TriangleNCT00567190 · OUTCOME
Progression-Free Survival (PFS) Determined by an Independent Review Facility
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
- Tumor assessments every 9 weeks from randomization to IRF-determined PD or death from any cause, whichever occurred first, up to the primary completion date (up to 3 years, 3 months)
What was measured
PFS was defined as the time from randomization to first documented radiographical progressive disease (PD), as determined by an independent review facility (IRF) using RECIST version 1.0, or death from any cause (within 18 weeks of last tumor assessment), whichever occurred first (Kaplan-Meier method). For target lesions, PD was defined as at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum of the LD recorded since treatment started or the appearance of ≥1 new lesion. For non-target lesions, PD was defined as the appearance of ≥1 new lesion or unequivocal progression of existing lesions. Participants without IRF-determined PD or who had not died within 18 weeks of their last IRF-determined, progression-free tumor assessment were censored at the date of the last IRF-reviewed, evaluable tumor assessment; those with no post-baseline tumor assessment and who had not died within 18 weeks of baseline were censored at 1 day.
Analysis population: Intent-to-Treat (ITT) Population: All randomized participants
Groups in this outcome
Pertuzumab + Trastuzumab + Docetaxel
Participants randomized to this arm received pertuzumab 420 milligrams (mg) intravenously (IV) once every 3 weeks (q3w) and trastuzumab 6 milligrams per kilogram (mg/kg) IV q3w, plus docetaxel 75 milligrams per square metre of body surface (mg/m\^2) IV q3w (for at least 6 cycles; 1 cycle was 21 days). After Cycle 6, continuation of docetaxel treatment was at the discretion of the participant and treating physician. Participants remained in the treatment phase of the study until investigator-assessed radiographic or clinical evidence of disease progression, unmanageable toxicity, or study termination and were followed for survival until death, loss to follow-up, withdrawal of consent, or study termination.
Placebo + Trastuzumab + Docetaxel
Participants randomized to this arm received placebo IV q3w and trastuzumab 6 mg/kg IV q3w, plus docetaxel 75 mg/m\^2 IV q3w (for at least 6 cycles; 1 cycle was 21 days). After Cycle 6, continuation of docetaxel treatment was at the discretion of the participant and treating physician. Participants remained in the treatment phase of the study until investigator-assessed radiographic or clinical evidence of disease progression, unmanageable toxicity, or study termination and were followed for survival until death, loss to follow-up, withdrawal of consent, or study termination.
| Group | Source count |
|---|---|
| Pertuzumab + Trastuzumab + Docetaxel | 402 |
| Placebo + Trastuzumab + Docetaxel | 406 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Pertuzumab + Trastuzumab + Docetaxel | 18.5 | Not reported | 15 | 23 | Not reported |
| Placebo + Trastuzumab + Docetaxel | 12.4 | Not reported | 10 | 13 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.51
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.75
- estimate Comment
- Hazard ratio is comparing Pertuzumab arm with Placebo arm.
- group Description
- The null hypothesis (H0) was that the survival distributions of PFS in the two treatments arms (pertuzumab vs. placebo) are the same. The alternative hypothesis (H1) was that the survival distribution of PFS in the experimental arm (pertuzumab) and control arm (placebo) are different.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- <0.0001
- p Value Comment
- Tested at two-sided 5% significance level
- param Type
- Cox Proportional Hazard
- param Value
- 0.62
- statistical Comment
- Stratified by prior treatment status and region
- statistical Method
- Log Rank (stratified)
- ci Lower Limit
- 0.52
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.76
- estimate Comment
- Hazard ratio is comparing Pertuzumab arm with Placebo arm.
- group Description
- The null hypothesis (H0) was that the survival distributions of PFS in the two treatments arms (pertuzumab vs. placebo) are the same. The alternative hypothesis (H1) was that the survival distribution of PFS in the experimental arm (pertuzumab) and control arm (placebo) are different.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- <0.0001
- p Value Comment
- Tested at two-sided 5% significance level
- param Type
- Cox Proportional Hazard
- param Value
- 0.63
- statistical Comment
- Unstratified
- statistical Method
- Log Rank (unstratified)
Complete source fields
- analyses
- ci Lower Limit
- 0.51
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.75
- estimate Comment
- Hazard ratio is comparing Pertuzumab arm with Placebo arm.
- group Description
- The null hypothesis (H0) was that the survival distributions of PFS in the two treatments arms (pertuzumab vs. placebo) are the same. The alternative hypothesis (H1) was that the survival distribution of PFS in the experimental arm (pertuzumab) and control arm (placebo) are different.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- <0.0001
- p Value Comment
- Tested at two-sided 5% significance level
- param Type
- Cox Proportional Hazard
- param Value
- 0.62
- statistical Comment
- Stratified by prior treatment status and region
- statistical Method
- Log Rank (stratified)
- ci Lower Limit
- 0.52
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.76
- estimate Comment
- Hazard ratio is comparing Pertuzumab arm with Placebo arm.
- group Description
- The null hypothesis (H0) was that the survival distributions of PFS in the two treatments arms (pertuzumab vs. placebo) are the same. The alternative hypothesis (H1) was that the survival distribution of PFS in the experimental arm (pertuzumab) and control arm (placebo) are different.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- <0.0001
- p Value Comment
- Tested at two-sided 5% significance level
- param Type
- Cox Proportional Hazard
- param Value
- 0.63
- statistical Comment
- Unstratified
- statistical Method
- Log Rank (unstratified)
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 15
- upper Limit
- 23
- value
- 18.5
- group Id
- OG001
- lower Limit
- 10
- upper Limit
- 13
- value
- 12.4
- denoms
- counts
- group Id
- OG000
- value
- 402
- group Id
- OG001
- value
- 406
- units
- Participants
- description
- PFS was defined as the time from randomization to first documented radiographical progressive disease (PD), as determined by an independent review facility (IRF) using RECIST version 1.0, or death from any cause (within 18 weeks of last tumor assessment), whichever occurred first (Kaplan-Meier method). For target lesions, PD was defined as at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum of the LD recorded since treatment started or the appearance of ≥1 new lesion. For non-target lesions, PD was defined as the appearance of ≥1 new lesion or unequivocal progression of existing lesions. Participants without IRF-determined PD or who had not died within 18 weeks of their last IRF-determined, progression-free tumor assessment were censored at the date of the last IRF-reviewed, evaluable tumor assessment; those with no post-baseline tumor assessment and who had not died within 18 weeks of baseline were censored at 1 day.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants randomized to this arm received pertuzumab 420 milligrams (mg) intravenously (IV) once every 3 weeks (q3w) and trastuzumab 6 milligrams per kilogram (mg/kg) IV q3w, plus docetaxel 75 milligrams per square metre of body surface (mg/m\^2) IV q3w (for at least 6 cycles; 1 cycle was 21 days). After Cycle 6, continuation of docetaxel treatment was at the discretion of the participant and treating physician. Participants remained in the treatment phase of the study until investigator-assessed radiographic or clinical evidence of disease progression, unmanageable toxicity, or study termination and were followed for survival until death, loss to follow-up, withdrawal of consent, or study termination.
- id
- OG000
- title
- Pertuzumab + Trastuzumab + Docetaxel
- description
- Participants randomized to this arm received placebo IV q3w and trastuzumab 6 mg/kg IV q3w, plus docetaxel 75 mg/m\^2 IV q3w (for at least 6 cycles; 1 cycle was 21 days). After Cycle 6, continuation of docetaxel treatment was at the discretion of the participant and treating physician. Participants remained in the treatment phase of the study until investigator-assessed radiographic or clinical evidence of disease progression, unmanageable toxicity, or study termination and were followed for survival until death, loss to follow-up, withdrawal of consent, or study termination.
- id
- OG001
- title
- Placebo + Trastuzumab + Docetaxel
- param Type
- MEDIAN
- population Description
- Intent-to-Treat (ITT) Population: All randomized participants
- reporting Status
- POSTED
- time Frame
- Tumor assessments every 9 weeks from randomization to IRF-determined PD or death from any cause, whichever occurred first, up to the primary completion date (up to 3 years, 3 months)
- title
- Progression-Free Survival (PFS) Determined by an Independent Review Facility
- type
- PRIMARY
- unit Of Measure
- Months
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Preserved source evidence · Not medical advice