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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04975308




Registration number
NCT04975308
Ethics application status
Date submitted
22/07/2021
Date registered
23/07/2021

Titles & IDs
Public title
A Study of Imlunestrant, Investigator's Choice of Endocrine Therapy, and Imlunestrant Plus Abemaciclib in Participants With ER+, HER2- Advanced Breast Cancer
Scientific title
EMBER-3: A Phase 3, Randomized, Open-Label Study of Imlunestrant, Investigator's Choice of Endocrine Therapy, and Imlunestrant Plus Abemaciclib in Patients With Estrogen Receptor Positive, HER2 Negative Locally Advanced or Metastatic Breast Cancer Previously Treated With Endocrine Therapy
Secondary ID [1] 0 0
J2J-OX-JZLC
Secondary ID [2] 0 0
18175
Universal Trial Number (UTN)
Trial acronym
EMBER-3
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Neoplasms 0 0
Neoplasm Metastasis 0 0
Condition category
Condition code
Cancer 0 0 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Imlunestrant
Treatment: Drugs - Exemestane
Treatment: Drugs - Fulvestrant
Treatment: Drugs - Abemaciclib

Experimental: Imlunestrant - Imlunestrant administered orally.

Active comparator: Investigator's Choice of Endocrine Therapy - Investigator's choice of exemestane administered orally or fulvestrant administered intramuscularly (IM). See local approved label for additional instructions.

Experimental: Imlunestrant plus Abemaciclib - Imlunestrant plus abemaciclib administered orally.


Treatment: Drugs: Imlunestrant
Administered orally.

Treatment: Drugs: Exemestane
Administered orally.

Treatment: Drugs: Fulvestrant
Administered IM.

Treatment: Drugs: Abemaciclib
Administered orally.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression Free Survival (PFS) in the Intent-to-Treat (IIT) Population
Timepoint [1] 0 0
Randomization to the date of first documented progression of disease or death from any cause (estimated as up to 3 years)
Primary outcome [2] 0 0
PFS in the Estrogen Receptor 1 (ESR1)-mutation Detected Population
Timepoint [2] 0 0
Randomization to the date of first documented progression of disease or death from any cause (estimated as up to 3 years)
Secondary outcome [1] 0 0
Overall Survival (OS) in the IIT Population
Timepoint [1] 0 0
Randomization until death from any cause (estimated as up to 5 years)
Secondary outcome [2] 0 0
OS in the ESR1-mutation Detected Population
Timepoint [2] 0 0
Randomization until death from any cause (estimated as up to 5 years)
Secondary outcome [3] 0 0
Objective Response Rate (ORR): Percentage of Participants Who Achieve a Confirmed Best Overall Response of Complete Response (CR) or Partial Response (PR)
Timepoint [3] 0 0
Randomization until measured progressive disease (estimated as up to 1 year)
Secondary outcome [4] 0 0
Duration of Response (DoR)
Timepoint [4] 0 0
Date of CR or PR to date of disease progression or death due to any cause (estimated up to 3 years)
Secondary outcome [5] 0 0
Clinical Benefit Rate (CBR): Percentage of Participants Who Achieve a Best Overall Response of CR, PR or Stable Disease for Greater than or Equal to (=) 24 Weeks
Timepoint [5] 0 0
Randomization until measured progressive disease (estimated as up to 1 year)
Secondary outcome [6] 0 0
Progression Free Survival (PFS)
Timepoint [6] 0 0
Randomization to the date of first documented progression of disease or death from any cause(estimated as up to 3 years)
Secondary outcome [7] 0 0
Patient Reported Outcomes (PRO): Time to Worsening of "Worst Pain"
Timepoint [7] 0 0
Screening through follow-up (estimated as up to 3 years)
Secondary outcome [8] 0 0
Pharmacokinetics (PK): Steady State Plasma Concentrations of Imlunestrant
Timepoint [8] 0 0
Cycle 2 to Cycle 4 (cycle = 28 days)
Secondary outcome [9] 0 0
PK: Steady State Plasma Concentrations of Imlunestrant and Abemaciclib
Timepoint [9] 0 0
Cycle 2 to Cycle 4 (cycle = 28 days)

Eligibility
Key inclusion criteria
* Have a diagnosis of ER+, HER2- locally advanced or metastatic breast cancer
* Have disease that has demonstrated progression on or after an aromatase inhibitor alone or in combination with a cyclin-dependent kinase (CDK)4/6 inhibitor

-- Participants are expected to have received prior treatment with a CDK4/6 inhibitor, if this treatment is approved and can be reimbursed
* Must be deemed appropriate for treatment with endocrine therapy
* If female, have a postmenopausal status by natural or surgical means or by ovarian function suppression
* Have RECIST evaluable disease (measurable disease and/or nonmeasurable bone-only disease)
* Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group scale (Oken et al. 1982)
* Have adequate renal, hematologic, and hepatic organ function
* Must be able to swallow capsules/tablets
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Have received prior treatment with chemotherapy (except for neoadjuvant/ adjuvant chemotherapy), fulvestrant, or any investigational-ER-directed therapy (including SERDs and non-SERDs), any PI3K-, mTOR- or AKT- inhibitor
* Have visceral crisis, lymphangitic spread within the lung, or any evidence of leptomeningeal disease.
* Have symptomatic or untreated brain metastasis.
* Have serious preexisting medical conditions that, in the judgment of the investigator, would preclude participation in this study
* Known allergic reaction against any of the components of the study treatment

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
4/10/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/08/2027
Actual
Sample size
Target
Accrual to date
Final
866
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
St Vincent's Hospital - Darlinghurst
Recruitment hospital [2] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [3] 0 0
Cancer Research SA - Adelaide
Recruitment hospital [4] 0 0
Box Hill Hospital - Box Hill
Recruitment hospital [5] 0 0
Maroondah Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [3] 0 0
5000 - Adelaide
Recruitment postcode(s) [4] 0 0
3128 - Box Hill
Recruitment postcode(s) [5] 0 0
3135 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
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Arizona
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California
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Colorado
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Florida
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Hawaii
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Illinois
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Indiana
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Kentucky
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Mississippi
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New Jersey
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New York
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North Carolina
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Ohio
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South Dakota
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Tennessee
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Texas
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United States of America
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Utah
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United States of America
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Vermont
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Argentina
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Buenos Aires
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Argentina
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Ciudad Autónoma De Buenos Aires
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Argentina
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Córdoba
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Argentina
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Río Negro
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Argentina
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San Juan
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Argentina
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Santiago del Estero
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Austria
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Steiermark
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Austria
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Wien
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Austria
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Salzburg
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Belgium
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Antwerpen
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Belgium
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Bruxelles-Capitale, Région De
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Belgium
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Oost-Vlaanderen
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Belgium
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Vlaams-Brabant
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Belgium
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West-Vlaanderen
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Belgium
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Namur
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Brazil
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Paraná
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Brazil
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São Paulo
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Anhui
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Beijing
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Guangdong
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China
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Heilongjiang
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China
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Henan
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China
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Hubei
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China
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Hunan
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China
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Jiangsu
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China
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Jiangxi
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China
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Jilin
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China
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Shaanxi
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China
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Shandong
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China
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Sichuan
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China
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Tianjin
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China
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Zhejiang
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Czechia
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Beroun
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Czechia
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Praha 10
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Czechia
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Praha 4
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Czechia
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Praha 8
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Czechia
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Príbram
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France
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Alsace
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France
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Centre
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France
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Doubs
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France
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Hauts-de-Seine
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France
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Languedoc-Roussillon
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France
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Pays-de-la-Loire
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France
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Pyrénées-Atlantiques
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France
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Paris
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France
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Vandoeuvre-lès-Nancy
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Germany
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Baden-Württemberg
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Germany
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Bayern
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Germany
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Hessen
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Germany
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Niedersachsen
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Germany
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Nordrhein-Westfalen
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Germany
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Schleswig-Holstein
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Greece
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Attikí
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Greece
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Irakleío
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Greece
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Thessaloníki
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Greece
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Thessalía
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India
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Karnataka
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India
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Kerala
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India
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Maharashtra
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India
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Telangana
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Italy
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Campania
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Italy
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Friuli-Venezia Giulia
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Italy
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Lazio
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Italy
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Liguria
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Italy
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Toscana
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Italy
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Padova
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Japan
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Aichi
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Japan
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Chiba
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Ehime
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Japan
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Fukuoka
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Japan
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Gunma
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Japan
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Hokkaido
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Hyogo
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Ibaraki
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Japan
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Kanagawa
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Japan
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Nagano
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Japan
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Niigata
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Japan
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Tokyo
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Japan
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Hiroshima
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Kagoshima
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Japan
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Kumamoto
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Japan
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Osaka
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Japan
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Shizuoka
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Korea, Republic of
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Chungcheongnam-do [Chungnam]
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Korea, Republic of
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Incheon-gwangyeoksi [Incheon]
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Korea, Republic of
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Kyonggi-do
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Korea, Republic of
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Kyongsangbuk-do
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Korea, Republic of
State/province [107] 0 0
Pusan-Kwangyokshi
Country [108] 0 0
Korea, Republic of
State/province [108] 0 0
Seoul-teukbyeolsi [Seoul]
Country [109] 0 0
Korea, Republic of
State/province [109] 0 0
Taegu-Kwangyokshi
Country [110] 0 0
Mexico
State/province [110] 0 0
Coahuila
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Mexico
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Distrito Federal
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Mexico
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Nuevo León
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Mexico
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Chihuahua
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Mexico
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Oaxaca
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Mexico
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Puebla
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Netherlands
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Fryslân
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Netherlands
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Limburg
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Netherlands
State/province [118] 0 0
Zuid-Holland
Country [119] 0 0
Russian Federation
State/province [119] 0 0
Kalužskaja Oblast'
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Russian Federation
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Volgogradskaya Oblast'
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Russian Federation
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Saint Petersburg
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Spain
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Barcelona [Barcelona]
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Spain
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Catalunya [Cataluña]
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Spain
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Extremadura
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Spain
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Lleida [Lérida]
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Spain
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Madrid, Comunidad De
Country [127] 0 0
Spain
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Santa Cruz De Tenerife
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Spain
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Valenciana, Comunitat
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Spain
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València
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Spain
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Granada
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Spain
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Madrid
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Spain
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Sevilla
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Taiwan
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Tainan
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Taiwan
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Taichung
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Taiwan
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Taipei
Country [136] 0 0
Turkey
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Istanbul
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Turkey
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Adana
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Turkey
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Ankara
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Turkey
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Antalya
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Turkey
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Diyarbakir
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Turkey
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Edirne
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Turkey
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Izmir
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Turkey
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Malatya
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Turkey
State/province [144] 0 0
Mersin
Country [145] 0 0
Ukraine
State/province [145] 0 0
Dnipropetrovska Oblast
Country [146] 0 0
Ukraine
State/province [146] 0 0
Kharkivska Oblast
Country [147] 0 0
Ukraine
State/province [147] 0 0
Odeska Oblast
Country [148] 0 0
Ukraine
State/province [148] 0 0
Volynska Oblast
Country [149] 0 0
Ukraine
State/province [149] 0 0
Zakarpatska Oblast

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Eli Lilly and Company
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
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)
Address 0 0
Eli Lilly and Company
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
Address 0 0
Country 0 0
Phone 0 0
1-317-615-4559
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
When will data be available (start and end dates)?
Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.
Available to whom?
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://vivli.org/


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04975308