TriangleNCT01847274 · OUTCOME
Progression-Free Survival (PFS) in Cohort With Germline BReast CAncer Gene (BRCA) Mutation (gBRCA)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- months
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- From date of randomization to the earliest date of disease progression or death from any cause, up to 7 years 7 months and 4 days
What was measured
PFS was defined as the time between randomization and disease progression or death from any cause. Computed tomography or magnetic resonance imaging to assess disease progression was performed at baseline, every 8 weeks through cycle 14, and then every 12 weeks until treatment discontinuation. The objective assessment of disease progression was determined by means of central radiologic and clinical review, according to Response Evaluation Criteria in Solid Tumors (RECIST),version 1.1, which was performed in a blinded fashion. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study.
Analysis population: Intent-to-treat population was defined as all randomized participants with participants analyzed according to the study drug assigned via randomization
Groups in this outcome
gBRCA Niraparib
Participants with germline breast cancer gene (gBRCA) mutation received oral dose of niraparib 300 milligrams (mg) once daily in 28-day cycles until disease progression.
gBRCA Placebo
Participants with germline BRCA mutation received oral dose of placebo matching niraparib once daily in 28-day cycles until disease progression.
| Group | Source count |
|---|---|
| gBRCA Niraparib | 138 |
| gBRCA Placebo | 65 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| gBRCA Niraparib | 21 | Not reported | 12.9 | NA | Upper limit of confidence interval (CI) was not estimable as upper limits of CI for survivor function were above 0.5 (SAS PROC LIFETEST). |
| gBRCA Placebo | 5.5 | Not reported | 3.8 | 7.2 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.173
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.410
- estimate Comment
- Niraparib:Placebo, based on the stratified Cox Proportional Hazards Model using randomization stratification factors.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- <0.0001
- p Value Comment
- Two-sided P-value. PFS was independently evaluated in gBRCAmut cohort and non-gBRCAmut cohort.
- param Type
- Hazard Ratio (HR)
- param Value
- 0.27
- statistical Comment
- Strata: tm to progression after penultimate platinum tx; use of bevacizumab w/penultimate or last platinum tx; best response during last platinum tx.
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.173
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.410
- estimate Comment
- Niraparib:Placebo, based on the stratified Cox Proportional Hazards Model using randomization stratification factors.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- <0.0001
- p Value Comment
- Two-sided P-value. PFS was independently evaluated in gBRCAmut cohort and non-gBRCAmut cohort.
- param Type
- Hazard Ratio (HR)
- param Value
- 0.27
- statistical Comment
- Strata: tm to progression after penultimate platinum tx; use of bevacizumab w/penultimate or last platinum tx; best response during last platinum tx.
- statistical Method
- Log Rank
- classes
- categories
- measurements
- comment
- Upper limit of confidence interval (CI) was not estimable as upper limits of CI for survivor function were above 0.5 (SAS PROC LIFETEST).
- group Id
- OG000
- lower Limit
- 12.9
- upper Limit
- NA
- value
- 21
- group Id
- OG001
- lower Limit
- 3.8
- upper Limit
- 7.2
- value
- 5.5
- denoms
- counts
- group Id
- OG000
- value
- 138
- group Id
- OG001
- value
- 65
- units
- Participants
- description
- PFS was defined as the time between randomization and disease progression or death from any cause. Computed tomography or magnetic resonance imaging to assess disease progression was performed at baseline, every 8 weeks through cycle 14, and then every 12 weeks until treatment discontinuation. The objective assessment of disease progression was determined by means of central radiologic and clinical review, according to Response Evaluation Criteria in Solid Tumors (RECIST),version 1.1, which was performed in a blinded fashion. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants with germline breast cancer gene (gBRCA) mutation received oral dose of niraparib 300 milligrams (mg) once daily in 28-day cycles until disease progression.
- id
- OG000
- title
- gBRCA Niraparib
- description
- Participants with germline BRCA mutation received oral dose of placebo matching niraparib once daily in 28-day cycles until disease progression.
- id
- OG001
- title
- gBRCA Placebo
- param Type
- MEDIAN
- population Description
- Intent-to-treat population was defined as all randomized participants with participants analyzed according to the study drug assigned via randomization
- reporting Status
- POSTED
- time Frame
- From date of randomization to the earliest date of disease progression or death from any cause, up to 7 years 7 months and 4 days
- title
- Progression-Free Survival (PFS) in Cohort With Germline BReast CAncer Gene (BRCA) Mutation (gBRCA)
- type
- PRIMARY
- unit Of Measure
- months
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Preserved source evidence · Not medical advice