TriangleNCT05654623 · OUTCOME
PFS by BICR Assessment Per RECIST v1.1-Participants With ESR1 Mutation
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 date of first documentation of objective PD or death (any cause) or censoring date, whichever occurred first (up to 18.56 months and 19.38 months of treatment exposure for vepdegestrant and fulvestrant arms respectively)
What was measured
PFS assessed by BICR was defined as the time from the date of randomization to the date of the first documentation of objective PD per RECIST v1.1, or death due to any cause, whichever occurred first. PD as per RECIST v1.1 was defined as at least a 20% increase in the sum of diameters of target measurable lesions above nadir (smallest sum observed considering baseline and all assessments prior to the timepoint under evaluation), with a minimum absolute increase of 5 mm relative to nadir or unequivocal progression of existing non-target lesions or the presence of new lesions. PFS was censored on the date of last adequate disease assessment for those who did not have a PFS event, discontinued the study treatment due to withdrawal of consent prior to an event, started a new anticancer therapy prior to an event, had an event after a gap of 2 or more missing disease assessments, or lost to follow-up. Kaplan-Meier method was used.
Analysis population: FAS included all enrolled participants who were randomized. Here, "Overall Number of Participants Analyzed" signifies participants with known ESR1 mutation-positive breast cancer.
Groups in this outcome
Vepdegestrant
Participants were randomized to receive vepdegestrant 200 mg orally, once daily on Days 1 to 28 of each 28-day cycle. Participants continued to receive assigned treatment until objective disease progression, unacceptable toxicity, death, participant refused further treatment, or one of the other reasons for treatment discontinuation per protocol was met.
Fulvestrant
Participants were randomized to receive fulvestrant 500 mg, intramuscularly (injection) on Days 1 and 15 of Cycle 1 and then on Day 1 of each cycle starting from Cycle 2 Day 1, where 1 cycle = 28 days. Participants continued to receive assigned treatment until objective disease progression, unacceptable toxicity, death, participant refused further treatment, or one of the other reasons for treatment discontinuation per protocol was met.
| Group | Source count |
|---|---|
| Vepdegestrant | 136 |
| Fulvestrant | 134 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Vepdegestrant | 5.0 | Not reported | 3.7 | 7.4 | Not reported |
| Fulvestrant | 2.1 | Not reported | 1.9 | 3.5 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.418
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.770
- estimate Comment
- HR was calculated based on Cox's Proportional Hazard model.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0001
- param Type
- Hazard Ratio (HR)
- param Value
- 0.57
- statistical Comment
- 1-sided P-value based on log-rank test.
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.418
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.770
- estimate Comment
- HR was calculated based on Cox's Proportional Hazard model.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0001
- param Type
- Hazard Ratio (HR)
- param Value
- 0.57
- statistical Comment
- 1-sided P-value based on log-rank test.
- statistical Method
- Log Rank
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 3.7
- upper Limit
- 7.4
- value
- 5.0
- group Id
- OG001
- lower Limit
- 1.9
- upper Limit
- 3.5
- value
- 2.1
- denoms
- counts
- group Id
- OG000
- value
- 136
- group Id
- OG001
- value
- 134
- units
- Participants
- description
- PFS assessed by BICR was defined as the time from the date of randomization to the date of the first documentation of objective PD per RECIST v1.1, or death due to any cause, whichever occurred first. PD as per RECIST v1.1 was defined as at least a 20% increase in the sum of diameters of target measurable lesions above nadir (smallest sum observed considering baseline and all assessments prior to the timepoint under evaluation), with a minimum absolute increase of 5 mm relative to nadir or unequivocal progression of existing non-target lesions or the presence of new lesions. PFS was censored on the date of last adequate disease assessment for those who did not have a PFS event, discontinued the study treatment due to withdrawal of consent prior to an event, started a new anticancer therapy prior to an event, had an event after a gap of 2 or more missing disease assessments, or lost to follow-up. Kaplan-Meier method was used.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants were randomized to receive vepdegestrant 200 mg orally, once daily on Days 1 to 28 of each 28-day cycle. Participants continued to receive assigned treatment until objective disease progression, unacceptable toxicity, death, participant refused further treatment, or one of the other reasons for treatment discontinuation per protocol was met.
- id
- OG000
- title
- Vepdegestrant
- description
- Participants were randomized to receive fulvestrant 500 mg, intramuscularly (injection) on Days 1 and 15 of Cycle 1 and then on Day 1 of each cycle starting from Cycle 2 Day 1, where 1 cycle = 28 days. Participants continued to receive assigned treatment until objective disease progression, unacceptable toxicity, death, participant refused further treatment, or one of the other reasons for treatment discontinuation per protocol was met.
- id
- OG001
- title
- Fulvestrant
- param Type
- MEDIAN
- population Description
- FAS included all enrolled participants who were randomized. Here, "Overall Number of Participants Analyzed" signifies participants with known ESR1 mutation-positive breast cancer.
- reporting Status
- POSTED
- time Frame
- From date of randomization to date of first documentation of objective PD or death (any cause) or censoring date, whichever occurred first (up to 18.56 months and 19.38 months of treatment exposure for vepdegestrant and fulvestrant arms respectively)
- title
- PFS by BICR Assessment Per RECIST v1.1-Participants With ESR1 Mutation
- type
- PRIMARY
- unit Of Measure
- Months
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Preserved source evidence · Not medical advice