Toggle navigation
Lebanon Clinical Trials Registry
Home
About Us
FAQs
Contact Us
Search Trials
Register
Log in
User Guide
Trial details
You are here
Home
Search Trials
Trial details
Trial details
Real-World Evidence Study on AbeMaciclib Treatment Patterns and Effectiveness in Patients with HR+/HER2- Locally Advanced or Metastatic BReAst CancEr in Kuwait and Lebanon.
Current status:
Approved
|
Date registered:
09/12/2022
Trial version(s)
Current: 16/03/2022
Click here to view the tips and fields' descriptions
Main Information
Primary registry identifying number
LBCTR2022035014
Protocol number
TRACE 2020-9591
MOH registration number
Trial already registered with the MoPH
Study registered at the country of origin
Type of registration
Prospective
Date of registration in national regulatory agency
Primary sponsor
Eli Lilly
Primary sponsor: Country of origin
United Arab Emirates
Public title
Real-World Evidence Study on AbeMaciclib Treatment Patterns and Effectiveness in Patients with HR+/HER2- Locally Advanced or Metastatic BReAst CancEr in Kuwait and Lebanon.
Acronym
Scientific title
Real-World Evidence Study on AbeMaciclib Treatment Patterns and Effectiveness in Patients with HR+/HER2- Locally Advanced or Metastatic BReAst CancEr in Kuwait and Lebanon.
Acronym
Brief summary of the study: English
The current observational study aims to obtain real-world data about the treatment patterns of patients with HR+/HER2- receiving Abemaciclib in locally advanced or metastatic breast cancer in Kuwait and Lebanon. The study also aims to obtain real-world data on the clinical characteristics, the response rate, and the progression-free survival of the locally advanced or metastatic breast cancer patients receiving Abemaciclib.
Brief summary of the study: Arabic
تهدف الدراسة القائمة على الملاحظة الحالية إلى الحصول على بيانات من العالم الحقيقي حول أنماط العلاج للمرضى HR + / HER2- تلقي Abemaciclib في سرطان الثدي المتقدم محليًا أو النقيلي في الكويت ولبنان. تهدف الدراسة أيضًا إلى الحصول على بيانات واقعية حول الخصائص السريرية ومعدل الاستجابة و البقاء على قيد الحياة دون تقدم لمرضى سرطان الثدي المتقدمين محليًا أو النقيلي الذين يتلقون العلاج
Health conditions/problem studied: Specify
locally advanced or metastatic breast cancer
Interventions: Specify
Abemaciclib (VERZENIO™)
Key inclusion and exclusion criteria: Inclusion criteria
Inclusion criteria Patients eligible for inclusion in this study have to fulfill all of the following criteria: 1. Adult breast cancer female patients ≥18 years old at the start of receiving Abemaciclib, whether as a single-agent treatment or combination treatment 2. Premenopausal or postmenopausal patients with histologically proven HR-positive, HER2-negative with locally advanced or metastatic breast cancer (De-novo or recurrence/progression of early breast cancer) 3. Patients who are being treated or have been treated with Abemaciclib (VERZENIO™), whether as a single-agent treatment or combination treatment, for at least three months before data collection 4. Patients treated with Abemaciclib (VERZENIO™), whether as a single-agent treatment or combination treatment, according to the SmPC.
Key inclusion and exclusion criteria: Gender
Female
Key inclusion and exclusion criteria: Age minimum
18
Key inclusion and exclusion criteria: Age maximum
90
Key inclusion and exclusion criteria: Exclusion criteria
Exclusion criteria 1. Patients previously included in Abemaciclib clinical trial 2. Patients with evidence of other prior second primary concurrent malignancy apart from locally advanced or metastatic breast cancer.
Type of Study
Type
Observational
Study model
Case-Control
Study model: Explain model
This is an observational, retrospective, multicenter, single-arm cohort study based on the review of medical records of HR-positive/HER2-negative locally advanced or metastatic breast cancer patients receiving Abemaciclib
Time perspective
Retrospective
Time perspective: Explain time perspective
All study data will be collected retrospectively from the electronic or paper medical records and will cover the period from the date of HR-positive/HER2-negative locally advanced or metastatic breast cancer patients’ diagnosis until patients’ inclusion dates.
Target follow-up duration
3
Target follow-up duration: Unit
months
Number of groups/cohorts
1
Biospecimen retention
None retained
Biospecimen description
N/A
Target sample size
100
Actual enrollment target size
100
Date of first enrollment: Type
Actual
Date of first enrollment: Date
19/10/2021
Date of study closure: Type
Actual
Date of study closure: Date
25/04/2022
Recruitment status
Recruiting
Date of completion
IPD sharing statement plan
No
IPD sharing statement description
N/A
Additional data URL
Summary Results
Secondary Identifying Numbers
Full name of issuing authority
Secondary identifying number
Sources of Monetary or Material Support
Name
Eli Lilly, UAE
Secondary Sponsors
Name
CTI
Contact for Public/Scientific Queries
Contact type
First name
Last name
Address
Country
Telephone
Email
Affiliation
Public
Sarah
Kharsa
Beirut
Lebanon
+96181209199
s.kharsa@ctifacts.com
CRO
Scientific
Sarah
Kharsa
Beirut
Lebanon
+96181209199
s.kharsa@ctifacts.com
CRO
Centers/Hospitals Involved in the Study
Center/Hospital name
Name of principles investigator
Principles investigator speciality
Ethical approval
Hotel Dieu de France Hospital
Dr Joseph Kattan
Oncology
Approved
American University of Beirut Medical Center
Dr Nagi El Saghir
Oncology
Approved
Rizk Hospital (LAUMCRH)
Dr Hady Ghanem
Oncology
Approved
Ethics Review
Ethics approval obtained
Approval date
Contact name
Contact email
Contact phone
American University of Beirut Medical Center
15/09/2021
May Ammar
ma117@aub.edu.lb
+961 1 350000 ext: 2979
Hotel Dieu de France
26/07/2021
Nancy El Alam
nancy.alam@usj.edu.lb
+961 421 400
Lebanese American University- University Medical Center Rizk Hospital
02/12/2021
Karmen Baroudy
karmen.baroudy@lau.edu.lb
+961 9 547254 ext. 2546
Countries of Recruitment
Name
Lebanon
Kuwait
Health Conditions or Problems Studied
Condition
Code
Keyword
Breast Cancer
2-Propanol (T51.2)
Breast Cancer
Interventions
Intervention
Description
Keyword
Primary Outcomes
Name
Time points
Measure
Treatment patterns
3
N/A
Key Secondary Outcomes
Name
Time points
Measure
Progression free survival
3
N/A
Trial Results
Summary results in Lebanon
Study results globally
Date of posting of results summaries
Date of first journal publication of results
Results URL link
Baseline characteristics
Participant flow
Adverse events
Outcome measures
URL to protocol files
Link(s) to publications related to the study
Changes History
Change
Date
Download as PDF
Save a PDF copy of the summary of the trial