TriangleNCT05169567 · OUTCOME
Progression-Free Survival (PFS)
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
- Randomization to the date of first documented progression of disease or death from any cause (Up to 21 Months)
What was measured
PFS defined as the time from the date of randomization to the first evidence of disease progression as defined by response evaluation criteria in solid tumors (RECIST) v1.1 or death from any cause. Progressive Disease (PD) was at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. If a participant does not have a complete baseline disease assessment, then the PFS time was censored at the date of randomization, regardless of whether or not objectively determined disease progression or death has been observed for the participant. If a participant was not known to have died or have objective progression as of the data inclusion cutoff date for the analysis, the PFS time was censored at the last adequate tumor assessment date.
Analysis population: All randomized participants (including censored). Censored participants: Abemaciclib plus fulvestrant (n = 65), Placebo plus fulvestrant (n = 45).
Groups in this outcome
Arm A: Abemaciclib Plus Fulvestrant
Abemaciclib 150 mg administered orally BID on Days 1 to 28 of a 28-day cycle in combination with fulvestrant 500 mg administered IM on Days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond. Participants received treatment until discontinuation criteria were met.
Arm B: Placebo Plus Fulvestrant
Placebo administered orally BID on Days 1 to 28 of a 28-day cycle in combination with fulvestrant 500 mg administered IM on Days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond. Participants received treatment until discontinuation criteria were met.
| Group | Source count |
|---|---|
| Arm A: Abemaciclib Plus Fulvestrant | 182 |
| Arm B: Placebo Plus Fulvestrant | 186 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm A: Abemaciclib Plus Fulvestrant | 6 | Not reported | 5.6 | 8.1 | Not reported |
| Arm B: Placebo Plus Fulvestrant | 5.3 | Not reported | 3.7 | 5.6 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.57
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.95
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.02
- param Type
- Hazard Ratio (HR)
- param Value
- 0.73
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.57
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.95
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.02
- param Type
- Hazard Ratio (HR)
- param Value
- 0.73
- statistical Method
- Log Rank
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 5.6
- upper Limit
- 8.1
- value
- 6
- group Id
- OG001
- lower Limit
- 3.7
- upper Limit
- 5.6
- value
- 5.3
- denoms
- counts
- group Id
- OG000
- value
- 182
- group Id
- OG001
- value
- 186
- units
- Participants
- description
- PFS defined as the time from the date of randomization to the first evidence of disease progression as defined by response evaluation criteria in solid tumors (RECIST) v1.1 or death from any cause. Progressive Disease (PD) was at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. If a participant does not have a complete baseline disease assessment, then the PFS time was censored at the date of randomization, regardless of whether or not objectively determined disease progression or death has been observed for the participant. If a participant was not known to have died or have objective progression as of the data inclusion cutoff date for the analysis, the PFS time was censored at the last adequate tumor assessment date.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Abemaciclib 150 mg administered orally BID on Days 1 to 28 of a 28-day cycle in combination with fulvestrant 500 mg administered IM on Days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond. Participants received treatment until discontinuation criteria were met.
- id
- OG000
- title
- Arm A: Abemaciclib Plus Fulvestrant
- description
- Placebo administered orally BID on Days 1 to 28 of a 28-day cycle in combination with fulvestrant 500 mg administered IM on Days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond. Participants received treatment until discontinuation criteria were met.
- id
- OG001
- title
- Arm B: Placebo Plus Fulvestrant
- param Type
- MEDIAN
- population Description
- All randomized participants (including censored). Censored participants: Abemaciclib plus fulvestrant (n = 65), Placebo plus fulvestrant (n = 45).
- reporting Status
- POSTED
- time Frame
- Randomization to the date of first documented progression of disease or death from any cause (Up to 21 Months)
- title
- Progression-Free Survival (PFS)
- type
- PRIMARY
- unit Of Measure
- Months
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Preserved source evidence · Not medical advice