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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04752332




Registration number
NCT04752332
Ethics application status
Date submitted
11/02/2021
Date registered
12/02/2021

Titles & IDs
Public title
A Study of Abemaciclib (LY2835219) Plus Hormone Therapy in Participants With Early Breast Cancer
Scientific title
eMonarcHER: A Randomized, Double Blind, Placebo-Controlled Phase 3 Study of Abemaciclib Plus Standard Adjuvant Endocrine Therapy in Participants With High-Risk, Node-Positive, HR+, HER2+ Early Breast Cancer Who Have Completed Adjuvant HER2-Targeted Therapy
Secondary ID [1] 0 0
I3Y-MC-JPCW
Secondary ID [2] 0 0
17384
Universal Trial Number (UTN)
Trial acronym
eMonarcHER
Linked study record

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

Intervention/exposure
Study type
Interventional(has expanded access)
Description of intervention(s) / exposure
Treatment: Drugs - Abemaciclib
Treatment: Drugs - Standard Adjuvant ET
Treatment: Drugs - Placebo

Experimental: Abemaciclib Plus (+) Endocrine Therapy (ET) - Abemaciclib administered orally and standard adjuvant ET (physician's choice) administered according to package label.

Active comparator: Placebo + ET - Placebo administered orally and standard adjuvant ET (physician's choice) administered according to package label.


Treatment: Drugs: Abemaciclib
Administered orally.

Treatment: Drugs: Standard Adjuvant ET
Administered according to label instructions.

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

Outcomes
Primary outcome [1] 0 0
Invasive Disease Free Survival (IDFS)
Timepoint [1] 0 0
Randomization to Recurrence or Death from Any Cause (up to 10 Years)
Secondary outcome [1] 0 0
Overall Survival (OS)
Timepoint [1] 0 0
Randomization to Death from Any Cause (up to 10 Years)
Secondary outcome [2] 0 0
Distant Relapse-Free Survival (DRFS)
Timepoint [2] 0 0
Randomization to Distant Recurrence or Death from Any Cause (up to 10 Years)
Secondary outcome [3] 0 0
Percentage of Participants with Central Nervous System (CNS) Metastases as First Site of Disease Recurrence
Timepoint [3] 0 0
Randomization to Distant Recurrence or Death from Any Cause (up to 10 Years)
Secondary outcome [4] 0 0
Change from Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Scale Score
Timepoint [4] 0 0
Cycle 1 up to end of Year 4
Secondary outcome [5] 0 0
Change from Baseline in the EuroQOL 5 Dimension 5 Level (EQ-5D 5L) Index Score
Timepoint [5] 0 0
Cycle 1 up to end of Year 4
Secondary outcome [6] 0 0
Pharmacokinetics (PK): Mean Steady State Concentrations of Abemaciclib
Timepoint [6] 0 0
Day 1 of Cycles 1-3 (Cycle = 28 days)

Eligibility
Key inclusion criteria
* Have confirmed HR+, HER2+ early invasive breast cancer without evidence of disease recurrence or distant metastases
* Have undergone definitive surgery of the primary breast tumor(s)
* Have tumor tissue from breast (preferred) or lymph node
* Have received a minimum of four cycles of chemotherapy in either the neoadjuvant or adjuvant setting per standard of care
* Have completed approximately nine to 20 months of standard HER2-targeted therapy (neoadjuvant/adjuvant combined duration)
* Have received one of the following eligible HER2-targeted adjuvant regimens AND be randomized within 12 weeks of completing the regimen:

* For participants treated with neoadjuvant therapy and HER2-targeted therapy: A minimum of 4 cycles of T-DM1 in the adjuvant setting. NOTE: Participants may have received up to approximately 6 cycles of adjuvant trastuzumab prior to initiation of T-DM1. Additionally, participants may have switched to trastuzumab-based therapy (monotherapy or in combination with other HER2-targeted therapies) after 4 cycles of T-DM1
* For participants who had definitive surgery prior to systemic therapy, a minimum of 4 cycles of adjuvant pertuzumab with trastuzumab.
* Have high risk disease, defined by one of the following criteria:

* Those who received neoadjuvant chemotherapy along with HER2-targeted treatment must have:

* residual disease in at least one axillary lymph node, or
* a residual tumor = 5 cm, or
* a residual tumor of any size that has direct extension to the chest wall and/or skin (ulceration or skin nodules).
* Those who had definitive surgery prior to systemic therapy and completed adjuvant chemotherapy along with HER2-targeted therapies (trastuzumab and pertuzumab) must have

* tumor involvement in =4 ipsilateral axillary lymph nodes, or
* tumor involvement in 1 to 3 ipsilateral axillary lymph node(s) and histological Grade 3, or
* primary invasive tumor size of = 5 cm on pathological evaluation.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Have breast cancer with any of the following features:

* Disease recurrence or distant metastatic disease (including contralateral axillary lymph nodes)
* Pathological complete response from any prior early breast cancer treatments. Participants are required to have residual primary tumor and/or lymph node disease at the time of definitive surgery as indicated in inclusion criteria.
* Inflammatory breast cancer
* Have other medical conditions including:

* Previous breast cancer (Exceptions: Ipsilateral ductal carcinoma in situ [DCIS] treated by locoregional therapy alone =5 years ago; contralateral DCIS treated by locoregional therapy at any time)
* Other cancer being treated and/or not in complete remission within the last 5 years (Exceptions: Appropriately treated non-melanomatous skin cancer or carcinoma in situ of cervix, bladder, or colon)
* Females who are pregnant or lactating
* History of venous thromboembolism
* Other serious medical conditions
* Have previously received treatment with:

* Any cyclin-dependent kinase (CDK)4 and CDK6 inhibitor
* Prior adjuvant treatment with immunotherapy, tucatinib, neratinib, any investigational HER2 directed therapy, or T-DXd (DS8201) for treatment of breast cancer
* Endocrine therapy (ET) (i.e., tamoxifen, raloxifene or aromatase inhibitor) for breast cancer prevention (without diagnosis of breast cancer)
* Additional chemotherapy, anti-cancer ET, or HER2-targeted therapy beyond standard of care at study enrollment

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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
10/05/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
26/06/2024
Sample size
Target
Accrual to date
Final
111
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Calvary Mater Newcastle - Waratah
Recruitment hospital [2] 0 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment postcode(s) [1] 0 0
2298 - Waratah
Recruitment postcode(s) [2] 0 0
3000 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
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United States of America
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California
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Florida
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United States of America
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Illinois
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Missouri
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United States of America
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New Jersey
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United States of America
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Tennessee
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United States of America
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Texas
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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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Tucumán
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Argentina
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La Rioja
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Argentina
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Salta
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Argentina
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San Juan
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Austria
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Oberösterreich
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Austria
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Wien
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Belgium
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Oost-Vlaanderen
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Belgium
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Wallonne, Région
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Belgium
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West-Vlaanderen
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Brazil
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Rio de Janeiro
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Brazil
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São Paulo
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China
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Anhui
Country [24] 0 0
China
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Beijing
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China
State/province [25] 0 0
Fujian
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China
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Guangdong
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China
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Hainan
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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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Shandong
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China
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Shanghai
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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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Xinjiang
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China
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Zhejiang
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France
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Doubs
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France
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Meurthe-et-Moselle
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France
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Nord
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France
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Pays-de-la-Loire
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Germany
State/province [43] 0 0
Baden-Württemberg
Country [44] 0 0
Germany
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Nordrhein-Westfalen
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Greece
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Attikí
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Greece
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Thessaloníki
Country [47] 0 0
Greece
State/province [47] 0 0
Thessaloniki
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Hungary
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Gyor-Moson-Sopron
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Israel
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Tell Abib
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Italy
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Taranto
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Italy
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Verona
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Italy
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Macerata
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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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Gunma
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Ibaraki
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Ishikawa
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Japan
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Kanagawa
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Japan
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Tokyo
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Japan
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Fukuoka
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Japan
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Hiroshima
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Japan
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Kagoshima
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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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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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Seoul-teukbyeolsi [Seoul]
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Mexico
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Distrito Federal
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Mexico
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Jalisco
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Spain
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A Coruña [La Coruña]
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Spain
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Madrid, Comunidad De
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Spain
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Málaga
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Spain
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Santa Cruz De Tenerife
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Spain
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Madrid
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Spain
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Valencia
Country [78] 0 0
Switzerland
State/province [78] 0 0
Sankt Gallen
Country [79] 0 0
Switzerland
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Zürich
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Taiwan
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Taipei
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Taiwan
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Taoyuan
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United Kingdom
State/province [82] 0 0
Bristol, City Of
Country [83] 0 0
United Kingdom
State/province [83] 0 0
Essex
Country [84] 0 0
United Kingdom
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Hammersmith And Fulham
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United Kingdom
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London
Country [86] 0 0
United Kingdom
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Suffolk
Country [87] 0 0
United Kingdom
State/province [87] 0 0
Sutton
Country [88] 0 0
United Kingdom
State/province [88] 0 0
Manchester

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
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
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 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/NCT04752332