TriangleNCT03674112 · OUTCOME
Percentage of Participants by Their Preferred Method of Pertuzumab and Trastuzumab Administration, as Assessed in Question 1 of the Patient Preference Questionnaire (PPQ)
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
- Cycle 6 Day 1 (each cycle is 21 days)
What was measured
Question 1 of the Patient Preference Questionnaire (PPQ) asked participants the following question: "All things considered, which method of administration did you prefer?" The three available options for a participant's response were: IV, SC, or No preference. A point estimate with associated exact Clopper-Pearson binomial 95% confidence interval was calculated only for the percentage of participants who preferred PH FDC SC.
Analysis population: Modified Intent-to-Treat (mITT) Population: All randomized participants, allocated to their randomized treatment arm, who received at least one dose by both SC and IV routes of administration during the Treatment Cross-over Period and subsequently answered at least Question 1 of the PPQ.
Groups in this outcome
All Participants
In the Treatment Cross-Over Period of the study, all participants received their first 6 cycles of treatment in accordance with the study arm to which they were randomized: Arm A) pertuzumab IV and trastuzumab IV (P+H IV) for 3 treatment cycles followed by the pertuzumab and trastuzumab fixed-dose combination for subcutaneous administration (PH FDC SC) for 3 treatment cycles (1 cycle = 21 days); or Arm B) PH FDC SC for 3 treatment cycles followed by P+H IV for 3 treatment cycles (1 cycle = 21 days). Following completion of this study period, participants chose one of the two study treatments to receive in the Treatment Continuation Period for the remaining anti-HER2 treatment cycles (18 planned cycles in total, including pre-study neoadjuvant treatment). After completing study treatment, participants entered the Follow-up Period wherein they were to be followed for 3 years from the date the last participant was randomized.
A: P+H IV Followed by PH FDC SC
In the Treatment Cross-Over Period of the study, participants randomized to Arm A first received pertuzumab IV and trastuzumab IV (P+H IV) administration for 3 treatment cycles followed by the pertuzumab and trastuzumab fixed-dose combination for subcutaneous administration (PH FDC SC) for 3 treatment cycles (1 cycle = 21 days). Following completion of this study period, participants chose one of the two study treatments to receive in the Treatment Continuation Period for the remaining anti-HER2 treatment cycles (18 planned cycles in total, including pre-study neoadjuvant treatment). After completing study treatment, participants entered the Follow-up Period wherein they were to be followed for 3 years from the date the last participant was randomized.
B: PH FDC SC Followed by P+H IV
In the Treatment Cross-Over Period of the study, participants randomized to Arm B first received the pertuzumab and trastuzumab fixed-dose combination for subcutaneous administration (PH FDC SC) for 3 treatment cycles followed by pertuzumab intravenous (IV) and trastuzumab IV (P+H IV) administration for 3 treatment cycles (1 cycle = 21 days). Following completion of this study period, participants chose one of the two study treatments to receive in the Treatment Continuation Period for the remaining anti-HER2 treatment cycles (18 planned cycles in total, including pre-study neoadjuvant treatment). After completing study treatment, participants entered the Follow-up Period wherein they were to be followed for 3 years from the date the last participant was randomized.
| Group | Source count |
|---|---|
| All Participants | 160 |
| A: P+H IV Followed by PH FDC SC | 80 |
| B: PH FDC SC Followed by P+H IV | 80 |
Reported measurements
SC Preference
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| All Participants | 85.00 | Not reported | 78.51 | 90.15 | Not reported |
| A: P+H IV Followed by PH FDC SC | 87.50 | Not reported | 78.21 | 93.84 | Not reported |
| B: PH FDC SC Followed by P+H IV | 82.50 | Not reported | 72.38 | 90.09 | Not reported |
IV Preference
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| All Participants | 13.8 | Not reported | NA | NA | As per the statistical analysis plan, a 95% confidence interval was only calculated for the percentage of participants who preferred PH FDC SC. |
| A: P+H IV Followed by PH FDC SC | 12.5 | Not reported | NA | NA | As per the statistical analysis plan, a 95% confidence interval was only calculated for the percentage of participants who preferred PH FDC SC. |
| B: PH FDC SC Followed by P+H IV | 15.0 | Not reported | NA | NA | As per the statistical analysis plan, a 95% confidence interval was only calculated for the percentage of participants who preferred PH FDC SC. |
No Preference
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| All Participants | 1.3 | Not reported | NA | NA | As per the statistical analysis plan, a 95% confidence interval was only calculated for the percentage of participants who preferred PH FDC SC. |
| A: P+H IV Followed by PH FDC SC | 0.0 | Not reported | NA | NA | As per the statistical analysis plan, a 95% confidence interval was only calculated for the percentage of participants who preferred PH FDC SC. |
| B: PH FDC SC Followed by P+H IV | 2.5 | Not reported | NA | NA | As per the statistical analysis plan, a 95% confidence interval was only calculated for the percentage of participants who preferred PH FDC SC. |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 78.51
- upper Limit
- 90.15
- value
- 85.00
- group Id
- OG001
- lower Limit
- 78.21
- upper Limit
- 93.84
- value
- 87.50
- group Id
- OG002
- lower Limit
- 72.38
- upper Limit
- 90.09
- value
- 82.50
- title
- SC Preference
- categories
- measurements
- comment
- As per the statistical analysis plan, a 95% confidence interval was only calculated for the percentage of participants who preferred PH FDC SC.
- group Id
- OG000
- lower Limit
- NA
- upper Limit
- NA
- value
- 13.8
- comment
- As per the statistical analysis plan, a 95% confidence interval was only calculated for the percentage of participants who preferred PH FDC SC.
- group Id
- OG001
- lower Limit
- NA
- upper Limit
- NA
- value
- 12.5
- comment
- As per the statistical analysis plan, a 95% confidence interval was only calculated for the percentage of participants who preferred PH FDC SC.
- group Id
- OG002
- lower Limit
- NA
- upper Limit
- NA
- value
- 15.0
- title
- IV Preference
- categories
- measurements
- comment
- As per the statistical analysis plan, a 95% confidence interval was only calculated for the percentage of participants who preferred PH FDC SC.
- group Id
- OG000
- lower Limit
- NA
- upper Limit
- NA
- value
- 1.3
- comment
- As per the statistical analysis plan, a 95% confidence interval was only calculated for the percentage of participants who preferred PH FDC SC.
- group Id
- OG001
- lower Limit
- NA
- upper Limit
- NA
- value
- 0.0
- comment
- As per the statistical analysis plan, a 95% confidence interval was only calculated for the percentage of participants who preferred PH FDC SC.
- group Id
- OG002
- lower Limit
- NA
- upper Limit
- NA
- value
- 2.5
- title
- No Preference
- denoms
- counts
- group Id
- OG000
- value
- 160
- group Id
- OG001
- value
- 80
- group Id
- OG002
- value
- 80
- units
- Participants
- description
- Question 1 of the Patient Preference Questionnaire (PPQ) asked participants the following question: "All things considered, which method of administration did you prefer?" The three available options for a participant's response were: IV, SC, or No preference. A point estimate with associated exact Clopper-Pearson binomial 95% confidence interval was calculated only for the percentage of participants who preferred PH FDC SC.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- In the Treatment Cross-Over Period of the study, all participants received their first 6 cycles of treatment in accordance with the study arm to which they were randomized: Arm A) pertuzumab IV and trastuzumab IV (P+H IV) for 3 treatment cycles followed by the pertuzumab and trastuzumab fixed-dose combination for subcutaneous administration (PH FDC SC) for 3 treatment cycles (1 cycle = 21 days); or Arm B) PH FDC SC for 3 treatment cycles followed by P+H IV for 3 treatment cycles (1 cycle = 21 days). Following completion of this study period, participants chose one of the two study treatments to receive in the Treatment Continuation Period for the remaining anti-HER2 treatment cycles (18 planned cycles in total, including pre-study neoadjuvant treatment). After completing study treatment, participants entered the Follow-up Period wherein they were to be followed for 3 years from the date the last participant was randomized.
- id
- OG000
- title
- All Participants
- description
- In the Treatment Cross-Over Period of the study, participants randomized to Arm A first received pertuzumab IV and trastuzumab IV (P+H IV) administration for 3 treatment cycles followed by the pertuzumab and trastuzumab fixed-dose combination for subcutaneous administration (PH FDC SC) for 3 treatment cycles (1 cycle = 21 days). Following completion of this study period, participants chose one of the two study treatments to receive in the Treatment Continuation Period for the remaining anti-HER2 treatment cycles (18 planned cycles in total, including pre-study neoadjuvant treatment). After completing study treatment, participants entered the Follow-up Period wherein they were to be followed for 3 years from the date the last participant was randomized.
- id
- OG001
- title
- A: P+H IV Followed by PH FDC SC
- description
- In the Treatment Cross-Over Period of the study, participants randomized to Arm B first received the pertuzumab and trastuzumab fixed-dose combination for subcutaneous administration (PH FDC SC) for 3 treatment cycles followed by pertuzumab intravenous (IV) and trastuzumab IV (P+H IV) administration for 3 treatment cycles (1 cycle = 21 days). Following completion of this study period, participants chose one of the two study treatments to receive in the Treatment Continuation Period for the remaining anti-HER2 treatment cycles (18 planned cycles in total, including pre-study neoadjuvant treatment). After completing study treatment, participants entered the Follow-up Period wherein they were to be followed for 3 years from the date the last participant was randomized.
- id
- OG002
- title
- B: PH FDC SC Followed by P+H IV
- param Type
- NUMBER
- population Description
- Modified Intent-to-Treat (mITT) Population: All randomized participants, allocated to their randomized treatment arm, who received at least one dose by both SC and IV routes of administration during the Treatment Cross-over Period and subsequently answered at least Question 1 of the PPQ.
- reporting Status
- POSTED
- time Frame
- Cycle 6 Day 1 (each cycle is 21 days)
- title
- Percentage of Participants by Their Preferred Method of Pertuzumab and Trastuzumab Administration, as Assessed in Question 1 of the Patient Preference Questionnaire (PPQ)
- type
- PRIMARY
- unit Of Measure
- Percentage of participants
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Preserved source evidence · Not medical advice