TriangleNCT01740427 · OUTCOME
Progression-Free Survival (PFS) as Assessed by the Investigator
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 randomization date to date of first documentation of progression or death (up to approximately 2.5 years)
What was measured
PFS is defined as the time from the date of randomization to the date of the first documentation of objective tumor progression as per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) or death due to any cause in the absence of documented PD, whichever occurs first. If tumor progression data include more than 1 date, the first date will be used. PFS (in months) will be calculated as (first event date - randomization date +1)/30.4. Progression is defined using RECIST v1.1, as a 20% increase in the sum of diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum is observed during therapy), with a minimum absolute increase of 5 mm, or unequivocal progression of pre-existing non-target lesions, or the appearance of new lesions.
Analysis population: ITT population or full analysis set included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study medication or received a different drug from that to which they were randomized.
Groups in this outcome
Palbociclib Plus Letrozole
Participants received letrozole 2.5 milligram (mg) orally QD (once daily) combined with palbociclib 125 mg QD for 21 days of every-28-day cycle, followed by 7 days off treatment.
Placebo Plus Letrozole
Participants received letrozole 2.5 mg orally QD combined with placebo QD for 21 days of every-28-day cycle, followed by 7 days off treatment.
| Group | Source count |
|---|---|
| Palbociclib Plus Letrozole | 444 |
| Placebo Plus Letrozole | 222 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Palbociclib Plus Letrozole | 24.8 | Not reported | 22.1 | NA | The value was not available because there was not enough disease progression events in the treatment group at the time of analysis, due to drug benefit. |
| Placebo Plus Letrozole | 14.5 | Not reported | 12.9 | 17.1 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.463
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.718
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- p Value
- <0.000001
- p Value Comment
- 1-sided p-value from the stratified log-rank test.
- param Type
- Hazard Ratio (HR)
- param Value
- 0.576
- statistical Method
- Stratified Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.463
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.718
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- p Value
- <0.000001
- p Value Comment
- 1-sided p-value from the stratified log-rank test.
- param Type
- Hazard Ratio (HR)
- param Value
- 0.576
- statistical Method
- Stratified Log Rank
- classes
- categories
- measurements
- comment
- The value was not available because there was not enough disease progression events in the treatment group at the time of analysis, due to drug benefit.
- group Id
- OG000
- lower Limit
- 22.1
- upper Limit
- NA
- value
- 24.8
- group Id
- OG001
- lower Limit
- 12.9
- upper Limit
- 17.1
- value
- 14.5
- denoms
- counts
- group Id
- OG000
- value
- 444
- group Id
- OG001
- value
- 222
- units
- Participants
- description
- PFS is defined as the time from the date of randomization to the date of the first documentation of objective tumor progression as per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) or death due to any cause in the absence of documented PD, whichever occurs first. If tumor progression data include more than 1 date, the first date will be used. PFS (in months) will be calculated as (first event date - randomization date +1)/30.4. Progression is defined using RECIST v1.1, as a 20% increase in the sum of diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum is observed during therapy), with a minimum absolute increase of 5 mm, or unequivocal progression of pre-existing non-target lesions, or the appearance of new lesions.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received letrozole 2.5 milligram (mg) orally QD (once daily) combined with palbociclib 125 mg QD for 21 days of every-28-day cycle, followed by 7 days off treatment.
- id
- OG000
- title
- Palbociclib Plus Letrozole
- description
- Participants received letrozole 2.5 mg orally QD combined with placebo QD for 21 days of every-28-day cycle, followed by 7 days off treatment.
- id
- OG001
- title
- Placebo Plus Letrozole
- param Type
- MEDIAN
- population Description
- ITT population or full analysis set included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study medication or received a different drug from that to which they were randomized.
- reporting Status
- POSTED
- time Frame
- From randomization date to date of first documentation of progression or death (up to approximately 2.5 years)
- title
- Progression-Free Survival (PFS) as Assessed by the Investigator
- type
- PRIMARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice