TriangleNCT02132949 · OUTCOME
Percentage of Participants Positive for Anti-Therapeutic Antibodies (ATAs) to Pertuzumab at Baseline and Anytime Post-Baseline
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
- Not reported
- Time frame
- Screening (baseline) then prior to pertuzumab infusion (Hour 0) in Cycles 5, 14, 18 thereafter anytime between Cycle 8 Day 21 and surgery, up to treatment completion visit (cycle length=2-3 weeks; up to approximately 1 year, 3 months)
What was measured
ATAs to pertuzumab in serum samples were detected using a validated bridging enzyme-linked immunosorbent assay (ELISA) method. This analysis only included participants with an ATA assay result from a baseline sample and/or at least one post-baseline sample.
Analysis population: This analysis only included participants with an ATA assay result from a baseline sample and/or at least one post-baseline sample.
Groups in this outcome
Cohort A: ddAC, Paclitaxel, Pertuzumab, Trastuzumab
Participants received neoadjuvant treatment with dose-dense doxorubicin and cyclophosphamide (ddAC), with administration of doxorubicin 60 milligrams per square meter (mg/m\^2) intravenously (IV) once every 2 weeks (q2w) and cyclophosphamide 600mg/m\^2 IV q2w for 4 cycles, followed by paclitaxel 80mg/m\^2 IV once weekly (qw) for 12 weeks. Pertuzumab (840 milligrams \[mg\] IV loading dose then 420mg IV q3w) and trastuzumab (8 milligrams per kilogram \[mg/kg\] IV loading dose then 4mg/kg IV q3w) were administered along with paclitaxel for 4 cycles (8 cycles of chemotherapy in total prior to surgery). Following surgery, participants received adjuvant treatment with pertuzumab and trastuzumab IV q3w (up to 13 cycles), for a total of 17 cycles of pertuzumab and trastuzumab therapy during the study. Radiotherapy and adjuvant hormonal therapy were also given as clinically indicated. Following treatment completion/discontinuation, participants were followed for safety and efficacy for up to 5 years.
Cohort B: FEC, Docetaxel, Pertuzumab, Trastuzumab
Participants received neoadjuvant treatment with 5-fluorouracil, epirubicin, and cyclophosphamide (FEC), with administration of 5-fluorouracil 500mg/m\^2 intravenously (IV) q3w, epirubicin 100mg/m\^2 IV q3w, and cyclophosphamide 600mg/m\^2 IV q3w for 4 cycles, followed by docetaxel (with starting dose of 75mg/m\^2 in Cycle 5, then 100mg/m\^2 for Cycles 6-8) q3w for 4 cycles. Pertuzumab (840 mg IV loading dose then 420mg IV q3w) and trastuzumab (8 mg/kg IV loading dose then 4mg/kg IV q3w) were given along with doectaxel for 4 cycles (8 cycles of chemotherapy in total prior to surgery). Following surgery, participants received adjuvant treatment with pertuzumab and trastuzumab IV q3w (up to 13 cycles), for a total of 17 cycles of pertuzumab and trastuzumab therapy during the study. Radiotherapy and adjuvant hormonal therapy were also given as clinically indicated. Following treatment completion/discontinuation, participants were followed for safety and efficacy for up to 5 years.
| Group | Source count |
|---|---|
| Cohort A: ddAC, Paclitaxel, Pertuzumab, Trastuzumab | 199 |
| Cohort B: FEC, Docetaxel, Pertuzumab, Trastuzumab | 201 |
Reported measurements
At Baseline
| Group | Source count |
|---|---|
| Cohort A: ddAC, Paclitaxel, Pertuzumab, Trastuzumab | 190 |
| Cohort B: FEC, Docetaxel, Pertuzumab, Trastuzumab | 191 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort A: ddAC, Paclitaxel, Pertuzumab, Trastuzumab | 1.6 | Not reported | Not reported | Not reported | Not reported |
| Cohort B: FEC, Docetaxel, Pertuzumab, Trastuzumab | 2.1 | Not reported | Not reported | Not reported | Not reported |
Anytime Post-Baseline
| Group | Source count |
|---|---|
| Cohort A: ddAC, Paclitaxel, Pertuzumab, Trastuzumab | 195 |
| Cohort B: FEC, Docetaxel, Pertuzumab, Trastuzumab | 197 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort A: ddAC, Paclitaxel, Pertuzumab, Trastuzumab | 4.6 | Not reported | Not reported | Not reported | Not reported |
| Cohort B: FEC, Docetaxel, Pertuzumab, Trastuzumab | 3.6 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 1.6
- group Id
- OG001
- value
- 2.1
- denoms
- counts
- group Id
- OG000
- value
- 190
- group Id
- OG001
- value
- 191
- units
- Participants
- title
- At Baseline
- categories
- measurements
- group Id
- OG000
- value
- 4.6
- group Id
- OG001
- value
- 3.6
- denoms
- counts
- group Id
- OG000
- value
- 195
- group Id
- OG001
- value
- 197
- units
- Participants
- title
- Anytime Post-Baseline
- denoms
- counts
- group Id
- OG000
- value
- 199
- group Id
- OG001
- value
- 201
- units
- Participants
- description
- ATAs to pertuzumab in serum samples were detected using a validated bridging enzyme-linked immunosorbent assay (ELISA) method. This analysis only included participants with an ATA assay result from a baseline sample and/or at least one post-baseline sample.
- groups
- description
- Participants received neoadjuvant treatment with dose-dense doxorubicin and cyclophosphamide (ddAC), with administration of doxorubicin 60 milligrams per square meter (mg/m\^2) intravenously (IV) once every 2 weeks (q2w) and cyclophosphamide 600mg/m\^2 IV q2w for 4 cycles, followed by paclitaxel 80mg/m\^2 IV once weekly (qw) for 12 weeks. Pertuzumab (840 milligrams \[mg\] IV loading dose then 420mg IV q3w) and trastuzumab (8 milligrams per kilogram \[mg/kg\] IV loading dose then 4mg/kg IV q3w) were administered along with paclitaxel for 4 cycles (8 cycles of chemotherapy in total prior to surgery). Following surgery, participants received adjuvant treatment with pertuzumab and trastuzumab IV q3w (up to 13 cycles), for a total of 17 cycles of pertuzumab and trastuzumab therapy during the study. Radiotherapy and adjuvant hormonal therapy were also given as clinically indicated. Following treatment completion/discontinuation, participants were followed for safety and efficacy for up to 5 years.
- id
- OG000
- title
- Cohort A: ddAC, Paclitaxel, Pertuzumab, Trastuzumab
- description
- Participants received neoadjuvant treatment with 5-fluorouracil, epirubicin, and cyclophosphamide (FEC), with administration of 5-fluorouracil 500mg/m\^2 intravenously (IV) q3w, epirubicin 100mg/m\^2 IV q3w, and cyclophosphamide 600mg/m\^2 IV q3w for 4 cycles, followed by docetaxel (with starting dose of 75mg/m\^2 in Cycle 5, then 100mg/m\^2 for Cycles 6-8) q3w for 4 cycles. Pertuzumab (840 mg IV loading dose then 420mg IV q3w) and trastuzumab (8 mg/kg IV loading dose then 4mg/kg IV q3w) were given along with doectaxel for 4 cycles (8 cycles of chemotherapy in total prior to surgery). Following surgery, participants received adjuvant treatment with pertuzumab and trastuzumab IV q3w (up to 13 cycles), for a total of 17 cycles of pertuzumab and trastuzumab therapy during the study. Radiotherapy and adjuvant hormonal therapy were also given as clinically indicated. Following treatment completion/discontinuation, participants were followed for safety and efficacy for up to 5 years.
- id
- OG001
- title
- Cohort B: FEC, Docetaxel, Pertuzumab, Trastuzumab
- param Type
- NUMBER
- population Description
- This analysis only included participants with an ATA assay result from a baseline sample and/or at least one post-baseline sample.
- reporting Status
- POSTED
- time Frame
- Screening (baseline) then prior to pertuzumab infusion (Hour 0) in Cycles 5, 14, 18 thereafter anytime between Cycle 8 Day 21 and surgery, up to treatment completion visit (cycle length=2-3 weeks; up to approximately 1 year, 3 months)
- title
- Percentage of Participants Positive for Anti-Therapeutic Antibodies (ATAs) to Pertuzumab at Baseline and Anytime Post-Baseline
- type
- SECONDARY
- unit Of Measure
- Percentage of participants
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Preserved source evidence · Not medical advice