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Trial details
Trial details
Study of Efficacy and Safety of LEE011 in Postmenopausal Women With Advanced Breast Cancer.(MONALEESA-2)
Current status:
Approved
|
Date registered:
15/12/2020
Trial version(s)
History: 03/05/2019
History: 03/05/2019
History: 03/05/2019
History: 03/05/2019
History: 03/05/2019
History: 03/05/2019
History: 03/05/2019
History: 03/05/2019
History: 03/05/2019
History: 03/05/2019
History: 03/05/2019
History: 03/05/2019
History: 03/05/2019
History: 03/05/2019
History: 03/05/2019
History: 03/05/2019
History: 03/05/2019
History: 03/05/2019
History: 03/05/2019
Current: 03/05/2019
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Main Information
Primary registry identifying number
LBCTR2019050229
Protocol number
CLEE011A2301
MOH registration number
9695/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
05/11/2014
Primary sponsor
Novartis Pharma Services Inc.
Primary sponsor: Country of origin
Novartis Pharmaceuticals
Public title
Study of Efficacy and Safety of LEE011 in Postmenopausal Women With Advanced Breast Cancer.(MONALEESA-2)
Acronym
Scientific title
A Randomized Double-blind, Placebo-controlled Study of LEE011 in Combination With Letrozole for the Treatment of Postmenopausal Women With Hormone Receptor Positive, HER2 Negative, Advanced Breast Cancer Who Received no Prior Therapy for Advanced Disease
Acronym
Brief summary of the study: English
This is a multi-center, randomized, double-blinded, placebo controlled trial. , The primary purpose of this study was to assess the efficacy of LEE011, as measured by progression free survival (PFS), in postmenopausal women with HR positive, HER2 negative advanced breast cancer who received no prior treatment for advanced disease.
Brief summary of the study: Arabic
ددراسة عشوائية مزدوجة التعمية ومضبّطة بدواء وهميّ حول سلامة استخدام الدواء LEE011 مع ليتروزول Letrozole وفعاليته في معالجة النساء بعد انقطاع الطمث المصابات بسرطان ثدي متقدّم إيجابيّ مستقبلات الهرمون وسلبيّ الهير 2 واللواتي لم يتلقّين علاجاً سابقاً للمرض في مراحله المتقدّمة
Health conditions/problem studied: Specify
Advanced Breast Cancer
Interventions: Specify
•Drug: LEE011 Ribociclib was administered orally at a dose of 600 mg once daily (three 200 mg capsules). •Drug: Letrozole Letrozole 2.5 mg tablets taken orally. •Drug: LEE011 Placebo Matching ribociclib placebo was the control drug and was administered orally once daily.
Key inclusion and exclusion criteria: Inclusion criteria
1.Women with advanced (locoregionally recurrent or metastatic) breast cancer not amenable to curative therapy. 2.Patient is postmenopausal. Postmenopausal status is defined either by: ◦Prior bilateral oophorectomy ◦Age ≥60 ◦Age <60 and amenorrhea for 12 or more months (in the absence of chemotherapy, tamoxifen, toremifen, or ovarian suppression) and FSH and estradiol in the postmenopausal range per local normal range Note: For women with therapy-induced amenorrhea, serial measurements of FSH and/or estradiol are needed to ensure postmenopausal status. Ovarian radiation or treatment with a luteinizing hormone-releasing hormone agonist (LH-RHa) (goserelin acetate or leuprolide acetate) is not permitted for induction of ovarian suppression in this trial. 3.No prior systemic anti-cancer therapy for advanced disease. 4.Patient has a histologically and/or cytologically confirmed diagnosis of estrogen-receptor positive and/or progesterone receptor positive breast cancer by local laboratory. 5.Patient has HER2-negative breast cancer defined as a negative in situ hybridization test or an IHC status of 0, 1+ or 2+. If IHC is 2+, a negative in situ hybridization (FISH, CISH, or SISH) test is required by local laboratory testing. 6.Patient must have either: • Measurable disease, i.e., at least one measurable lesion as per RECIST 1.1 criteria (Tumor lesions previously irradiated or subjected to other locoregional therapy will only be considered measurable if disease progression at the treated site after completion of therapy is clearly documented). OR • If no measurable disease is present, then at least one predominantly lytic bone lesion must be present (Patients with no measurable disease and only one predominantly lytic bone lesion that has been previously irradiated are eligible if there is documented evidence of disease progression of the bone lesion after irradiation). 7.Patient has an Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
Key inclusion and exclusion criteria: Gender
Female
Key inclusion and exclusion criteria: Age minimum
18
Key inclusion and exclusion criteria: Age maximum
99
Key inclusion and exclusion criteria: Exclusion criteria
1.Patient who received any CDK4/6 inhibitor. 2.Patient who received any prior systemic anti-cancer therapy (including hormonal therapy and chemotherapy) for advanced breast cancer Note: ◦Patients who received (neo) adjuvant therapy for breast cancer are eligible. If the prior neo (adjuvant) therapy included letrozole or anastrozole the disease free interval must be greater than 12 months from the completion of treatment until randomization. ◦Patients who received ≤ 14 days of letrozole or anastrozole for advanced disease prior to randomization are eligible. ◦Any prior (neo) adjuvant anti-cancer therapy must be stopped at least 5 half-lives or 7 days, whichever is longer, before randomization 3.Patient is concurrently using other anti-cancer therapy. 4.Patient has a concurrent malignancy or malignancy within 3 years of randomization, with the exception of adequately treated, basal or squamous cell carcinoma, non-melanomatous skin cancer or curatively resected cervical cancer. 5.Patient has active cardiac disease or a history of cardiac dysfunction including any of the following: ◦History of angina pectoris, symptomatic pericarditis, or myocardial infarction within 12 months prior to study entry ◦History of documented congestive heart failure (New York Heart Association functional classification III-IV) ◦Documented cardiomyopathy ◦Patient has a Left Ventricular Ejection Fraction (LVEF) < 50% as determined by Multiple Gated acquisition (MUGA) scan or echocardiogram (ECHO) ◦History of any cardiac arrhythmias, e.g., ventricular, supraventricular, nodal arrhythmias, or conduction abnormality in the previous 12 months. ◦On screening, any of the following cardiac parameters: bradycardia (heart rate < 50 at rest), tachycardia (heart rate > 90 at rest), PR interval > 220 msec, QRS interval >109 msec, or QTcF >450 msec. •Systolic blood pressure >160 or <90 mmHg 6. Patient is currently receiving any of the following medications and cannot be discontinued 7 days prior start if the treatment: •That are known strong inducers or inhibitors of CYP3A4. •That have a known risk to prolong the QT interval or induce Torsades de Pointes. •That have a narrow therapeutic window and are predominantly metabolized through CYP3A4. •Herbal preparations/medications
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
Lebanon and Worldwide
Name of IMP
Ribociclib
Year of authorization
2017
Month of authorization
8
Type of IMP
Others
Type of IMP: Specify
CDK4/6 inhibitor
Pharmaceutical class
Orally bioavailable, highly selective small molecule inhibitor of cyclin-dependent kinases 4 and 6 (CDK4/6).
Therapeutic indication
postmenopausal women with hormone receptor positive, HER2-negative, advanced breast cancer who received no prior therapy for advanced disease.
Therapeutic benefit
increase OS & PFS
Biospecimen retention
Samples with DNA**
Biospecimen description
Samples with circulating tumor DNA will be done, in addition to safety Labs ( CBC, chemistry ) sent to central lab : Covance located in Switzerland.
Target sample size
15
Actual enrollment target size
15
Date of first enrollment: Type
Actual
Date of first enrollment: Date
29/04/2014
Date of study closure: Type
Actual
Date of study closure: Date
20/12/2021
Recruitment status
Complete
Date of completion
12/02/2015
IPD sharing statement plan
Yes
IPD sharing statement description
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. URL: http://www.clinicalstudydatarequest.com
Additional data URL
https://clinicaltrials.gov/ct2/show/record/NCT01958021?id=CLEE011A2301&rank=1
Summary Results
Secondary Identifying Numbers
Full name of issuing authority
Secondary identifying number
Clinicaltrials.gov
NCT01958021
Sources of Monetary or Material Support
Name
Novartis Pharma Services Inc.
Secondary Sponsors
Name
Contact for Public/Scientific Queries
Contact type
First name
Last name
Address
Country
Telephone
Email
Affiliation
Public
Joseph
Kattan
Beirut
Lebanon
9613635913
jkattan62@hotmail.com
Hotel Dieu De France
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
Fadi
Farhat
Saida
Lebanon
03-753155
drfadi.trials@gmail.com
Hammoud Hospital UniversityMedical Center
Public
Fadi
El Karak
Beirut
Lebanon
03-061621
felkarak@yahoo.com
Bellevue Medical Center
Public
Ziad
Salem
Beirut
Lebanon
9611347263
zs04@aub.edu.lb
American University of Beirut Medical Center
Centers/Hospitals Involved in the Study
Center/Hospital name
Name of principles investigator
Principles investigator speciality
Ethical approval
Hotel Dieu De France
Dr Joseph Kattan
Hematology Oncology
Approved
Hammoud Hospital University Medical Center
Dr Fadi Farhat
Hematology Oncology
Approved
Bellevue Medical Center
Dr Fadi El Karak
Hematology Oncology
Approved
American University of Beirut Medical Center
Dr Ziad Salem
Hematology Oncology
Approved
Ethics Review
Ethics approval obtained
Approval date
Contact name
Contact email
Contact phone
American University of Beirut Medical Center
05/09/2014
Fuad Ziyadeh
fz05@aub.edu.lb
+961 (0) 1 350 000 ext:5445
Hotel Dieu de France
20/09/2013
Nancy Alam
nancy.alam@usj.edu.lb
+961 (0) 1 421000 ext 2335
Bellevue Medical Center
20/02/2014
Ghassan Maalouf
gmaalouf@bmc.com.lb
+961 (0) 1 682666 ext 7600
Hammoud Hospital University Medical Center
30/10/2013
Ahmad Zaatari
zaatari@hammoudhospital.com
+961 (0) 7 723111 ext 1160
Countries of Recruitment
Name
Lebanon
Argentina
Australia
Austria
Belgium
Brazil
Canada
Denmark
Finland
France
Germany
Hungary
Ireland
Italy
Netherlands
Norway
Singapore
Spain
Sweden
Turkey
United Kingdom
United States of America
Health Conditions or Problems Studied
Condition
Code
Keyword
Advanced Breast Cancer
Malignant neoplasm of breast (C50)
ABC
Interventions
Intervention
Description
Keyword
Physical Exam, Vital signs, ECG, Echocardiography, Urinalysis, Serum/ urine pregnancy test, lab test, completion of QoL questionnaires
Physical Exam, Vital signs, ECG, Echocardiography, Urinalysis, Serum/ urine pregnancy test, lab test, completion of QoL questionnaires
ICF, Lab, IMP, radiology
Primary Outcomes
Name
Time points
Measure
Progression Free Survival
20 months
PFS up to approximately 20 months
Key Secondary Outcomes
Name
Time points
Measure
•Overall Response Rate (ORR)
20 months
20 months
Overall survival
65 months
65 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
Protocol 8 and 9 IRB letter -Bellevue
13/12/2020
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