TriangleNCT02513394 · OUTCOME
Distant Recurrence-free Survival (DRFS)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage of patients
- Interval / dispersion
- Not reported
- Time frame
- 4 years
What was measured
Compare time to distant recurrence-free survival (DRFS). Distant recurrence is defined according to STEEP criteria as the time from randomization to the date of the first event: distant recurrence or death from any cause. Patients with a locoregional recurrence will continue to be followed for DRFS. Surviving patients who are event-free will be censored at: the date of last disease assessment, or withdrawal of consent to be followed, or death whichever came first. Direct comparison between arms used time to DRFS events and Kaplan-Meier Log-rank analysis. Due to the medians not yet achieved, the percentage of patients considered DRFS at 4 years is reported.
Groups in this outcome
Palbociclib Plus Endocrine Therapy (Arm A)
Palbociclib at a dose of 125 mg orally once daily, Day 1 to Day 21 followed by 7 days off treatment in a 28-day cycle for a total duration of 2 years, in addition to standard adjuvant endocrine therapy for a duration of at least 5 years.
Endocrine Therapy Alone (Arm B)
Standard adjuvant endocrine therapy for a duration of at least 5 years.
| Group | Source count |
|---|---|
| Palbociclib Plus Endocrine Therapy (Arm A) | 2884 |
| Endocrine Therapy Alone (Arm B) | 2877 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Palbociclib Plus Endocrine Therapy (Arm A) | 86.2 | Not reported | Not reported | Not reported | Not reported |
| Endocrine Therapy Alone (Arm B) | 87.8 | Not reported | Not reported | Not reported | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.87
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.28
- group Ids
- OG000
- OG001
- non Inferiority Type
- OTHER
- param Type
- Hazard Ratio (HR)
- param Value
- 1.05
Complete source fields
- analyses
- ci Lower Limit
- 0.87
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.28
- group Ids
- OG000
- OG001
- non Inferiority Type
- OTHER
- param Type
- Hazard Ratio (HR)
- param Value
- 1.05
- classes
- categories
- measurements
- group Id
- OG000
- value
- 86.2
- group Id
- OG001
- value
- 87.8
- denoms
- counts
- group Id
- OG000
- value
- 2884
- group Id
- OG001
- value
- 2877
- units
- Participants
- description
- Compare time to distant recurrence-free survival (DRFS). Distant recurrence is defined according to STEEP criteria as the time from randomization to the date of the first event: distant recurrence or death from any cause. Patients with a locoregional recurrence will continue to be followed for DRFS. Surviving patients who are event-free will be censored at: the date of last disease assessment, or withdrawal of consent to be followed, or death whichever came first. Direct comparison between arms used time to DRFS events and Kaplan-Meier Log-rank analysis. Due to the medians not yet achieved, the percentage of patients considered DRFS at 4 years is reported.
- groups
- description
- Palbociclib at a dose of 125 mg orally once daily, Day 1 to Day 21 followed by 7 days off treatment in a 28-day cycle for a total duration of 2 years, in addition to standard adjuvant endocrine therapy for a duration of at least 5 years.
- id
- OG000
- title
- Palbociclib Plus Endocrine Therapy (Arm A)
- description
- Standard adjuvant endocrine therapy for a duration of at least 5 years.
- id
- OG001
- title
- Endocrine Therapy Alone (Arm B)
- param Type
- NUMBER
- reporting Status
- POSTED
- time Frame
- 4 years
- title
- Distant Recurrence-free Survival (DRFS)
- type
- SECONDARY
- unit Of Measure
- percentage of patients
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice