TriangleNCT00567190 · OUTCOME
Cardiac-Related AEs to Monitor: Number of Participants Who Experienced at Least One Symptomatic Left Ventricular Dysfunction (LVD), Any LVD, or Serious AE Suggestive of Congestive Heart Failure by Severity During the Treatment Period
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- Placebo arm: Baseline to last dose of study treatment +42 days (or crossover date); Pertuzumab arm: Baseline to last dose of study treatment +42 days; Crossover arm: Crossover date to last dose of study treatment +42 days (see Description - time per arm)
What was measured
Cardiac-related adverse events (AEs) to monitor during the study included investigator-assessed symptomatic left ventricular dysfunction (LVD), any LVD, or a serious adverse event (SAE) suggestive of congestive heart failure (CHF). All cardiac-related AEs were graded for severity according to NCI-CTCAE v3.0. Asymptomatic (Grades 1-2) and symptomatic (Grades 3-5) left ventricular systolic dysfunction (LVSD) both coded to the MedDRA preferred term LVD. Investigator-assessed events of symptomatic LVD were also graded for severity of symptoms according to Classes I (least severe) to IV (most severe) of the New York Heart Association (NYHA) Classification. SAEs suggestive of CHF were identified as serious events from the Standardized MedDRA Query (SMQ) (Wide) 'Cardiac Failure'. Median \[range\] time on study treatment per arm: Placebo: 49.3 \[0.3-514.7\] weeks; Pertuzumab: 75.7 \[0.6-519.6\] weeks; Crossover: 129.9 \[0.3-322.3\] weeks.
Analysis population: Safety Population: All participants who received at least one dose of any study medication.
Groups in this outcome
Placebo + Trastuzumab + Docetaxel
This is the placebo safety population, which includes participants who received study treatment with placebo at every cycle. Participants received placebo IV q3w and trastuzumab 6 mg/kg IV q3This is the placebo safety population, which includes participants who received study treatment with placebo at every cycle. Participants 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.
Pertuzumab + Trastuzumab + Docetaxel
This is the pertuzumab safety population, which includes participants who received at least one dose of study treatment with pertuzumab. Participants 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.
Crossover From Placebo to Pertuzumab
Fifty of 406 participants (12.3%) randomized to the placebo treatment arm whose disease had not progressed crossed over to an open-label pertuzumab treatment group between July 2012 and November 2018. Participants received pertuzumab administered as an IV loading dose of 840 mg at cycle 1 then 420 mg IV every q3w. Trastuzumab and docetaxel doses continued in accordance with the pre-crossover placebo treatment regimens and according to dosing specifications indicated in the study protocol. 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 |
|---|---|
| Placebo + Trastuzumab + Docetaxel | 396 |
| Pertuzumab + Trastuzumab + Docetaxel | 408 |
| Crossover From Placebo to Pertuzumab | 50 |
Reported measurements
Symptomatic LVD(Investigator)-All NYHA Classes
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Placebo + Trastuzumab + Docetaxel | 7 | Not reported | Not reported | Not reported | Not reported |
| Pertuzumab + Trastuzumab + Docetaxel | 6 | Not reported | Not reported | Not reported | Not reported |
| Crossover From Placebo to Pertuzumab | 1 | Not reported | Not reported | Not reported | Not reported |
Symptomatic LVD(Investigator)-NYHA Classes III/IV
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Placebo + Trastuzumab + Docetaxel | 4 | Not reported | Not reported | Not reported | Not reported |
| Pertuzumab + Trastuzumab + Docetaxel | 4 | Not reported | Not reported | Not reported | Not reported |
| Crossover From Placebo to Pertuzumab | 1 | Not reported | Not reported | Not reported | Not reported |
Any LVD - All NCI-CTCAE Grades
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Placebo + Trastuzumab + Docetaxel | 34 | Not reported | Not reported | Not reported | Not reported |
| Pertuzumab + Trastuzumab + Docetaxel | 32 | Not reported | Not reported | Not reported | Not reported |
| Crossover From Placebo to Pertuzumab | 3 | Not reported | Not reported | Not reported | Not reported |
Any LVD - NCI-CTCAE Grade ≥3
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Placebo + Trastuzumab + Docetaxel | 13 | Not reported | Not reported | Not reported | Not reported |
| Pertuzumab + Trastuzumab + Docetaxel | 6 | Not reported | Not reported | Not reported | Not reported |
| Crossover From Placebo to Pertuzumab | 2 | Not reported | Not reported | Not reported | Not reported |
SAE Suggestive of CHF - All NCI-CTCAE Grades
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Placebo + Trastuzumab + Docetaxel | 8 | Not reported | Not reported | Not reported | Not reported |
| Pertuzumab + Trastuzumab + Docetaxel | 8 | Not reported | Not reported | Not reported | Not reported |
| Crossover From Placebo to Pertuzumab | 1 | Not reported | Not reported | Not reported | Not reported |
SAE Suggestive of CHF - NCI-CTCAE Grade ≥3
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Placebo + Trastuzumab + Docetaxel | 7 | Not reported | Not reported | Not reported | Not reported |
| Pertuzumab + Trastuzumab + Docetaxel | 7 | Not reported | Not reported | Not reported | Not reported |
| Crossover From Placebo to Pertuzumab | 1 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 7
- group Id
- OG001
- value
- 6
- group Id
- OG002
- value
- 1
- title
- Symptomatic LVD(Investigator)-All NYHA Classes
- categories
- measurements
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 4
- group Id
- OG002
- value
- 1
- title
- Symptomatic LVD(Investigator)-NYHA Classes III/IV
- categories
- measurements
- group Id
- OG000
- value
- 34
- group Id
- OG001
- value
- 32
- group Id
- OG002
- value
- 3
- title
- Any LVD - All NCI-CTCAE Grades
- categories
- measurements
- group Id
- OG000
- value
- 13
- group Id
- OG001
- value
- 6
- group Id
- OG002
- value
- 2
- title
- Any LVD - NCI-CTCAE Grade ≥3
- categories
- measurements
- group Id
- OG000
- value
- 8
- group Id
- OG001
- value
- 8
- group Id
- OG002
- value
- 1
- title
- SAE Suggestive of CHF - All NCI-CTCAE Grades
- categories
- measurements
- group Id
- OG000
- value
- 7
- group Id
- OG001
- value
- 7
- group Id
- OG002
- value
- 1
- title
- SAE Suggestive of CHF - NCI-CTCAE Grade ≥3
- denoms
- counts
- group Id
- OG000
- value
- 396
- group Id
- OG001
- value
- 408
- group Id
- OG002
- value
- 50
- units
- Participants
- description
- Cardiac-related adverse events (AEs) to monitor during the study included investigator-assessed symptomatic left ventricular dysfunction (LVD), any LVD, or a serious adverse event (SAE) suggestive of congestive heart failure (CHF). All cardiac-related AEs were graded for severity according to NCI-CTCAE v3.0. Asymptomatic (Grades 1-2) and symptomatic (Grades 3-5) left ventricular systolic dysfunction (LVSD) both coded to the MedDRA preferred term LVD. Investigator-assessed events of symptomatic LVD were also graded for severity of symptoms according to Classes I (least severe) to IV (most severe) of the New York Heart Association (NYHA) Classification. SAEs suggestive of CHF were identified as serious events from the Standardized MedDRA Query (SMQ) (Wide) 'Cardiac Failure'. Median \[range\] time on study treatment per arm: Placebo: 49.3 \[0.3-514.7\] weeks; Pertuzumab: 75.7 \[0.6-519.6\] weeks; Crossover: 129.9 \[0.3-322.3\] weeks.
- groups
- description
- This is the placebo safety population, which includes participants who received study treatment with placebo at every cycle. Participants received placebo IV q3w and trastuzumab 6 mg/kg IV q3This is the placebo safety population, which includes participants who received study treatment with placebo at every cycle. Participants 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
- OG000
- title
- Placebo + Trastuzumab + Docetaxel
- description
- This is the pertuzumab safety population, which includes participants who received at least one dose of study treatment with pertuzumab. Participants 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
- OG001
- title
- Pertuzumab + Trastuzumab + Docetaxel
- description
- Fifty of 406 participants (12.3%) randomized to the placebo treatment arm whose disease had not progressed crossed over to an open-label pertuzumab treatment group between July 2012 and November 2018. Participants received pertuzumab administered as an IV loading dose of 840 mg at cycle 1 then 420 mg IV every q3w. Trastuzumab and docetaxel doses continued in accordance with the pre-crossover placebo treatment regimens and according to dosing specifications indicated in the study protocol. 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
- OG002
- title
- Crossover From Placebo to Pertuzumab
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Safety Population: All participants who received at least one dose of any study medication.
- reporting Status
- POSTED
- time Frame
- Placebo arm: Baseline to last dose of study treatment +42 days (or crossover date); Pertuzumab arm: Baseline to last dose of study treatment +42 days; Crossover arm: Crossover date to last dose of study treatment +42 days (see Description - time per arm)
- title
- Cardiac-Related AEs to Monitor: Number of Participants Who Experienced at Least One Symptomatic Left Ventricular Dysfunction (LVD), Any LVD, or Serious AE Suggestive of Congestive Heart Failure by Severity During the Treatment Period
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice