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Trial details
Study of Efficacy and Safety of LEE011 in Men and Postmenopausal Women With Advanced Breast Cancer ( MONALEESA 3)
Current status:
Approved
|
Date registered:
06/07/2020
Trial version(s)
History: 06/05/2019
History: 06/05/2019
History: 06/05/2019
History: 06/05/2019
History: 06/05/2019
History: 06/05/2019
History: 06/05/2019
History: 06/05/2019
History: 06/05/2019
History: 06/05/2019
History: 06/05/2019
History: 06/05/2019
History: 06/05/2019
History: 06/05/2019
History: 06/05/2019
History: 06/05/2019
Current: 06/05/2019
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Main Information
Primary registry identifying number
LBCTR2019080232
Protocol number
CLEE011F2301
MOH registration number
6427/ص
Trial already registered with the MoPH
Study registered at the country of origin
Type of registration
Retrospective
Type of registration: Justify
LCTR was recently initiated, original file was previously submitted by Paper
Date of registration in national regulatory agency
15/07/2015
Primary sponsor
Novartis Pharma Services Inc.
Primary sponsor: Country of origin
Novartis Pharmaceuticals
Public title
Study of Efficacy and Safety of LEE011 in Men and Postmenopausal Women With Advanced Breast Cancer ( MONALEESA 3)
Acronym
Scientific title
A Randomized Double-blind, Placebo-controlled Study of Ribociclib in Combination With Fulvestrant for the Treatment of Men and Postmenopausal Women With Hormone Receptor Positive, HER2-negative, Advanced Breast Cancer Who Have Received no or Only One Line of Prior Endocrine Treatment
Acronym
Brief summary of the study: English
This is a multi-center, randomized double-blind, placebo controlled study of ribociclib in combination with fulvestrant for the treatment of postmenopausal women and men with hormone receptor positiv e, Her2 negative, advanced breast cancer who have received no or only one line of endocrine therapy for advanced breast cancer.
Brief summary of the study: Arabic
دراسة عشوائية مزدوجة التعمية ومرتكزة على المقارنة بدواء وهمي حول دواء ريبوسيكليب بالتزامن مع فولفيسترانت لعلاج الرجال والنساء بعد انقطاع الطمث المصابين بسرطان الثدي المتقدّم الإيجابيّ مستقبلات الهرمون وسلبيّ الهير 2 الذين لم يتلقوا أي علاج سابق للغدد الصمّاء أو تلقّوا نوعاً واحداً منه فقط
Health conditions/problem studied: Specify
advanced breast cancer
Interventions: Specify
•Drug: Ribociclib Riblociclib 600mg daily oral (days 1 to 21 in a 28-day Cycle) Other Name: LEE011 •Drug: fulvestrant Fulvestrant 500mg i.m. injections every 28 days (Cycle n Day 1) with 1 additional dose on Day 15 of Cycle 1 Other Name: Faslodex •Drug: Ribociclib placebo Riblociclib placebo 600mg daily oral (days 1 to 21 in a 28-day Cycle) Other Name: LEE011 placebo
Key inclusion and exclusion criteria: Inclusion criteria
Inclusion Criteria: 1.Patient is an adult male/female ≥ 18 years old at the time of informed consent and has signed informed consent before any trial related activities and according to local guidelines. Female patients must be postmenopausal. 2.Patient has a histologically and/or cytologically confirmed diagnosis of estrogen-receptor positive and/or progesterone receptor positive breast cancer by local laboratory and has HER2-negative breast cancer. 3.Patient must have either measurable disease by RECIST 1.1 or at least one predominantly lytic bone lesion. 4.Patient has advanced (loco regionally recurrent not amenable to curative therapy, e.g. surgery and/or radiotherapy, or metastatic) breast cancer. Patients may be: ◦newly diagnosed advanced/metastatic breast cancer, treatment naïve ◦relapsed with documented evidence of relapse more than 12 months from completion of (neo)adjuvant endocrine therapy with no treatment for advanced/metastatic disease ◦relapsed with documented evidence of relapse on or within 12 months from completion of (neo)adjuvant endocrine therapy with no treatment for advanced/metastatic disease ◦relapsed with documented evidence of relapse more than 12 months from completion of adjuvant endocrine therapy and then subsequently progressed with documented evidence of progression after one line of endocrine therapy (with either an antiestrogen or an aromatase inhibitor) for advanced/metastatic disease ◦newly diagnosed advanced/metastatic breast cancer at diagnosis that progressed with documented evidence of progression after one line of endocrine therapy (with either an antiestrogen or an aromatase inhibitor) 5.Patient has an Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 6.Patient has adequate bone marrow and organ function
Key inclusion and exclusion criteria: Gender
Both
Key inclusion and exclusion criteria: Age minimum
18
Key inclusion and exclusion criteria: Age maximum
99
Key inclusion and exclusion criteria: Exclusion criteria
Exclusion Criteria: 1.Patient with symptomatic visceral disease or any disease burden that makes the patient ineligible for endocrine therapy per the investigator's best judgment. 2.Patient has received prior treatment with chemotherapy (except for neoadjuvant/ adjuvant chemotherapy), fulvestrant or any CDK4/6 inhibitor. 3.Patient with inflammatory breast cancer at screening . 4.Patient with CNS involvement unless they are at least 4 weeks from prior therapy completion to starting the study treatment and have stable CNS tumor at the time of screening and not receiving steroids and/or enzyme inducing anti-epileptic medications for brain metastases 5.Clinically significant, uncontrolled heart disease and/or cardiac repolarization abnormality 6.Patient is currently receiving any of the following substances and cannot be discontinued 7 days prior to start the treatment: ◦Known strong inducers or inhibitors of CYP3A4/5, ◦That have a known risk to prolong the QT interval or induce Torsades de Pointes. ◦Those have a narrow therapeutic window and are predominantly metabolized through CYP3A4/5. ◦Herbal preparations/medications, dietary supplements.
Type of Study
Type
Interventional
Type of intervention
Pharmaceutical
Trial scope
Therapy
Trial scope: Specify scope
Study design: Allocation
Randomized controlled trial
Study design: Masking
Blinded (masking used)
Study design: Control
Placebo
Study phase
3
Study design: Purpose
Treatment
Study design: Assignment
Parallel
IMP has market authorization
Yes, Lebanon and Worldwide
IMP has market authorization: Specify the countries
Worldwide ; Lebanon MOH approval: Postmenopausal
Name of IMP
Ribociclib ( Kisqali)
Year of authorization
2017
Month of authorization
8
Type of IMP
Others
Type of IMP: Specify
Endocrine based therapy: CDK4/6 inhibitor
Pharmaceutical class
Orally bioavailable, highly selective small molecule inhibitor of cyclin-dependent kinases 4 and 6 (CDK4/6).
Therapeutic indication
Men and Pre/Postmenopausal Women With Hormone Receptor-positive (HR+) HER2-negative (HER2-) Advanced Breast Cancer
Therapeutic benefit
increase OS & PFS
Biospecimen retention
Samples with DNA**
Biospecimen description
Q2 lab is the lab used in this study, ambiant lab samples shipped to central lab, Blood and urine samples . Samples for circulating tumor DNA (ctDNA) is also required
Target sample size
6
Actual enrollment target size
6
Date of first enrollment: Type
Actual
Date of first enrollment: Date
22/12/2015
Date of study closure: Type
Actual
Date of study closure: Date
23/02/2021
Recruitment status
Complete
Date of completion
06/05/2016
IPD sharing statement plan
No
IPD sharing statement description
Undecided ; Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent expert panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data is currently available according to the process described on www.clinicalstudydatarequest.com.
Additional data URL
https://clinicaltrials.gov/ct2/show/record/NCT02422615?term=breast+cancer+lebanon&draw=10
Summary Results
Secondary Identifying Numbers
Full name of issuing authority
Secondary identifying number
Clinicaltrials.gov
NCT02422615
Sources of Monetary or Material Support
Name
Novartis Pharma Services Inc.
Secondary Sponsors
Name
NA
Contact for Public/Scientific Queries
Contact type
First name
Last name
Address
Country
Telephone
Email
Affiliation
Public
Nagi
El Saghir
Beirut
Lebanon
961 1 350000 ext 7489
ns23@aub.edu.lb
American University of Beirut Medical Center
Scientific
Hind
Khairallah
Sin El Fil
Lebanon
+961 1 512002 Ext. 271
Hind.Khairallah@fattal.com.lb
Khalil Fattal et Fils s.a.l.
Public
Marwan
Ghosn
Beirut
Lebanon
00961 1 613395
marwanghosnmd@yahoo.com
Hotel Dieu De France
Centers/Hospitals Involved in the Study
Center/Hospital name
Name of principles investigator
Principles investigator speciality
Ethical approval
Hotel Dieu De France
Marwan Ghosn
Hematology Oncology
Approved
American University of Beirut Medical Center
Nagi El Saghir
Hematology Oncology
Approved
Ethics Review
Ethics approval obtained
Approval date
Contact name
Contact email
Contact phone
American University of Beirut Medical Center
14/09/2015
Fuad Ziyadeh
fz05@aub.edu.lb
+961 (0) 1 350 000 ext:5445
Hotel Dieu de France
17/06/2015
Nancy Alam
nancy.alam@usj.edu.lb
+961 (0) 1 421000 ext 2335
Countries of Recruitment
Name
Lebanon
Argentina
Austria
Belgium
Bulgaria
Canada
Colombia
Czech Republic
France
Denmark
Germany
Hungary
Italy
Jordan
Mexico
Switzerland
United Kingdom
United States of America
Health Conditions or Problems Studied
Condition
Code
Keyword
Advanced Breast Cancer
Breast, unspecified (C50.9)
Advanced Breast Cancer
Interventions
Intervention
Description
Keyword
ICF, medical history, demography, radiology, vital signs, IMP administration
ICF, medical history, demography, radiology, vital signs, IMP administration
ICF, Lab, IMP, radiology
Primary Outcomes
Name
Time points
Measure
Progression Free Survival (PFS) Per Investigator Assessment
26 months
26 months
Key Secondary Outcomes
Name
Time points
Measure
Overall Survival (OS)
58 months
58 months
•Progression Free Survival (PFS) Per Blinded Independant Review Committee (BICR)
26 months
26 months
•Overall Response Rate (ORR)
26 months
26 months
•Safety and Tolerability of LEE011
26 months
26 months
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
IL submission, bi-annual SUSARs and AUBMC protocol amendment 3 approval
05/06/2020
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