TriangleNCT00553410 · OUTCOME
Distant Recurrence-free Interval (DRFI)
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
- 95% Confidence Interval
- Time frame
- 5-year estimates, reported at a median follow-up of 60 months
What was measured
Duration of time from randomization to the first indication of invasive breast recurrence at a distant site. In the absence of an event, DRFI was censored at the date of last follow-up visit or date or death without distant recurrence.\* \*This endpoint replaced DDFS, which was specified in the protocol
Analysis population: Intention-to-treat
Groups in this outcome
Arm A: Continuous Letrozole
Continuous letrozole: 5 years continuously (2.5 mg Letrozole daily) Letrozole: Film-coated tablet, oral use, 2.5 mg Letrozole daily for 5 years continuously
Arm B: Intermittent Letrozole
Intermittent letrozole: 48 months over 5 yrs: 4 x 9 months (9 mo followed by 3 mo treatment-free interval in yrs 1-4, -\> 36 mo) plus 1 x 12 mo in yr 5 -\> 48 months Letrozole: Film-coated tablet, oral use, 2.5 mg daily, 48 months over 5 yrs: 4 x 9 months (9 mo followed by 3 mo treatment-free interval in yrs 1-4, -\> 36 mo) plus 1 x 12 mo in yr 5 -\> 48 months
| Group | Source count |
|---|---|
| Arm A: Continuous Letrozole | 2426 |
| Arm B: Intermittent Letrozole | 2425 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm A: Continuous Letrozole | 92.5 | Not reported | 91.3 | 93.5 | Not reported |
| Arm B: Intermittent Letrozole | 93.2 | Not reported | 92 | 94.2 | Not reported |
Source statistical analyses
- ci Lower Limit
- .71
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.09
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- .25
- param Type
- Hazard Ratio (HR)
- param Value
- .88
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- .71
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.09
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- .25
- param Type
- Hazard Ratio (HR)
- param Value
- .88
- statistical Method
- Log Rank
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 91.3
- upper Limit
- 93.5
- value
- 92.5
- group Id
- OG001
- lower Limit
- 92
- upper Limit
- 94.2
- value
- 93.2
- denoms
- counts
- group Id
- OG000
- value
- 2426
- group Id
- OG001
- value
- 2425
- units
- Participants
- description
- Duration of time from randomization to the first indication of invasive breast recurrence at a distant site. In the absence of an event, DRFI was censored at the date of last follow-up visit or date or death without distant recurrence.\* \*This endpoint replaced DDFS, which was specified in the protocol
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Continuous letrozole: 5 years continuously (2.5 mg Letrozole daily) Letrozole: Film-coated tablet, oral use, 2.5 mg Letrozole daily for 5 years continuously
- id
- OG000
- title
- Arm A: Continuous Letrozole
- description
- Intermittent letrozole: 48 months over 5 yrs: 4 x 9 months (9 mo followed by 3 mo treatment-free interval in yrs 1-4, -\> 36 mo) plus 1 x 12 mo in yr 5 -\> 48 months Letrozole: Film-coated tablet, oral use, 2.5 mg daily, 48 months over 5 yrs: 4 x 9 months (9 mo followed by 3 mo treatment-free interval in yrs 1-4, -\> 36 mo) plus 1 x 12 mo in yr 5 -\> 48 months
- id
- OG001
- title
- Arm B: Intermittent Letrozole
- param Type
- NUMBER
- population Description
- Intention-to-treat
- reporting Status
- POSTED
- time Frame
- 5-year estimates, reported at a median follow-up of 60 months
- title
- Distant Recurrence-free Interval (DRFI)
- type
- SECONDARY
- unit Of Measure
- percentage of patients
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice