TriangleNCT04305496 · OUTCOME
Progression Free Survival: Overall Population (Months) in the Global Cohort
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
- Assessed every 8 weeks for the first 18 months and every 12 weeks thereafter, from randomization to radiological progression.
What was measured
Progression free survival (PFS), defined as the time from randomization until progression per RECIST v1.1, as assessed by the investigator at the local site, or death due to any cause, in the global cohort. Participants who discontinue treatment prior to progression should continue to be scanned until progression. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) as at least a 20% increase in the sum of the longest diameter of target lesions (short axis diameter used for lymph nodes), or clinically significant increase in a non-target lesion, or the appearance of a new lesion(s).
Analysis population: Overall population in the global cohort
Groups in this outcome
Capivasertib + Fulvestrant (Global + China Cohort)
Capivasertib: 400 mg twice daily (2 tablets of 200 mg taken orally twice daily; total daily dose 800 mg) given on an intermittent weekly dosing schedule (4 days on/3 days off). Fulvestrant: 500 mg (2 intramuscular injections of 250 mg/5 mL solution) on Day 1 of Weeks 1 and 3 of Cycle 1, and then on Day 1, Week 1 of each cycle thereafter.
Placebo + Fulvestrant (Global + China Cohort)
Placebo: Placebo tablets matching capivasertib. 400 mg twice daily (2 tablets of 200 mg taken orally twice daily; total daily dose 800 mg) given on an intermittent weekly dosing schedule (4 days on/3 days off). Fulvestrant: 500 mg (2 intramuscular injections of 250 mg/5 mL solution) on Day 1 of Weeks 1 and 3 of Cycle 1, and then on Day 1, Week 1 of each cycle thereafter.
| Group | Source count |
|---|---|
| Capivasertib + Fulvestrant (Global + China Cohort) | 355 |
| Placebo + Fulvestrant (Global + China Cohort) | 353 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Capivasertib + Fulvestrant (Global + China Cohort) | 7.2 | Not reported | 5.5 | 7.4 | Not reported |
| Placebo + Fulvestrant (Global + China Cohort) | 3.6 | Not reported | 2.8 | 3.7 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.51
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.71
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- <0.001
- param Type
- Hazard Ratio (HR)
- param Value
- 0.60
- statistical Method
- Stratified log rank test
Complete source fields
- analyses
- ci Lower Limit
- 0.51
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.71
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- <0.001
- param Type
- Hazard Ratio (HR)
- param Value
- 0.60
- statistical Method
- Stratified log rank test
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 5.5
- upper Limit
- 7.4
- value
- 7.2
- group Id
- OG001
- lower Limit
- 2.8
- upper Limit
- 3.7
- value
- 3.6
- denoms
- counts
- group Id
- OG000
- value
- 355
- group Id
- OG001
- value
- 353
- units
- Participants
- description
- Progression free survival (PFS), defined as the time from randomization until progression per RECIST v1.1, as assessed by the investigator at the local site, or death due to any cause, in the global cohort. Participants who discontinue treatment prior to progression should continue to be scanned until progression. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) as at least a 20% increase in the sum of the longest diameter of target lesions (short axis diameter used for lymph nodes), or clinically significant increase in a non-target lesion, or the appearance of a new lesion(s).
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Capivasertib: 400 mg twice daily (2 tablets of 200 mg taken orally twice daily; total daily dose 800 mg) given on an intermittent weekly dosing schedule (4 days on/3 days off). Fulvestrant: 500 mg (2 intramuscular injections of 250 mg/5 mL solution) on Day 1 of Weeks 1 and 3 of Cycle 1, and then on Day 1, Week 1 of each cycle thereafter.
- id
- OG000
- title
- Capivasertib + Fulvestrant (Global + China Cohort)
- description
- Placebo: Placebo tablets matching capivasertib. 400 mg twice daily (2 tablets of 200 mg taken orally twice daily; total daily dose 800 mg) given on an intermittent weekly dosing schedule (4 days on/3 days off). Fulvestrant: 500 mg (2 intramuscular injections of 250 mg/5 mL solution) on Day 1 of Weeks 1 and 3 of Cycle 1, and then on Day 1, Week 1 of each cycle thereafter.
- id
- OG001
- title
- Placebo + Fulvestrant (Global + China Cohort)
- param Type
- MEDIAN
- population Description
- Overall population in the global cohort
- reporting Status
- POSTED
- time Frame
- Assessed every 8 weeks for the first 18 months and every 12 weeks thereafter, from randomization to radiological progression.
- title
- Progression Free Survival: Overall Population (Months) in the Global Cohort
- type
- PRIMARY
- unit Of Measure
- Months
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Preserved source evidence · Not medical advice