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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT04251533
Registration number
NCT04251533
Ethics application status
Date submitted
30/01/2020
Date registered
5/02/2020
Titles & IDs
Public title
Study Assessing the Efficacy and Safety of Alpelisib + Nab-paclitaxel in Subjects With Advanced TNBC Who Carry Either a PIK3CA Mutation or Have PTEN Loss
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Scientific title
A Phase III, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of Alpelisib (BYL719) in Combination With Nab-paclitaxel in Patients With Advanced Triple Negative Breast Cancer With Either Phosphoinositide-3-kinase Catalytic Subunit Alpha (PIK3CA) Mutation or Phosphatase and Tensin Homolog Protein (PTEN) Loss Without PIK3CA Mutation
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Secondary ID [1]
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2019-002637-11
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Secondary ID [2]
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CBYL719H12301
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Universal Trial Number (UTN)
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Trial acronym
EPIK-B3
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Triple Negative Breast Neoplasms
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Condition category
Condition code
Cancer
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Breast
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - alpelisib
Treatment: Drugs - placebo
Treatment: Drugs - nab-paclitaxel
Experimental: Part A: alpelisib + nab-paclitaxel - Participants received alpelisib 300 mg orally + nab-paclitaxel 100 mg/m\^2 intravenously (IV) on Days 1, 8, and 15 of each 28-day cycle
Placebo comparator: Part A: placebo + nab-paclitaxel - Participants received placebo + nab-paclitaxel 100 mg/m\^2 IV on Days 1, 8, and 15 of each 28-day cycle.
Experimental: Part B1: alpelisib + nab-paclitaxel - Participants received alpelisib 300 mg orally + nab-paclitaxel 100 mg/m\^2 IV on Days 1, 8, and 15 of each 28-day cycle.
Treatment: Drugs: alpelisib
300 mg orally, once per day (QD), tablets
Treatment: Drugs: placebo
300 mg orally, once per day (QD), tablets
Treatment: Drugs: nab-paclitaxel
100 mg/m\^2 IV infusion, once per day (QD)
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Progression-free Survival (PFS) Per Investigator Assessment in Study Part A
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Assessment method [1]
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PFS was defined as time from the date of randomization to the date of the first documented progressive disease (PD) or death due to any cause. PFS was assessed via a local radiology assessment according to RECIST 1.1. PD=At least a 20% increase in the sum of diameter of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm\^2. PFS was censored at the date of the last adequate tumor assessment, if no PFS event was observed prior to the analysis cut-off date.
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Timepoint [1]
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Once all participants have completed at least 6 months of study treatment or have discontinued from study treatment, up to 35 months
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Primary outcome [2]
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Progression-free Survival (PFS) Per Investigator Assessment in Study Part B2
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Assessment method [2]
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PFS was defined as time from the date of randomization to the date of the first documented progression or death due to any cause. PFS was planned to be assessed via a local radiology assessment according to RECIST 1.1.
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Timepoint [2]
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Once approximately 192 PFS events in Study Part B2 had been observed, up to 22 months
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Primary outcome [3]
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Overall Response Rate (ORR) Based on Local Radiology Assessments in Participants With Measurable Disease at Baseline in Study Part B1
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Assessment method [3]
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ORR was defined as the percentage of participants with best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST 1.1. BOR was defined as the best response recorded from the start of the study treatment until progressive disease (PD)/recurrence. CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm. PR= At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters; PD= At least a 20% increase in the sum of diameters of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline. In addition, the sum must also demonstrate an absolute increase of at least 5 mm.
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Timepoint [3]
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Up to 6 months
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Secondary outcome [1]
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Overall Survival in Study Part A
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Assessment method [1]
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Overall survival is defined as the time from date of randomization to date of death due to any cause.
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Timepoint [1]
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Up to 66 months
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Secondary outcome [2]
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Overall Survival in Study Part B2
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Assessment method [2]
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Overall survival was defined as the time from date of randomization to date of death due to any cause.
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Timepoint [2]
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Up to 41 months
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Secondary outcome [3]
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Overall Response Rate (ORR) With Confirmed Response in Study Part A
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Assessment method [3]
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ORR with confirmed response was the percentage of participants with best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR), as per local review and according to RECIST 1.1. BOR was defined as the best response recorded from the start of the study treatment until progressive disease (PD)/recurrence. CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm. PR= At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters; PD= At least a 20% increase in the sum of diameters of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline. In addition, the sum must also demonstrate an absolute increase of at least 5 mm.
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Timepoint [3]
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Once all participants have completed at least 6 months of study treatment or have discontinued from study treatment, up to 35 months
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Secondary outcome [4]
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Overall Response Rate (ORR) With Confirmed Response in Study Part B2
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Assessment method [4]
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ORR with confirmed response was the percentage of participants with BOR of confirmed complete response (CR) or confirmed partial response (PR), as per local review and according to RECIST 1.1.
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Timepoint [4]
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Up to 22 months
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Secondary outcome [5]
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Clinical Benefit Rate (CBR) With Confirmed Response in Study Part A
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Assessment method [5]
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Clinical benefit rate (CBR) was defined as the percentage of participants with a best overall response of complete response (CR), or partial response (PR) or an overall lesion response of stable disease (SD), lasting as per local review, for a duration of at least 24 weeks. CR, PR and SD are defined according to RECIST 1.1 based on investigator's assessment. CR: Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters. SD: Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for progressive disease.
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Timepoint [5]
0
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Once all participants have completed at least 6 months of study treatment or have discontinued from study treatment, up to 35 months
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Secondary outcome [6]
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Clinical Benefit Rate (CBR) With Confirmed Response in Study Part B1
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Assessment method [6]
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Clinical benefit rate (CBR) was defined as the percentage of participants with a best overall response of complete response (CR), or partial response (PR) or an overall lesion response of stable disease (SD), lasting as per local review, for a duration of at least 24 weeks. CR, PR and SD are defined according to RECIST 1.1 based on investigator's assessment. CR: Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters. SD: Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for progressive disease.
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Timepoint [6]
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Up to 6 months
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Secondary outcome [7]
0
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Clinical Benefit Rate (CBR) With Confirmed Response in Study Part B2
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Assessment method [7]
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Clinical benefit rate (CBR) with confirmed response was defined as the percentage of participants with a best overall response of confirmed complete response (CR), or confirmed partial response (PR), or an overall response of stable disease (SD) lasting for a duration of at least 24 weeks. CR, PR, and SD were defined as per local review according to RECIST 1.1.
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Timepoint [7]
0
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Up to 22 months
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Secondary outcome [8]
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Time to Response (TTR) in Study Part A
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Assessment method [8]
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Time to response (TTR) was defined as the time from the date of randomization/enrolment to the first documented response of either complete response (CR) or partial response (PR), which must be subsequently confirmed (although date of initial response is used, not date of confirmation). CR and PR were based on tumor response data as per local review and according to RECIST 1.1. CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm; PR= At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters.
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Timepoint [8]
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Once all participants have completed at least 6 months of study treatment or have discontinued from study treatment, up to 35 months
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Secondary outcome [9]
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Time to Response (TTR) in Study Part B1
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Assessment method [9]
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Time to response (TTR) was defined as the time from the date of randomization/enrolment to the first documented response of either complete response (CR) or partial response (PR), which must be subsequently confirmed (although date of initial response was used, not date of confirmation). CR and PR were based on tumor response data as per local review and according to RECIST 1.1. CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm; PR= At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters.
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Timepoint [9]
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Up to 6 months
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Secondary outcome [10]
0
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Time to Response (TTR) in Study Part B2
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Assessment method [10]
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Time to response (TTR) was defined as the time from the date of randomization/enrolment to the first documented response of either complete response (CR) or partial response (PR), which must be subsequently confirmed (although date of initial response was used, not date of confirmation). CR and PR were based on tumor response data as per local review and according to RECIST 1.1.
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Timepoint [10]
0
0
Up to 22 months
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Secondary outcome [11]
0
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Duration of Response (DOR) With Confirmed Response in Study Part A
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Assessment method [11]
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Duration of response (DOR) with confirmed response only applied to participants whose best overall response (BOR) was confirmed complete response (CR) or confirmed partial response (PR) according to RECIST 1.1 based on tumor response data per local review. The start date was the date of first documented response of CR or PR (i.e. the start date of response, not the date when response was confirmed), and the end date was defined as the date of the first documented progressive disease (PD) or death due to underlying cancer. CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm; PR= At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters.
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Timepoint [11]
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Once all participants have completed at least 6 months of study treatment or have discontinued from study treatment, up to 35 months
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Secondary outcome [12]
0
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Duration of Response (DOR) With Confirmed Response in Study Part B1
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Assessment method [12]
0
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Duration of response (DOR) with confirmed response only applied to participants whose best overall response (BOR) was confirmed complete response (CR) or confirmed partial response (PR) according to RECIST 1.1 based on tumor response data per local review. The start date was the date of first documented response of CR or PR (i.e. the start date of response, not the date when response was confirmed), and the end date was defined as the date of the first documented progressive disease (PD) or death due to underlying cancer. CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm; PR= At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters.
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Timepoint [12]
0
0
Up to approximately 20 months
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Secondary outcome [13]
0
0
Duration of Response (DOR) With Confirmed Response in Study Part B2
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Assessment method [13]
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Duration of response (DOR) with confirmed response only applied to participants whose best overall response was confirmed complete response (CR) or confirmed partial response (PR) according to RECIST 1.1 based on tumor response data per local review. The start date was the date of first documented response of CR or PR (i.e. the start date of response, not the date when response was confirmed), and the end date was defined as the date of the first documented progression or death due to underlying cancer.
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Timepoint [13]
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Up to 22 months
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Secondary outcome [14]
0
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Overall Survival in Study Part B1
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Assessment method [14]
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Overall survival for Part B1 was defined as the number of participants who were alive at the end of the post-treatment period.
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Timepoint [14]
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Up to approximately 26 months.
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Secondary outcome [15]
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Progression-free Survival (PFS) Per Investigator Assessment in Study Part B1
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Assessment method [15]
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PFS was defined as time from the date of enrolment to the date of the first documented progressive disease (PD) or death due to any cause. PFS was assessed via a local radiology assessment according to RECIST 1.1. PD=At least a 20% increase in the sum of diameter of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm\^2. PFS was censored at the date of the last adequate tumor assessment, if no PFS event was observed prior to the analysis cut-off date.
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Timepoint [15]
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Up to 6 months
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Secondary outcome [16]
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Plasma Concentrations of Alpelisib in Study Part B2
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Assessment method [16]
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Summary statistics of plasma alpelisib concentrations by time point
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Timepoint [16]
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Up to 22 months
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Secondary outcome [17]
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Change From Baseline in the Global Health Status/QoL Scale Score of the EORTC QLQ-C30 in Study Part B2
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Assessment method [17]
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Summary of composite measure of change from baseline in the domain scores, health states, overall health status, and index values at the time of each assessment. global health status/QOL scale score of EORTC QLQ-C30, a questionnaire to assess the quality of life of cancer patients. The questionnaire contains 30 items \& is composed of both multi-item scales \& single-item measures based on the patient's experience over the past week. This includes 5 functional scales, 3 symptom scales, 6 single items \& a global health status/QoL scale. The scales \& single-item measures range in score from 0 - 100. A high scale score represents a higher response level. A high score for a functional scale represents a high/healthy level of functioning; a high score for the global health status/QoL represents a high QoL, but a high score for a symptom scale/item represents a high level of symptomatology/problems.
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Timepoint [17]
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Up to 22 months
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Secondary outcome [18]
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Time to 10% Definitive Deterioration in the Global Health Status/QOL Scale Score of the EORTC QLQ-C30 in Study Part B2
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Assessment method [18]
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Definitive deterioration: time from date of randomization to date of event, defined as at least a 10% worsening from baseline with no later improvement above this threshold observed during the course of the treatment or until death due to any cause, in the global health status/QOL scale score of EORTC QLQ-C30, a questionnaire to assess the quality of life of cancer patients. The questionnaire contains 30 items \& is composed of both multi-item scales \& single-item measures based on the patient's experience over the past week. This includes 5 functional scales, 3 symptom scales, 6 single items \& a global health status/QoL scale. The scales \& single-item measures range in score from 0 - 100. A high scale score represents a higher response level. A high score for a functional scale represents a high/healthy level of functioning; a high score for the global health status/QoL represents a high QoL, but a high score for a symptom scale/item represents a high level of symptomatology/problems.
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Timepoint [18]
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Up to 22 months
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Secondary outcome [19]
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PFS Based on Local Radiology Assessments Using RECIST 1.1 Criteria for Participants by PIK3CA Mutation Status Measured in Baseline Circulating Tumor Deoxyribonucleic Acid (ctDNA) in Study Part A
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Assessment method [19]
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PFS in participants with PIK3CA mutation as measured in ctDNA. PFS was defined as time from the date of randomization to the date of the first documented progression or death due to any cause.
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Timepoint [19]
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Once all participants have completed at least 6 months of study treatment or have discontinued from study treatment, up to 35 months
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Secondary outcome [20]
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PFS Based on Local Radiology Assessments Using RECIST 1.1 Criteria for Participants by PIK3CA Mutation Status Measured in Baseline ctDNA in Study Part B2
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Assessment method [20]
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PFS in participants with PIK3CA mutation as measured in ctDNA. PFS was defined as time from the date of randomization to the date of the first documented progression or death due to any cause.
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Timepoint [20]
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Up to 22 months
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Secondary outcome [21]
0
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Time to Definitive Deterioration of the ECOG Performance Status From Baseline in Study Part B2
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Assessment method [21]
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Definitive deterioration of ECOG PS was defined as the time from the date of randomization to the date of event defined as a worsening of at least once category from baseline in ECOG PS with no later improvement above this threshold observed during the course of the treatment or until death due to any cause.
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Timepoint [21]
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Up to 22 months
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Secondary outcome [22]
0
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Post-Hoc: All Collected Deaths
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Assessment method [22]
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On-treatment deaths due to any cause were collected from first dose of study medication to 30 days after the last dose of study treatment. Post-treatment survival follow-up deaths were collected from Day 31 after last dose of study medication to the data cut-off date.
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Timepoint [22]
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On-treatment deaths: Up to approximately 28 months (Part A) or approximately 17 months (Part B1). Post-treatment survival follow-up deaths: Up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1).
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Eligibility
Key inclusion criteria
* Participant has histologically confirmed diagnosis of advanced (loco-regionally recurrent and not amenable to curative therapy), or metastatic (stage IV) TNBC
* Participant has either a measurable disease per RECIST 1.1 criteria or, if no measurable disease is present, then at least one predominantly lytic bone lesion or mixed lytic-blastic bone lesion with identifiable soft tissue component (that can be evaluated by CT/MRI) must be present. Part B1: Participants must have measurable disease
* Participant has adequate tumor tissue to identify the PIK3CA mutation status (either carrying a mutation or without a mutation) and the PTEN loss status; both of which will determine whether the subject can be allocated to Part A - PIK3CA mutation regardless of PTEN status; or to Part B1 - PTEN loss or to Part B2 - PTEN loss without a PIK3CA mutation
* Participant has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Participant has received no more than one line of therapy for metastatic disease
* Participant has adequate bone marrow and organ function
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Participant has received prior treatment with any PI3K, mTOR or AKT inhibitor
* Participant has a known hypersensitivity to alpelisib, nab-paclitaxel or to any of their excipients
* Participant has not recovered from all toxicities related to prior anticancer therapies to NCI CTCAE version 4.03 Grade =1; with the exception of alopecia
* Participant has central nervous system (CNS) involvement which was not previously treated and/or was newly detected at screening
* Participant with an established diagnosis of diabetes mellitus type I or uncontrolled type II based on Fasting Plasma Glucose and HbA1c
* Participant has impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of the study drugs (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection) based on investigator discretion
* Participant has a history of acute pancreatitis within 1 year prior to screening or past medical history of chronic pancreatitis
* Participant has currently documented pneumonitis/interstitial lung disease
* Participant has a history of severe cutaneous reactions, such as Steven-Johnson Syndrome (SJS), erythema multiforme (EM),Toxic Epidermal Necrolysis (TEN) or Drug Reaction with Eosinophilia and Systemic Syndrome (DRESS)
* Participant with unresolved osteonecrosis of the jaw
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
8/06/2020
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
31/01/2025
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Actual
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Sample size
Target
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Accrual to date
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Final
137
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Recruitment in Australia
Recruitment state(s)
VIC,WA
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Recruitment hospital [1]
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0
Novartis Investigative Site - Melbourne
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Recruitment hospital [2]
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0
Novartis Investigative Site - Nedlands
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Recruitment postcode(s) [1]
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3000 - Melbourne
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Recruitment postcode(s) [2]
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6009 - Nedlands
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Recruitment outside Australia
Country [1]
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0
United States of America
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State/province [1]
0
0
California
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Country [2]
0
0
United States of America
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State/province [2]
0
0
Louisiana
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Country [3]
0
0
United States of America
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State/province [3]
0
0
Minnesota
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Country [4]
0
0
United States of America
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State/province [4]
0
0
Tennessee
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Country [5]
0
0
Argentina
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State/province [5]
0
0
Buenos Aires
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Country [6]
0
0
Argentina
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State/province [6]
0
0
Santa Fe
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Country [7]
0
0
Austria
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State/province [7]
0
0
Tyrol
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Country [8]
0
0
Austria
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State/province [8]
0
0
Leoben
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Country [9]
0
0
Brazil
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State/province [9]
0
0
SP
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Country [10]
0
0
Bulgaria
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State/province [10]
0
0
Plovdiv
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Country [11]
0
0
China
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State/province [11]
0
0
Anhui
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Country [12]
0
0
China
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State/province [12]
0
0
Hebei
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Country [13]
0
0
China
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State/province [13]
0
0
Hunan
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Country [14]
0
0
China
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State/province [14]
0
0
Jiangsu
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Country [15]
0
0
China
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State/province [15]
0
0
Jilin
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Country [16]
0
0
China
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State/province [16]
0
0
Liaoning
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Country [17]
0
0
China
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State/province [17]
0
0
Sichuan
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Country [18]
0
0
China
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State/province [18]
0
0
Zhejiang
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Country [19]
0
0
China
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State/province [19]
0
0
Dalian
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Country [20]
0
0
China
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State/province [20]
0
0
Shanghai
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Country [21]
0
0
China
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State/province [21]
0
0
Shenyang
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Country [22]
0
0
China
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State/province [22]
0
0
Tianjin
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Country [23]
0
0
Colombia
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State/province [23]
0
0
Bogota
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Country [24]
0
0
Croatia
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State/province [24]
0
0
Zagreb
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Country [25]
0
0
France
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State/province [25]
0
0
Hauts De Seine
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Country [26]
0
0
France
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State/province [26]
0
0
Angers Cedex 02
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Country [27]
0
0
France
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State/province [27]
0
0
Saint-Herblain
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Country [28]
0
0
France
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State/province [28]
0
0
Villejuif
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United Kingdom
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Funding & Sponsors
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Name
Novartis Pharmaceuticals
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Summary
Brief summary
The purpose of this study was to determine whether treatment with alpelisib in combination with nab-paclitaxel is safe and effective in subjects with advanced triple negative breast cancer (aTNBC) who carry either a PIK3CA mutation (Study Part A) or have PTEN loss (Study Part B1) or PTEN loss without PIK3CA mutation (Study Part B2)
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Trial website
https://clinicaltrials.gov/study/NCT04251533
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Contacts
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Novartis Pharmaceuticals
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Novartis Pharmaceuticals
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
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
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When will data be available (start and end dates)?
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Available to whom?
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Available for what types of analyses?
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How or where can data be obtained?
IPD available at link: https://www.clinicalstudydatarequest.com
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What supporting documents are/will be available?
No Supporting Document Provided
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Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/33/NCT04251533/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/33/NCT04251533/SAP_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT04251533