TriangleNCT01401166 · OUTCOME
Percentage of Participants With Anti-Trastuzumab or Anti-Recombinant Human Hyaluronidase (rHuPH20) Antibodies
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
- Baseline, pre-dose (0 hours) during Cycle 5 (cycle length of 3 weeks)
What was measured
Participants in Cohort 1 provided blood samples for immunogenicity testing to assess for anti-drug antibodies (ADAs) to trastuzumab or rHuPH20, a component of the SC Herceptin formulation. The percentage of participants who were trastuzumab ADA-positive and the percentage of participants who were rHuPH20 ADA-positive were each reported.
Analysis population: Safety Population. Results were planned to be analyzed for only Cohort 1 because the objective of the study was to evaluate immunogenicity within participants who received the SID formulation of Herceptin. The number of participants who provided ADA samples at each timepoint (n) is shown in the table.
Groups in this outcome
Cohort 1: SC (SID) Then IV Herceptin
Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. During Cycles 1 to 4 of the crossover period, SC Herceptin was administered via SID, and during Cycles 5 to 8, IV Herceptin was given. In the continuation period, participants received IV Herceptin for up to 10 remaining cycles. Administration was performed by HCP. Those with at least 2 treatment cycles remaining of the 18-cycle treatment course after the crossover period were offered the opportunity to self-administer SC Herceptin via SID under the direction of a trained HCP. The SC dose was 600 mg for all cycles where SC Herceptin was given, and the IV dose was 6 mg/kg for all cycles where IV Herceptin was given.
Cohort 1: IV Then SC (SID) Herceptin
Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. During Cycles 1 to 4 of the crossover period, IV Herceptin was given, and during Cycles 5 to 8, SC Herceptin was administered via SID. In the continuation period, participants received IV Herceptin for up to 10 remaining cycles. Administration was performed by HCP. Those with at least 2 treatment cycles remaining of the 18-cycle treatment course after the crossover period were offered the opportunity to self-administer SC Herceptin via SID under the direction of a trained HCP. The IV dose was a loading dose of 8 mg/kg in Cycle 1 for de novo participants who started Herceptin treatment in the study, and a dose of 6 mg/kg for all subsequent cycles where IV Herceptin was given and for non-de novo participants. The SC dose was 600 mg for all cycles where SC Herceptin was given.
| Group | Source count |
|---|---|
| Cohort 1: SC (SID) Then IV Herceptin | 122 |
| Cohort 1: IV Then SC (SID) Herceptin | 122 |
Reported measurements
Trastuzumab ADA-Positive, Baseline (n=120,121)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort 1: SC (SID) Then IV Herceptin | 2.5 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1: IV Then SC (SID) Herceptin | 4.1 | Not reported | Not reported | Not reported | Not reported |
Trastuzumab ADA-Positive, Cycle 5 (n=114,119)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort 1: SC (SID) Then IV Herceptin | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1: IV Then SC (SID) Herceptin | 3.4 | Not reported | Not reported | Not reported | Not reported |
rHuPH20 ADA-Positive, Baseline (n=120,121)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort 1: SC (SID) Then IV Herceptin | 5.8 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1: IV Then SC (SID) Herceptin | 7.4 | Not reported | Not reported | Not reported | Not reported |
rHuPH20 ADA-Positive, Cycle 5 (n=115,119)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort 1: SC (SID) Then IV Herceptin | 2.6 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1: IV Then SC (SID) Herceptin | 7.6 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 2.5
- group Id
- OG001
- value
- 4.1
- title
- Trastuzumab ADA-Positive, Baseline (n=120,121)
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 3.4
- title
- Trastuzumab ADA-Positive, Cycle 5 (n=114,119)
- categories
- measurements
- group Id
- OG000
- value
- 5.8
- group Id
- OG001
- value
- 7.4
- title
- rHuPH20 ADA-Positive, Baseline (n=120,121)
- categories
- measurements
- group Id
- OG000
- value
- 2.6
- group Id
- OG001
- value
- 7.6
- title
- rHuPH20 ADA-Positive, Cycle 5 (n=115,119)
- denoms
- counts
- group Id
- OG000
- value
- 122
- group Id
- OG001
- value
- 122
- units
- Participants
- description
- Participants in Cohort 1 provided blood samples for immunogenicity testing to assess for anti-drug antibodies (ADAs) to trastuzumab or rHuPH20, a component of the SC Herceptin formulation. The percentage of participants who were trastuzumab ADA-positive and the percentage of participants who were rHuPH20 ADA-positive were each reported.
- groups
- description
- Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. During Cycles 1 to 4 of the crossover period, SC Herceptin was administered via SID, and during Cycles 5 to 8, IV Herceptin was given. In the continuation period, participants received IV Herceptin for up to 10 remaining cycles. Administration was performed by HCP. Those with at least 2 treatment cycles remaining of the 18-cycle treatment course after the crossover period were offered the opportunity to self-administer SC Herceptin via SID under the direction of a trained HCP. The SC dose was 600 mg for all cycles where SC Herceptin was given, and the IV dose was 6 mg/kg for all cycles where IV Herceptin was given.
- id
- OG000
- title
- Cohort 1: SC (SID) Then IV Herceptin
- description
- Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. During Cycles 1 to 4 of the crossover period, IV Herceptin was given, and during Cycles 5 to 8, SC Herceptin was administered via SID. In the continuation period, participants received IV Herceptin for up to 10 remaining cycles. Administration was performed by HCP. Those with at least 2 treatment cycles remaining of the 18-cycle treatment course after the crossover period were offered the opportunity to self-administer SC Herceptin via SID under the direction of a trained HCP. The IV dose was a loading dose of 8 mg/kg in Cycle 1 for de novo participants who started Herceptin treatment in the study, and a dose of 6 mg/kg for all subsequent cycles where IV Herceptin was given and for non-de novo participants. The SC dose was 600 mg for all cycles where SC Herceptin was given.
- id
- OG001
- title
- Cohort 1: IV Then SC (SID) Herceptin
- param Type
- NUMBER
- population Description
- Safety Population. Results were planned to be analyzed for only Cohort 1 because the objective of the study was to evaluate immunogenicity within participants who received the SID formulation of Herceptin. The number of participants who provided ADA samples at each timepoint (n) is shown in the table.
- reporting Status
- POSTED
- time Frame
- Baseline, pre-dose (0 hours) during Cycle 5 (cycle length of 3 weeks)
- title
- Percentage of Participants With Anti-Trastuzumab or Anti-Recombinant Human Hyaluronidase (rHuPH20) Antibodies
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice