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Trial details
Trial details
A phase III randomized double-blind, placebo controlled study of alpelisib in combination with fulvestrant for men and postmenopausal women with hormone receptor positive, HER2-negative advanced breast cancer which progressed on or after aromatase inhibitor treatment
Current status:
Approved
|
Date registered:
17/02/2020
Trial version(s)
History: 07/02/2019
History: 07/02/2019
History: 07/02/2019
History: 07/02/2019
History: 07/02/2019
History: 07/02/2019
History: 07/02/2019
History: 07/02/2019
History: 07/02/2019
History: 07/02/2019
History: 07/02/2019
History: 07/02/2019
History: 07/02/2019
History: 07/02/2019
History: 07/02/2019
History: 07/02/2019
Current: 07/02/2019
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Main Information
Primary registry identifying number
LBCTR2019030190
Protocol number
CBYL719C2301
MOH registration number
7829/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
27/08/2015
Primary sponsor
Novartis Pharma Services Inc.
Primary sponsor: Country of origin
Novartis Pharmaceuticals
Public title
A phase III randomized double-blind, placebo controlled study of alpelisib in combination with fulvestrant for men and postmenopausal women with hormone receptor positive, HER2-negative advanced breast cancer which progressed on or after aromatase inhibitor treatment
Acronym
SOLAR-1
Scientific title
SOLAR-1: A phase III randomized double-blind, placebo controlled study of alpelisib in combination with fulvestrant for men and postmenopausal women with hormone receptor positive, HER2-negative advanced breast cancer which progressed on or after aromatase inhibitor treatment
Acronym
Brief summary of the study: English
To determine whether treatment with alpelisib plus fulvestrant prolongs progression-free survival compared to fulvestrant and placebo in men and postmenopausal women with hormone receptor positive (HR+), HER2-negative advanced breast cancer, who received prior treatment with an Aromatase Inhibitor either as (neo)adjuvant or for advanced disease
Brief summary of the study: Arabic
سولار – 1: دراسة عشوائيّة التوزيع، مزدوجة التعمية، مضبطة الدواء الوهمي في المرحلة الثالثة حول ألبيليسيب بالاشتراك مع فولفسترانت للرجال والنساء ما بعد انقطاع الطمث المصابين بسرطان الثدي المتقدّم مع مستقبِل هورمون إيجابي- HER2 – سلبي الذي تطوّر عند أو بعد علاج بمثبّط للأروماتاز
Health conditions/problem studied: Specify
men and postmenopausal women with hormone receptor positive, HER2-negative advanced breast cancer which progressed on or after aromatase inhibitor treatment
Interventions: Specify
IMP : BYL719 Alpelisib
Key inclusion and exclusion criteria: Inclusion criteria
Inclusion Criteria: •If female, patient is postmenopausal •Patient has identified PIK3CA status •Patients may be: ◦relapsed with documented evidence of progression while on (neo) adjuvant endocrine therapy or within 12 months from completion of (neo)adjuvant endocrine therapy with no treatment for metastatic disease; ◦relapsed with documented evidence of progression more than 12 months from completion of (neo)adjuvant endocrine therapy and then subsequently; progressed with documented evidence of progression while on or after only one line of endocrine therapy for metastatic disease; ◦newly diagnosed advanced breast cancer, then relapsed with documented evidence of progression while on or after only one line of endocrine therapy •Patient has recurrence or progression of disease during or after AI therapy (i.e. letrozole, anastrozole, exemestane). •Patient has a histologically and/or cytologically confirmed diagnosis of estrogen-receptor positive breast cancer by local laboratory and has HER2 negative breast cancer •Patient has either measurable disease per RECIST 1.1 criteria OR at least one predominantly lytic bone lesion must be present •Patient has adequate bone marrow 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: •Patient with symptomatic visceral disease or any disease burden that makes the patient ineligible for endocrine therapy per the investigator's best judgment •Patient has received prior treatment with chemotherapy (except for neoadjuvant/ adjuvant chemotherapy), fulvestrant, any PI3K, mTOR or AKT inhibitor (pre-treatment with CDK4/6 inhibitors is allowed) •Patient with inflammatory breast cancer at screening •Patients with Child pugh score B or C •Patients with an established diagnosis of diabetes mellitus type I or not controlled type II •Patient has Eastern Cooperative Oncology Group (ECOG) performance status 2 or more •Patient with CNS involvement unless he/she is at least 4 weeks from prior therapy completion to starting the study treatment and has stable CNS tumor at time of screening and not receiving steroids and/or enzyme inducing ant-epileptic medications for brain metastases •Patient has participated in a prior investigational study within 30 days prior to enrollment or within 5 half-lives of the investigational product, whichever is longer •Patient has a history of acute pancreatitis within 1 year of screening or a past medical history of chronic pancreatitis •Patient who relapsed with documented evidence of progression more than 12 months from completion of (neo)adjuvant endocrine therapy with no treatment for metastatic disease Other protocol-defined inclusion/esclusion criteria may apply
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
No
Name of IMP
BYL719 ( ALpelisib)
Type of IMP
Others
Type of IMP: Specify
PI3K Inhibitor
Pharmaceutical class
α-specific class I phosphatidylinositol-3-kinase (PI3K) inhibitor belonging to the 2-aminothiazole class of compounds.
Therapeutic indication
hormone receptor positive, HER2-negative advanced breast cancer which progressed on or after aromatase inhibitor treatment
Therapeutic benefit
Progression-free survival (PFS) [ Time Frame: Up to approximatly 36 months ] Overall survival (OS) for patients with PI3KCA mutant status [ Time Frame: Up to approximatly 59 months ] Overall response rate (ORR) [ Time Frame: Up to approximatly 36 months ] Time to definitive deterioration of Eastern Cooperative Oncology Group (ECOG) performance status [ Time Frame: Baseline, Up to approximatly 36 months ]
Biospecimen retention
Samples without DNA
Biospecimen description
Blood, urine and Tissue samples shipped to Quintiles central Lab or Genoptix BioPharma Lab in the UK ; Laboratory (Hematology, chemistry, biomarkers, pharmacokinetics), Urinalysis shipped to Quintiles (Q2) central Lab in the UK and Tissue Slides sent to Genoptix Central Lab in the UK
Target sample size
8
Actual enrollment target size
8
Date of first enrollment: Type
Actual
Date of first enrollment: Date
16/02/2016
Date of study closure: Type
Actual
Date of study closure: Date
28/04/2022
Recruitment status
Complete
Date of completion
09/06/2017
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 review 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 availability is according to the criteria and process described on www.clinicalstudydatarequest.com
Additional data URL
https://clinicaltrials.gov/ct2/show/NCT02437318?term=CBYL719C2301&rank=1
Summary Results
Secondary Identifying Numbers
Full name of issuing authority
Secondary identifying number
National Institute of Health (clinicaltrials.gov)
NCT02437318
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
Joseph
Kattan
Beirut
Lebanon
009613635913
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
El Karak
Mansourieh
Lebanon
+961 3 061 621
felkarak@yahoo.com
Bellevue Medical Center
Public
Fadi
Farhat
Saida
Lebanon
+9613753155
drfadi.trials@gmail.com
Hammoud Hospital
Centers/Hospitals Involved in the Study
Center/Hospital name
Name of principles investigator
Principles investigator speciality
Ethical approval
Hammoud Hospital University Medical Center
Dr Fadi Farhat
Hematology Oncology
Approved
Bellevue Medical Center
Dr Fadi El Karak
Hematology Oncology
Approved
Hotel Dieu De France
Dr Joseph Kattan
Hematology Oncology
Approved
Ethics Review
Ethics approval obtained
Approval date
Contact name
Contact email
Contact phone
Hotel Dieu de France
01/06/2015
Nancy Alam
nancy.alam@usj.edu.lb
+961 (0) 1 421000 ext 2335
Bellevue Medical Center
04/09/2015
Ghassan Maalouf
gmaalouf@bmc.com.lb
+961 (0) 1 682666 ext 7600
Hammoud Hospital University Medical Center
05/08/2015
Ahmad Zaatari
zaatari@hammoudhospital.com
+961 (0) 7 723111 ext 1160
Countries of Recruitment
Name
Argentina
Australia
Austria
Belgium
Brazil
Bulgaria
Canada
Chile
Lebanon
China
Germany
Italy
France
India
Health Conditions or Problems Studied
Condition
Code
Keyword
Advanced Breast Cancer
Breast, unspecified (C50.9)
ABC
Interventions
Intervention
Description
Keyword
Laboratory (Hematology, chemistry, biomarkers, pharmacokinetics), Urinalysis, ECG, Echocardio, Physical Exma, Vital Signs
Lab, ICF, ECG, IMP administration
ICF, Lab, ECG, IMP
Primary Outcomes
Name
Time points
Measure
Progression-free survival (PFS) for patients with PIK3CA mutant status
Up to approximatly 36 months
36 Months
Key Secondary Outcomes
Name
Time points
Measure
Overall survival (OS) for patients with PI3KCA mutant status
59 months
59 months
Overall response rate (ORR)
36 months
36 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
Import license submission and notification regarding Mg issue
11/02/2020
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