
United States
Facility Name
Texas Oncology - Paris
City
Paris
State/Province
Texas
ZIP/Postal Code
75460
Country
United States
Facility Name
Texas Oncology-Plano East
City
Plano
State/Province
Texas
ZIP/Postal Code
75075
Country
United States
Facility Name
Texas Oncology-Plano West
City
Plano
State/Province
Texas
ZIP/Postal Code
75093
Country
United States
Facility Name
Texas Oncology - San Antonio Medical Center
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78217
Country
United States
Facility Name
Texas Oncology-Sherman
City
Sherman
State/Province
Texas
ZIP/Postal Code
75090-0504
Country
United States
Facility Name
US Oncology
City
The Woodlands
State/Province
Texas
ZIP/Postal Code
77380
Country
United States
Facility Name
Tyler Cancer Center
City
Tyler
State/Province
Texas
ZIP/Postal Code
75702
Country
United States
Facility Name
Texas Oncology-Deke Slayton Cancer Center
City
Webster
State/Province
Texas
ZIP/Postal Code
77598-4219
Country
United States
Facility Name
Texas Oncology-Wichital Falls Texoma Cancer Center
City
Wichita Falls
State/Province
Texas
ZIP/Postal Code
76310
Country
United States
Facility Name
Intermountain Medical Center
City
Saint George
State/Province
Utah
ZIP/Postal Code
84790
Country
United States
Facility Name
Hematology Oncology Associates of Fredericksburg Inc.
City
Fredericksburg
State/Province
Virginia
ZIP/Postal Code
22408
Country
United States
Facility Name
Virginia Oncology Associates
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Facility Name
Oncology and Hematology Associates of Southwest Virginia Inc
City
Salem
State/Province
Virginia
ZIP/Postal Code
24153
Country
United States
Facility Name
Shenandoah Oncology, P.C.
City
Winchester
State/Province
Virginia
ZIP/Postal Code
22601
Country
United States
Facility Name
Centro de Oncologia e Investigacion Buenos Aires
City
Berazategui
State/Province
Buenos Aires
ZIP/Postal Code
B1884BBF
Country
Argentina
Facility Name
CEMEDIC
City
Caba
State/Province
Buenos Aires
ZIP/Postal Code
C1440CFD
Country
Argentina
Facility Name
CENIT Centro de Neurociencias, Investigación y Tratamiento
City
Caba
State/Province
Ciudad Autonoma Buenos Aires
ZIP/Postal Code
C1125ABD
Country
Argentina
Facility Name
Centro Medico San Roque
City
San Miguel de Tucumán
State/Province
Tucuman
ZIP/Postal Code
T4000IAK
Country
Argentina
Facility Name
Clinica Adventista de Belgrano
City
Ciudad Autonoma Buenos Aires
ZIP/Postal Code
C1430EGF
Country
Argentina
Facility Name
Sanatorio Parque
City
Salta
ZIP/Postal Code
4400
Country
Argentina
Facility Name
Centro Polivalente de Asistencia e Inv. Clinica CER-San Juan
City
San Juan
ZIP/Postal Code
J5402DIL
Country
Argentina
Facility Name
Centro para la Atencion Integral del Paciente Oncologico
City
Tucumain
ZIP/Postal Code
4000
Country
Argentina
Facility Name
Universitätsklinikum Graz
City
Graz
State/Province
Steiermark
ZIP/Postal Code
8036
Country
Austria
Facility Name
Universitätsklinik Innsbruck
City
Innsbruck
State/Province
Tirol
ZIP/Postal Code
6020
Country
Austria
Facility Name
Universitätsklinikum Salzburg
City
Salzburg
ZIP/Postal Code
5020
Country
Austria
Facility Name
AKH
City
Wien
ZIP/Postal Code
1090
Country
Austria
Facility Name
Algemeen Ziekenhuis St Jan Brugge
City
Brugge
ZIP/Postal Code
8000
Country
Belgium
Facility Name
Hopital De Jolimont
City
Haine-St.- Paul
ZIP/Postal Code
7100
Country
Belgium
Facility Name
VZW REgional Ziekenhuis Jan Yperman
City
Ieper
ZIP/Postal Code
8900
Country
Belgium
Facility Name
Clinique Saint Pierre Ottignies
City
Ottignies
ZIP/Postal Code
1340
Country
Belgium
Facility Name
Núcleo de Oncologia da Bahia
City
Salvador
State/Province
Bahia
ZIP/Postal Code
41170
Country
Brazil
Facility Name
Instituto de Cancer de Londrina
City
Londrina
State/Province
Parana
ZIP/Postal Code
86015-520
Country
Brazil
Facility Name
Hospital de Caridade Ijui
City
Ijui
State/Province
Rio Grande Do Sul
ZIP/Postal Code
98700 000
Country
Brazil
Facility Name
Hospital São Lucas - PUCRS - ONCOLOGY
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90610-000
Country
Brazil
Facility Name
Instituto COI de Pesquisa Educação e Gestão
City
Rio de Janeiro
State/Province
RJ
ZIP/Postal Code
22793-080
Country
Brazil
Facility Name
Hospital Bruno Born de Lajeado
City
Lajeado
State/Province
RS
ZIP/Postal Code
95900-000
Country
Brazil
Facility Name
Fundação PIO XII
City
Barretos
State/Province
Sao Paulo
ZIP/Postal Code
14784700
Country
Brazil
Facility Name
Hospital de Base Fac de Medicina de Sao Jose do Rio Preto
City
Sao Jose Rio Preto
State/Province
Sao Paulo
ZIP/Postal Code
15090-000
Country
Brazil
Facility Name
Faculdade de Medicina do ABC
City
Santo Andre
State/Province
SP
ZIP/Postal Code
09060-020
Country
Brazil
Facility Name
Hospital das Clinicas da FMRP
City
Ribeirao Preto
State/Province
São Paulo
ZIP/Postal Code
14048-900
Country
Brazil
Facility Name
INCA - Instituto Nacional Do Cancer
City
Rio de Janeiro
ZIP/Postal Code
20231
Country
Brazil
Facility Name
Fundacao Antonio Prudente-Hosp. do Cancer AC Camargo
City
Sao Paulo
ZIP/Postal Code
01509-900
Country
Brazil
Facility Name
Soc. Beneficente de Senhoras Hospital Sirio Libanes-Oncology
City
São Paulo
ZIP/Postal Code
01246
Country
Brazil
Facility Name
Clin. Pesq.e Centro Estudos Oncologia Ginecológica e Mamária
City
São Paulo
ZIP/Postal Code
01317-000
Country
Brazil
Facility Name
Clinica Onco Star
City
São Paulo
ZIP/Postal Code
04501-000
Country
Brazil
Facility Name
Hämatologisch-Onkologische Praxis Augsburg
City
Augsburg
State/Province
Bavaria
ZIP/Postal Code
86150
Country
Germany
Facility Name
Universität Leipzig - Universitätsklinikum
City
Leipzig
State/Province
Sachsen
ZIP/Postal Code
04103
Country
Germany
Facility Name
St. Vincenz-Krankenhaus GmbH-Frauen- und Kinderklinik St. Louise
City
Paderborn
ZIP/Postal Code
33098
Country
Germany
Facility Name
Istituto Tumori Fondazione G. Pascale IRCCS
City
Napoli
State/Province
Naples
ZIP/Postal Code
80131
Country
Italy
Facility Name
Fondazione Piemonte l'Oncologia-Istituto Ricerca Cura Cancro
City
Candiolo
State/Province
Torino
ZIP/Postal Code
10060
Country
Italy
Facility Name
Policlinico S. Orsola Malpighi - Universita di Bologna
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria Ospedale San Martino di Genova
City
Genova
ZIP/Postal Code
16132
Country
Italy
Facility Name
IRCCS Ospedale San Raffaele
City
Milano
ZIP/Postal Code
20132
Country
Italy
Facility Name
Istituto Oncologico Veneto
City
Padova
ZIP/Postal Code
35128
Country
Italy
Facility Name
Centro di Riferimento Oncologico
City
Udine
ZIP/Postal Code
33100
Country
Italy
Facility Name
Puerto Rico Hematology/Oncology Group
City
Bayamon
ZIP/Postal Code
00959
Country
Puerto Rico
Facility Name
Ad-Vance Medical Research
City
Ponce
ZIP/Postal Code
00717
Country
Puerto Rico
Facility Name
E-DA Cancer Hospital
City
Kaohsiung
ZIP/Postal Code
82445
Country
Taiwan
Facility Name
China Medical University Hospital
City
Taichung
ZIP/Postal Code
40447
Country
Taiwan
Facility Name
Taichung Veterans General Hospital
City
Taichung
ZIP/Postal Code
40705, ROC
Country
Taiwan
Facility Name
National Cheng Kung University Hospital
City
Tainan
ZIP/Postal Code
704
Country
Taiwan
Facility Name
MacKay Memorial Hospital
City
Taipei
ZIP/Postal Code
10449
Country
Taiwan
Facility Name
Koo Foundation Sun Yan-Sen Cancer Center
City
Taipei
ZIP/Postal Code
11259
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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 URL
http://www.clinicalstudydatarequest.com
Links:
URL
https://www.lillytrialguide.com/en-US/studies/metastatic-breast-cancer/JPCX
Description
A Study of Abemaciclib (LY2835219) in Participants With HR+, HER2- Advanced Breast Cancer

Learn more about this trial

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

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