TriangleNCT01740427 · OUTCOME
Objective Response as Assessed by the Investigator
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Percentage of participants
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- From randomization until end of treatment (up to approximately 2.5 years)
What was measured
Objective Response (OR) defined as overall complete response (CR) or partial response (PR) according to RECIST v1.1. Objective Response Rate (ORR) is defined as proportion of participants with CR or PR relative to all randomized participants with measurable disease at baseline. Participants who do not have on-study radiographic tumor re-evaluation, who received anti-tumor treatment, or who died, progressed/ dropped out for any reason prior to reaching a CR or PR were counted as non-responders in assessment of ORR. Per RECIST v1.1, CR: Complete disappearance of target lesions with exception of nodal disease. All target nodes must decrease to normal size (short axis \<10mm). PR: \>=30% decrease under baseline of the sum of diameters of all target measurable lesions. The short diameter is used in the sum for target nodes, while the longest diameter is used in the sum for all other target lesions. Stable Disease: neither sufficient shrinkage nor increase to qualify for disease progression.
Analysis population: ITT population or full analysis set included all participants who were randomized, with study medication, regardless of whether participants received study medication or received a different drug from that to which they were randomized.
Groups in this outcome
Palbociclib Plus Letrozole
Participants received letrozole 2.5 milligram (mg) orally QD (once daily) combined with palbociclib 125 mg QD for 21 days of every-28-day cycle, followed by 7 days off treatment.
Placebo Plus Letrozole
Participants received letrozole 2.5 mg orally QD combined with placebo QD for 21 days of every-28-day cycle, followed by 7 days off treatment.
| Group | Source count |
|---|---|
| Palbociclib Plus Letrozole | 444 |
| Placebo Plus Letrozole | 222 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Palbociclib Plus Letrozole | 46.4 | Not reported | 41.7 | 51.2 | Not reported |
| Placebo Plus Letrozole | 38.3 | Not reported | 31.9 | 45.0 | Not reported |
Source statistical analyses
- ci Lower Limit
- 1.008
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 2.030
- group Description
- Stratified analysis: Stratified by disease site (visceral vs non-visceral) per randomization.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- p Value
- 0.0224
- p Value Comment
- 1-sided p-value is from exact test.
- param Type
- Odds Ratio (OR)
- param Value
- 1.428
- statistical Method
- Fisher Exact
Complete source fields
- analyses
- ci Lower Limit
- 1.008
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 2.030
- group Description
- Stratified analysis: Stratified by disease site (visceral vs non-visceral) per randomization.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- p Value
- 0.0224
- p Value Comment
- 1-sided p-value is from exact test.
- param Type
- Odds Ratio (OR)
- param Value
- 1.428
- statistical Method
- Fisher Exact
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 41.7
- upper Limit
- 51.2
- value
- 46.4
- group Id
- OG001
- lower Limit
- 31.9
- upper Limit
- 45.0
- value
- 38.3
- denoms
- counts
- group Id
- OG000
- value
- 444
- group Id
- OG001
- value
- 222
- units
- Participants
- description
- Objective Response (OR) defined as overall complete response (CR) or partial response (PR) according to RECIST v1.1. Objective Response Rate (ORR) is defined as proportion of participants with CR or PR relative to all randomized participants with measurable disease at baseline. Participants who do not have on-study radiographic tumor re-evaluation, who received anti-tumor treatment, or who died, progressed/ dropped out for any reason prior to reaching a CR or PR were counted as non-responders in assessment of ORR. Per RECIST v1.1, CR: Complete disappearance of target lesions with exception of nodal disease. All target nodes must decrease to normal size (short axis \<10mm). PR: \>=30% decrease under baseline of the sum of diameters of all target measurable lesions. The short diameter is used in the sum for target nodes, while the longest diameter is used in the sum for all other target lesions. Stable Disease: neither sufficient shrinkage nor increase to qualify for disease progression.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received letrozole 2.5 milligram (mg) orally QD (once daily) combined with palbociclib 125 mg QD for 21 days of every-28-day cycle, followed by 7 days off treatment.
- id
- OG000
- title
- Palbociclib Plus Letrozole
- description
- Participants received letrozole 2.5 mg orally QD combined with placebo QD for 21 days of every-28-day cycle, followed by 7 days off treatment.
- id
- OG001
- title
- Placebo Plus Letrozole
- param Type
- NUMBER
- population Description
- ITT population or full analysis set included all participants who were randomized, with study medication, regardless of whether participants received study medication or received a different drug from that to which they were randomized.
- reporting Status
- POSTED
- time Frame
- From randomization until end of treatment (up to approximately 2.5 years)
- title
- Objective Response as Assessed by the Investigator
- type
- SECONDARY
- unit Of Measure
- Percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice