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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04478266




Registration number
NCT04478266
Ethics application status
Date submitted
10/07/2020
Date registered
20/07/2020

Titles & IDs
Public title
Amcenestrant (SAR439859) Plus Palbociclib as First Line Therapy for Patients With ER (+) HER2(-) Advanced Breast Cancer
Scientific title
A Randomized, Multicenter, Double-blind Phase 3 Study of Amcenestrant (SAR439859) Plus Palbociclib Versus Letrozole Plus Palbociclib for the Treatment of Patients With ER (+), HER2 (-) Breast Cancer Who Have Not Received Prior Systemic Anti-cancer Treatment for Advanced Disease
Secondary ID [1] 0 0
2020-001824-33
Secondary ID [2] 0 0
EFC15935
Universal Trial Number (UTN)
Trial acronym
AMEERA-5
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Amcenestrant-matching placebo
Treatment: Drugs - SAR439859
Treatment: Drugs - Palbociclib
Treatment: Drugs - Letrozole
Treatment: Drugs - Goserelin
Treatment: Drugs - Letrozole-matching placebo

Active comparator: Letrozole + Palbociclib - Participants received letrozole 2.5 milligrams (mg) capsule along with amcenestrant-matching placebo once daily, continuously and palbociclib 125 mg orally (PO), once daily (QD) from Day 1 to Day 21 of each 28-day treatment cycle until disease progression, death or study cut-off date, whichever comes first (maximum exposure: 112 weeks). Goserelin once every 4 weeks in pre/peri menopausal women and men.

Experimental: Amcenestrant + Palbociclib - Participants received amcenestrant 200 mg tablet along with letrozole-matching placebo once daily, continuously and palbociclib 125 mg PO, QD from Day 1 to Day 21 of each 28-day treatment cycle until disease progression, death, or study cut-off date, whichever comes first (maximum exposure: 109 weeks). Goserelin once every 4 weeks in pre/peri menopausal women and men.


Treatment: Drugs: Amcenestrant-matching placebo
Pharmaceutical form: Tablets Route of Administration: Oral

Treatment: Drugs: SAR439859
Pharmaceutical form: Tablets Route of Administration: Oral

Treatment: Drugs: Palbociclib
Pharmaceutical form: Capsules/Tablets Route of Administration: Oral

Treatment: Drugs: Letrozole
Pharmaceutical form: Capsules Route of Administration: Orally

Treatment: Drugs: Goserelin
Pharmaceutical form: Depot Injection Route of Administration: Subcutaneous

Treatment: Drugs: Letrozole-matching placebo
Pharmaceutical form: Capsules Route of Administration: Orally

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression-free Survival (PFS)
Assessment method [1] 0 0
PFS was defined as the time interval (in months) from the date of randomization to the date of first documented tumor progression as per Response Evaluation Criteria in Solid Tumors (RECIST 1.1) assessed by local radiologist or investigator, or death (due to any cause), whichever comes first. Progressive Disease (PD) as per RECIST 1.1: at least a 20 percent (%) increase in sum of diameters of target lesions, unequivocal progression of existing non-target lesions. Analysis was performed by Kaplan-Meier method.
Timepoint [1] 0 0
From randomization to the date of first documented tumor progression or death due to any cause or data cut-off date whichever comes first (maximum duration: 81 weeks)
Secondary outcome [1] 0 0
Overall Survival (OS)
Assessment method [1] 0 0
OS was defined as the interval (in months) from the date of randomization to the date of documented death (due to any cause). In the absence of observation of death, survival time was censored to last date the participant was known to be alive or at the cut-off date, whichever comes first. Analysis was performed by Kaplan-Meier method.
Timepoint [1] 0 0
From randomization to the death due to any cause or data cut-off date, whichever comes first (maximum duration: 81 weeks)
Secondary outcome [2] 0 0
12-month Progression-free Survival (PFS) Rate
Assessment method [2] 0 0
Percentage of participants who were disease progression-free at Month 12 after randomization were reported in this outcome measure. PFS was defined as the time interval (in months) from the date of randomization to the date of first documented tumor progression as per RECIST 1.1 assessed by local radiologist or investigator, or death (due to any cause), whichever comes first. PD as per RECIST 1.1: at least a 20% increase in sum of diameters of target lesions, unequivocal progression of existing non-target lesions. The PFS rate at Month 12 was estimated using the Kaplan-Meier method and provided an estimation of the percentage of participants who were disease progression-free at Month 12 after randomization.
Timepoint [2] 0 0
Month 12
Secondary outcome [3] 0 0
Percentage of Participants With Objective Response
Assessment method [3] 0 0
Objective response was defined as percentage of participants having a partial response (PR) or complete response (CR) according to the RECIST version 1.1 assessed by investigator. As per RECIST 1.1, CR was defined as disappearance of all target and non-target lesions and normalization of tumor marker level. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (\<) 10 millimeters (mm). PR was defined as at least a 30%decrease in the sum of diameters of target lesions, taking as reference the Baseline sum diameters.
Timepoint [3] 0 0
From randomization to the date of first documented tumor progression, death due to any cause or data cut-off date whichever comes first (maximum duration: 81 weeks)
Secondary outcome [4] 0 0
Duration of Response (DOR)
Assessment method [4] 0 0
DOR was defined as time (in months) from first documented evidence of CR or PR until disease progression determined by investigator as per RECIST 1.1, or start of any anti-cancer therapy, or death from any cause, whichever occurs first. For participants with ongoing response at the time of the analysis, DOR was censored at the date of the last valid disease assessment not showing documented progression performed before the initiation of a new anticancer treatment (if any). As per RECIST 1.1, CR was defined as disappearance of all target and non-target lesions and normalization of tumor marker level. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the Baseline sum diameters. PD: at least 20% increase in sum of diameters of target lesions, unequivocal progression of existing non-target lesions. Analysis was performed by Kaplan-Meier method.
Timepoint [4] 0 0
From the date of first response of CR or PR until disease progression or death, or start of any anti-cancer therapy or data cut-off date, whichever comes first (maximum duration: 81 weeks)
Secondary outcome [5] 0 0
Percentage of Participants With Clinical Benefit
Assessment method [5] 0 0
Clinical Benefit was defined as the percentage of participants having a confirmed CR, PR, or stable disease (SD) for at least 24 weeks determined by investigator as per RECIST 1.1, from date of randomization until disease progression, or death, or data cut-off date, or initiation of post treatment anti-cancer therapy, whichever occurs first. As per RECIST 1.1; CR was defined as disappearance of all target, non-target lesions \& normalization of tumor marker level. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR: at least a 30% decrease in sum of diameters of target lesions, taking as reference Baseline sum diameters. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference smallest sum diameters. PD: at least 20% increase in sum of diameters of target lesions, unequivocal progression of existing non-target lesions.
Timepoint [5] 0 0
From randomization until disease progression, or death, or data cut-off date, whichever comes first (maximum duration: 81 weeks)
Secondary outcome [6] 0 0
Progression-free Survival on Next Line of Therapy (PFS2)
Assessment method [6] 0 0
PFS2 was defined as the time interval (in months) from the date of randomization to the date of first documentation of PD on the next systemic anti-cancer therapy according to investigator, or death due to any cause in the absence of documented PD on the next systemic anti-cancer therapy, whichever occurs first. PD was defined as at least 20% increase in sum of diameters of target lesions, unequivocal progression of existing non-target lesions. Analysis was performed by Kaplan-Meier method.
Timepoint [6] 0 0
From randomization to date first documented disease progression on the next systemic anti-cancer therapy, or death due to any cause, or data cut-off date, whichever comes first (maximum duration: 81 weeks)
Secondary outcome [7] 0 0
Pharmacokinetics: Plasma Concentrations of Amcenestrant
Assessment method [7] 0 0
Amcenestrant plasma concentrations at specified time points were reported. Data for this outcome measure was not planned to be collected and analyzed for Letrozole+Palbociclib arm as pre-specified in protocol.
Timepoint [7] 0 0
Cycle 1 Day 1: 3 hours (hr) post-dose, Cycle 1 Day 15: pre-dose, Cycle 2 Day 1: pre-dose, 3 hr post-dose, Cycle 2 Day 15: pre-dose, Cycle 3 Day 1: pre-dose, Cycle 4 Day 1: pre-dose, Cycle 7 Day 1: pre-dose, Cycle 10 Day 1: pre-dose
Secondary outcome [8] 0 0
Pharmacokinetics: Plasma Concentrations of Palbociclib
Assessment method [8] 0 0
Palbociclib plasma concentrations at specified time points were reported.
Timepoint [8] 0 0
Cycle 1 Day 1: 3 hr post-dose, Cycle 1 Day 15: pre-dose, Cycle 2 Day 1: pre-dose, 3 hr post-dose, Cycle 2 Day 15: pre-dose, Cycle 3 Day 1: pre-dose, Cycle 4 Day 1: pre-dose, Cycle 7 Day 1: pre-dose, Cycle 10 Day 1: pre-dose
Secondary outcome [9] 0 0
Change From Baseline in European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC-QLQ-C30) Domain Scores
Assessment method [9] 0 0
EORTC-QLQ-C30: cancer-specific instrument with 30 questions for evaluation of new chemotherapy \& assessment of participant reported outcome. These include 5 functional scales, 9 symptom scales, \& Global Health Status/quality of life scale (GHS/QoL). All 14 items/domains were scored on scale of 1 (not at all) to 4 (very much) \& GHS/QoL, scored on scale of 1 (very poor) to 7 (excellent). All scales are transformed from raw scores to linear scales ranging 0 to 100. Higher score for functional \& GHS/QoL=higher level of functioning, \& higher score for symptoms scales=higher symptom burden. Least Square (LS) mean and Standard Error (SE) were derived from MMRM model with change from Baseline values as response variable, treatment, time, treatment-by-time interaction, Baseline value and stratifications factors as fixed effect. Average of LS mean change from Baseline values of overall treatment (i.e., each cycle \[Cycle 1 up to Cycle 21\]) for each domain was reported in this outcome measure.
Timepoint [9] 0 0
Baseline, overall treatment duration (Cycle 1 up to Cycle 21 [i.e., 81 weeks])
Secondary outcome [10] 0 0
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Breast Cancer Specific Module (EORTC-QLQ-BR23) Domain Scores
Assessment method [10] 0 0
QLQ-BR23: disease-specific Health-related QOL assesses breast cancer impact \& side effects of treatment. EORTCQLQ- BR23 contains 23 items: multi-item scales \& single-item measures. 4 functional scales (body image, sexual functioning, sexual enjoyment, future perspective) \& 4 scales related to symptoms of disease or treatment (arm symptoms, breast symptoms, systemic therapy side effects, \& upset by hair loss). All items scored 1 (not at all) to 4 (very much). Scores of all scales transformed from raw scores to linear scales ranging 0-100. Higher score for functional scales=better outcome; higher score for symptoms scales=higher symptom burden. LS mean \& SE were derived from MMRM model with change from Baseline values as response variable, treatment, time, treatment-by-time interaction, Baseline value \& stratifications factors as fixed effect. Average of LS mean change from Baseline values of overall treatment (i.e., each cycle \[Cycle 1 up to Cycle 21\]) for each domain was reported.
Timepoint [10] 0 0
Baseline, overall treatment duration (Cycle 1 up to Cycle 21 [i.e., 81 weeks])
Secondary outcome [11] 0 0
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Breast Cancer Specific Module (EORTC QLQ-BR45) Domain Scores
Assessment method [11] 0 0
EORTC QLQ-BR45: comprised of all 23 items from the QLQ-BR23 plus an additional 22 items assessing endocrine therapy symptoms (10 items), endocrine sexual symptoms (4 items), breast satisfaction (2 items), and skin mucosis symptoms (6 items). All items scored 1 (not at all) to 4 (very much). Scores of all scales transformed from raw scores to linear scales ranging 0 to 100. Higher score for functional scales = better outcome; higher score for symptoms scales = higher symptom burden. LS mean and SE are derived from Mixed Model Repeated Measures (MMRM) model with change from Baseline values as response variable, treatment, time, treatment-by-time interaction, Baseline value and stratifications factors as fixed effect. Average of LS mean change from Baseline values of overall treatment (i.e., each cycle \[Cycle 1 up to Cycle 21\]) for each domain (endocrine therapy symptoms, endocrine sexual symptoms, breast satisfaction and skin mucosis symptoms) was reported.
Timepoint [11] 0 0
Baseline, overall treatment duration (Cycle 1 up to Cycle 21 [i.e., 81 weeks])
Secondary outcome [12] 0 0
Change From Baseline in European Quality of Life Working Group Health Status Measure 5 Dimensions (5D), 5 Levels (5L) (EQ-5D-5L) Score: Visual Analog Scale (VAS) Score
Assessment method [12] 0 0
EQ-5D-5L is a standardized measure of health status, provides a simple, generic measure of health for clinical and economic appraisal, and consists of 2 sections: the EQ-5D-5L health state utility index (descriptive system) and the EQ-5D-5L VAS. The Visual Analogue Scale is designed to rate the participant's current health state on a scale from 0 to 100, where 0 represents the worst imaginable health state and 100 represents the best imaginable health state. LS mean and SE are derived from MMRM model with change from Baseline values as response variable, treatment, time, treatment-by-time interaction, Baseline value and stratifications factors as fixed effect. Average of LS mean change from Baseline values of overall treatment (i.e., each cycle \[Cycle 1 up to Cycle 21\]) for VAS was reported in this outcome measure.
Timepoint [12] 0 0
Baseline, overall treatment duration (Cycle 1 up to Cycle 21 [i.e., 81 weeks])
Secondary outcome [13] 0 0
Change From Baseline in European Quality of Life Working Group Health Status Measure 5 Dimensions (5D), 5 Levels (5L) (EQ-5D-5L) Score: Health Utility Index Value Score
Assessment method [13] 0 0
EQ-5D-5L: consists of 2 sections: EQ-5D-5L health state utility index (descriptive system) \& VAS. The EQ-5D descriptive system consists of 5 dimensions: mobility, self-care, usual activities, pain/discomfort \& anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, \& extreme problems. Response options are measured with 5-point Likert scale (for 5L version). The EQ-5D-5L responses are converted into single index utility score between 0 to 1, where higher score indicates better health state \& lower score indicate worse health state. LS mean and SE were derived from MMRM model with change from Baseline values as response variable, treatment, time, treatment-by-time interaction, Baseline value and stratifications factors as fixed effect. Average of LS mean change from Baseline values overall treatment (i.e., each cycle \[Cycle 1 up to Cycle 21\]) for health utility index value score was reported in this outcome measure.
Timepoint [13] 0 0
Baseline, overall treatment duration (Cycle 1 up to Cycle 21 [i.e., 81 weeks])
Secondary outcome [14] 0 0
Time to First Chemotherapy
Assessment method [14] 0 0
Time to chemotherapy was defined as the time interval (in months) from the date of randomization to the start date of the first chemotherapy after disease progression.
Timepoint [14] 0 0
From randomization to the start date of the first chemotherapy (maximum duration: 81 weeks)
Secondary outcome [15] 0 0
Number of Participants With Hematological Abnormalities During the Treatment Period
Assessment method [15] 0 0
Hematological parameters assessed were anemia, lymphocyte count decreased, neutrophil count decreased, white blood cell decreased, platelet count decreased. Parameters were assessed as per the National Cancer Institute Common Terminology Criteria for Adverse Experience version 5.0 (NCI-CTCAE v 5.0), where Grade 1 = Mild; Grade 2 = Moderate; Grade 3 = Severe; Grade 4 = Potentially Life Threatening. Grade refers to the severity of the AEs. Treatment period was defined as the time from the first dose of study treatments up to 30 days after last dose of study treatment.
Timepoint [15] 0 0
From first dose of study treatment up to 30 days after last dose of study treatment (maximum duration: 112 weeks)
Secondary outcome [16] 0 0
Number of Participants With Liver Function Abnormalities of Grade 3 and 4 During the Treatment Period
Assessment method [16] 0 0
Liver Function parameters assessed were aspartate aminotransferase increased, alanine aminotransferase increased, alkaline phosphatase increased, total bilirubin increased, gamma-glutamyl transferase increased. Parameters were assessed as per the NCI-CTCAE v 5.0, where Grade 1 = Mild; Grade 2 = Moderate; Grade 3 = Severe; Grade 4 = Potentially Life Threatening. Grade refers to the severity of the AEs. Treatment period was defined as the time from the first dose of study treatments up to 30 days after last dose of study treatment. Participants with Grade 3 and 4 liver function abnormalities were reported in this outcome measure.
Timepoint [16] 0 0
From first dose of study treatment up to 30 days after last dose of study treatment (maximum duration: 112 weeks)

Eligibility
Key inclusion criteria
Inclusion criteria :

* Adult participants with loco-regional recurrent or metastatic disease not amenable to curative treatment.
* Confirmed diagnosis of ER+/HER2- breast cancer.
* No prior systemic treatment for loco-regional recurrent or metastatic disease.
* Measurable disease evaluable per Response Evaluation Criterion in Solid Tumors (RECIST) v.1.1 or non-measurable bone-only disease.
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
* Participants should be willing to provide tumor tissue.
* Capable of giving informed consent.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:

* Known active brain metastases.
* Prior neo (adjuvant) treatment with any selective estrogen receptor degrader (SERD).
* Inadequate organ and marrow function.
* Disease recurrence while on, or within 12 months of completion of (neo)adjuvant endocrine therapy.
* Pregnant, breastfeeding, or woman of childbearing potential unwilling to use recommended contraception methods.
* Male participants who disagree to follow contraception.
* Participants with advanced, symptomatic visceral spread, that are at risk of life-threatening complications in the short term.
* Participants with significant concomitant illness.

The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

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 administering the treatment/s
The people assessing the outcomes
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC,WA
Recruitment hospital [1] 0 0
Investigational Site Number :0360004 - Macquarie Park
Recruitment hospital [2] 0 0
Investigational Site Number :0360005 - Randwick
Recruitment hospital [3] 0 0
Investigational Site Number :0360003 - Wahroonga
Recruitment hospital [4] 0 0
Investigational Site Number :0360002 - Richmond
Recruitment hospital [5] 0 0
Investigational Site Number :0360001 - Nedlands
Recruitment postcode(s) [1] 0 0
2109 - Macquarie Park
Recruitment postcode(s) [2] 0 0
2031 - Randwick
Recruitment postcode(s) [3] 0 0
2076 - Wahroonga
Recruitment postcode(s) [4] 0 0
3121 - Richmond
Recruitment postcode(s) [5] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Colorado
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Georgia
Country [7] 0 0
United States of America
State/province [7] 0 0
Illinois
Country [8] 0 0
United States of America
State/province [8] 0 0
Indiana
Country [9] 0 0
United States of America
State/province [9] 0 0
Iowa
Country [10] 0 0
United States of America
State/province [10] 0 0
Kansas
Country [11] 0 0
United States of America
State/province [11] 0 0
Maine
Country [12] 0 0
United States of America
State/province [12] 0 0
Massachusetts
Country [13] 0 0
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Michigan
Country [14] 0 0
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Missouri
Country [15] 0 0
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Nevada
Country [16] 0 0
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New Jersey
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New York
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North Carolina
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Oregon
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Pennsylvania
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United States of America
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Texas
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United States of America
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Virginia
Country [23] 0 0
Argentina
State/province [23] 0 0
Buenos Aires
Country [24] 0 0
Argentina
State/province [24] 0 0
Córdoba
Country [25] 0 0
Argentina
State/province [25] 0 0
Santa Fe
Country [26] 0 0
Argentina
State/province [26] 0 0
La Rioja
Country [27] 0 0
Argentina
State/province [27] 0 0
Mar del Plata
Country [28] 0 0
Argentina
State/province [28] 0 0
Salta
Country [29] 0 0
Austria
State/province [29] 0 0
Graz
Country [30] 0 0
Belgium
State/province [30] 0 0
Bruxelles
Country [31] 0 0
Belgium
State/province [31] 0 0
Charleroi
Country [32] 0 0
Belgium
State/province [32] 0 0
Leuven
Country [33] 0 0
Belgium
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Namur
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Brazil
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Rio Grande Do Sul
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Brazil
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São Paulo
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Brazil
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Rio De Janeiro
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Bulgaria
State/province [37] 0 0
Burgas
Country [38] 0 0
Bulgaria
State/province [38] 0 0
Dobrich
Country [39] 0 0
Bulgaria
State/province [39] 0 0
Russe
Country [40] 0 0
Bulgaria
State/province [40] 0 0
Sofia
Country [41] 0 0
Canada
State/province [41] 0 0
Ontario
Country [42] 0 0
Canada
State/province [42] 0 0
Quebec
Country [43] 0 0
Chile
State/province [43] 0 0
Coquimbo
Country [44] 0 0
Chile
State/province [44] 0 0
La Araucanía
Country [45] 0 0
Chile
State/province [45] 0 0
Maule
Country [46] 0 0
Chile
State/province [46] 0 0
Reg Metropolitana De Santiago
Country [47] 0 0
Chile
State/province [47] 0 0
Valparaíso
Country [48] 0 0
Chile
State/province [48] 0 0
Santiago de Chile
Country [49] 0 0
Chile
State/province [49] 0 0
Santiago
Country [50] 0 0
China
State/province [50] 0 0
Baoding
Country [51] 0 0
China
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Beijing
Country [52] 0 0
China
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Changchun
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China
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Chengdu
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China
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Chongqing
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China
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Dalian
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China
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Deyang
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China
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Fuzhou
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China
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Guangzhou
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China
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Hangzhou
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China
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Harbin
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China
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Hefei
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China
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Jinan
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China
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Jining
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China
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Linyi
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China
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Luoyang
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China
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Neijiang
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China
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Shanghai
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China
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Shaoguan
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China
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Tianjin
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China
State/province [70] 0 0
Wuhan
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China
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Xi'an
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China
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Xi'An
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China
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Xuzhou
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China
State/province [74] 0 0
Yantai
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China
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Zhengzhou
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Czechia
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Brno
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Czechia
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Praha 2
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Finland
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Helsinki
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Finland
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Tampere
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Finland
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Turku
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France
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Nice
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France
State/province [82] 0 0
Paris
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France
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Poitiers
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France
State/province [84] 0 0
Saint Cloud
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France
State/province [85] 0 0
Saint-Herblain
Country [86] 0 0
France
State/province [86] 0 0
Strasbourg
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France
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TOULOUSE Cedex 9
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France
State/province [88] 0 0
Villejuif
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Georgia
State/province [89] 0 0
Batumi
Country [90] 0 0
Georgia
State/province [90] 0 0
Kutaisi
Country [91] 0 0
Georgia
State/province [91] 0 0
Tbilisi
Country [92] 0 0
Germany
State/province [92] 0 0
Bottrop
Country [93] 0 0
Germany
State/province [93] 0 0
Münster
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Germany
State/province [94] 0 0
Oldenburg in Holstein
Country [95] 0 0
Germany
State/province [95] 0 0
Ulm
Country [96] 0 0
Hungary
State/province [96] 0 0
Budapest
Country [97] 0 0
Hungary
State/province [97] 0 0
Gyula
Country [98] 0 0
Hungary
State/province [98] 0 0
Gyor
Country [99] 0 0
Hungary
State/province [99] 0 0
Kaposvár
Country [100] 0 0
Hungary
State/province [100] 0 0
Kecskemét
Country [101] 0 0
Hungary
State/province [101] 0 0
Miskolc
Country [102] 0 0
Hungary
State/province [102] 0 0
Nyíregyháza
Country [103] 0 0
Italy
State/province [103] 0 0
Emilia-Romagna
Country [104] 0 0
Italy
State/province [104] 0 0
Milano
Country [105] 0 0
Italy
State/province [105] 0 0
Monza E Brianza
Country [106] 0 0
Italy
State/province [106] 0 0
Bologna
Country [107] 0 0
Italy
State/province [107] 0 0
Napoli
Country [108] 0 0
Italy
State/province [108] 0 0
Prato
Country [109] 0 0
Japan
State/province [109] 0 0
Aichi
Country [110] 0 0
Japan
State/province [110] 0 0
Chiba
Country [111] 0 0
Japan
State/province [111] 0 0
Ehime
Country [112] 0 0
Japan
State/province [112] 0 0
Fukuoka
Country [113] 0 0
Japan
State/province [113] 0 0
Gunma
Country [114] 0 0
Japan
State/province [114] 0 0
Hiroshima
Country [115] 0 0
Japan
State/province [115] 0 0
Hokkaido
Country [116] 0 0
Japan
State/province [116] 0 0
Kagoshima
Country [117] 0 0
Japan
State/province [117] 0 0
Kanagawa
Country [118] 0 0
Japan
State/province [118] 0 0
Miyagi
Country [119] 0 0
Japan
State/province [119] 0 0
Miyazaki
Country [120] 0 0
Japan
State/province [120] 0 0
Osaka
Country [121] 0 0
Japan
State/province [121] 0 0
Saitama
Country [122] 0 0
Japan
State/province [122] 0 0
Shizuoka
Country [123] 0 0
Japan
State/province [123] 0 0
Tokyo
Country [124] 0 0
Korea, Republic of
State/province [124] 0 0
Gyeonggi-do
Country [125] 0 0
Korea, Republic of
State/province [125] 0 0
Seoul-teukbyeolsi
Country [126] 0 0
Korea, Republic of
State/province [126] 0 0
Seochogu
Country [127] 0 0
Korea, Republic of
State/province [127] 0 0
Seongnam-si, Gyeonggi-do
Country [128] 0 0
Netherlands
State/province [128] 0 0
Arnhem
Country [129] 0 0
Netherlands
State/province [129] 0 0
Delft
Country [130] 0 0
Netherlands
State/province [130] 0 0
Maastricht
Country [131] 0 0
Poland
State/province [131] 0 0
Lódzkie
Country [132] 0 0
Poland
State/province [132] 0 0
Wielkopolskie
Country [133] 0 0
Portugal
State/province [133] 0 0
Almada
Country [134] 0 0
Portugal
State/province [134] 0 0
Lisboa
Country [135] 0 0
Portugal
State/province [135] 0 0
Porto
Country [136] 0 0
Russian Federation
State/province [136] 0 0
Arkhangelsk
Country [137] 0 0
Russian Federation
State/province [137] 0 0
Krasnogorskiy District
Country [138] 0 0
Russian Federation
State/province [138] 0 0
Moscow Region
Country [139] 0 0
Russian Federation
State/province [139] 0 0
Moscow
Country [140] 0 0
Russian Federation
State/province [140] 0 0
Saint -Petersburg
Country [141] 0 0
Russian Federation
State/province [141] 0 0
Saint Petersburg
Country [142] 0 0
Singapore
State/province [142] 0 0
Singapore
Country [143] 0 0
South Africa
State/province [143] 0 0
Cape Town
Country [144] 0 0
South Africa
State/province [144] 0 0
Johannesburg
Country [145] 0 0
Spain
State/province [145] 0 0
Barcelona [Barcelona]
Country [146] 0 0
Spain
State/province [146] 0 0
Castilla Y León
Country [147] 0 0
Spain
State/province [147] 0 0
Galicia [Galicia]
Country [148] 0 0
Spain
State/province [148] 0 0
Madrid, Comunidad De
Country [149] 0 0
Spain
State/province [149] 0 0
Valenciana, Comunidad
Country [150] 0 0
Spain
State/province [150] 0 0
Madrid
Country [151] 0 0
Spain
State/province [151] 0 0
Málaga
Country [152] 0 0
Spain
State/province [152] 0 0
Valencia
Country [153] 0 0
Taiwan
State/province [153] 0 0
Kaohsiung
Country [154] 0 0
Taiwan
State/province [154] 0 0
Tainan
Country [155] 0 0
Taiwan
State/province [155] 0 0
Taipei
Country [156] 0 0
Turkey
State/province [156] 0 0
Adana
Country [157] 0 0
Turkey
State/province [157] 0 0
Ankara
Country [158] 0 0
Turkey
State/province [158] 0 0
Antalya
Country [159] 0 0
Turkey
State/province [159] 0 0
Bornova
Country [160] 0 0
Turkey
State/province [160] 0 0
Diyarbakir
Country [161] 0 0
Turkey
State/province [161] 0 0
Edirne
Country [162] 0 0
Turkey
State/province [162] 0 0
Istanbul
Country [163] 0 0
Turkey
State/province [163] 0 0
Izmir
Country [164] 0 0
Turkey
State/province [164] 0 0
Kocaeli
Country [165] 0 0
Turkey
State/province [165] 0 0
Malatya
Country [166] 0 0
Ukraine
State/province [166] 0 0
Kharkiv
Country [167] 0 0
Ukraine
State/province [167] 0 0
Kryvyi Rih
Country [168] 0 0
Ukraine
State/province [168] 0 0
Odesa
Country [169] 0 0
Ukraine
State/province [169] 0 0
Vinnytsia
Country [170] 0 0
United Kingdom
State/province [170] 0 0
Central Bedfordshire
Country [171] 0 0
United Kingdom
State/province [171] 0 0
Edinburgh, City Of
Country [172] 0 0
United Kingdom
State/province [172] 0 0
Lancashire

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Sanofi
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Sciences & Operations
Address 0 0
Sanofi
Country 0 0
Phone 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 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?
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

Results publications and other study-related documents

No documents have been uploaded by study researchers.