TriangleNCT04191499 · 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
- Up to 3.7 years
What was measured
PFS was defined as the time from randomization to the first occurrence of disease progression, as determined by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1 or death from any cause (whichever occurs first). Progressive disease (PD) was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum in the study, including baseline, in addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeter (mm). The appearance of one or more new lesions was also considered progression. Data for participants without the occurrence of PD or death as of the clinical cutoff date (CCOD) were censored at the time of the last tumor assessment prior to the CCOD. Median PFS was calculated using the Kaplan-Meier methodology.
Analysis population: FAS included all participants who were randomized to receive the treatment they were assigned.
Groups in this outcome
Inavo+Palbo+Fulv
Participants received inavolisib, 9 mg, orally, QD on Days 1-28 of each 28 day cycle along with palbociclib 125 mg, orally, QD on Days 1-21 and fulvestrant, 500 mg, IM injections on Days 1 and 15 of Cycle 1 and then on Day 1 of each subsequent 28 day cycle until unequivocal disease progression, unacceptable toxicity, participant withdrawal of consent, or study termination.
Pbo+Palbo+Fulv
Participants received placebo, orally, QD on Days 1-28 of each 28 day cycle along with palbociclib 125 mg, orally, QD on Days 1-21 and fulvestrant, 500 mg, IM injections on Days 1 and 15 of Cycle 1 and then of Day 1 of each subsequent 28 day cycle until unequivocal disease progression, unacceptable toxicity, participant withdrawal of consent, or study termination.
| Group | Source count |
|---|---|
| Inavo+Palbo+Fulv | 161 |
| Pbo+Palbo+Fulv | 164 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Inavo+Palbo+Fulv | 15 | Not reported | 11.3 | 20.5 | Not reported |
| Pbo+Palbo+Fulv | 7.3 | Not reported | 5.6 | 9.3 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.32
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.59
- group Description
- Hazard ratios were estimated by Cox regression. Hazard ratios and log-rank p-values are using stratified methods by stratifying Visceral Disease, Endocrine Resistance, and Region.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- <0.0001
- param Type
- Hazard Ratio (HR)
- param Value
- 0.43
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.32
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.59
- group Description
- Hazard ratios were estimated by Cox regression. Hazard ratios and log-rank p-values are using stratified methods by stratifying Visceral Disease, Endocrine Resistance, and Region.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- <0.0001
- param Type
- Hazard Ratio (HR)
- param Value
- 0.43
- statistical Method
- Log Rank
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 11.3
- upper Limit
- 20.5
- value
- 15
- group Id
- OG001
- lower Limit
- 5.6
- upper Limit
- 9.3
- value
- 7.3
- denoms
- counts
- group Id
- OG000
- value
- 161
- group Id
- OG001
- value
- 164
- units
- Participants
- description
- PFS was defined as the time from randomization to the first occurrence of disease progression, as determined by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1 or death from any cause (whichever occurs first). Progressive disease (PD) was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum in the study, including baseline, in addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeter (mm). The appearance of one or more new lesions was also considered progression. Data for participants without the occurrence of PD or death as of the clinical cutoff date (CCOD) were censored at the time of the last tumor assessment prior to the CCOD. Median PFS was calculated using the Kaplan-Meier methodology.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received inavolisib, 9 mg, orally, QD on Days 1-28 of each 28 day cycle along with palbociclib 125 mg, orally, QD on Days 1-21 and fulvestrant, 500 mg, IM injections on Days 1 and 15 of Cycle 1 and then on Day 1 of each subsequent 28 day cycle until unequivocal disease progression, unacceptable toxicity, participant withdrawal of consent, or study termination.
- id
- OG000
- title
- Inavo+Palbo+Fulv
- description
- Participants received placebo, orally, QD on Days 1-28 of each 28 day cycle along with palbociclib 125 mg, orally, QD on Days 1-21 and fulvestrant, 500 mg, IM injections on Days 1 and 15 of Cycle 1 and then of Day 1 of each subsequent 28 day cycle until unequivocal disease progression, unacceptable toxicity, participant withdrawal of consent, or study termination.
- id
- OG001
- title
- Pbo+Palbo+Fulv
- param Type
- MEDIAN
- population Description
- FAS included all participants who were randomized to receive the treatment they were assigned.
- reporting Status
- POSTED
- time Frame
- Up to 3.7 years
- title
- Progression-Free Survival (PFS)
- type
- PRIMARY
- unit Of Measure
- months
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Preserved source evidence · Not medical advice