TriangleNCT03674112 · OUTCOME
Percentage of Participants by Their Choice of Treatment in the Treatment Continuation Period (PH FDC SC or P+H IV) and by Consistency of This Choice With Their Preferred Method of Administration Reported in Question 1 of the 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
- Not reported
- Time frame
- Cycle 6 Day 1 (each cycle is 21 days)
What was measured
At treatment Cycle 6, Day 1, participants were expected to select the study treatment formulation (PH FDC SC or P+H IV) they would receive during the Treatment Continuation Period (starting at Cycle 7) to complete their 18 cycles of neo/adjuvant HER2-targeted treatment. Additionally, for each participant's preference category (SC, IV, and No preference) as per the question 1 of the patient preference questionnaire (PPQ), the percentage of participants who selected each treatment administration route for the Treatment Continuation Period (PH FDC SC or P+H IV) was summarized.
Analysis population: All randomized participants, allocated to their randomized treatment arm.
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
Chose PH FDC SC for Treatment Continuation
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| All Participants | 86.9 | Not reported | Not reported | Not reported | Not reported |
| A: P+H IV Followed by PH FDC SC | 88.8 | Not reported | Not reported | Not reported | Not reported |
| B: PH FDC SC Followed by P+H IV | 85.0 | Not reported | Not reported | Not reported | Not reported |
Chose P+H IV for Treatment Continuation
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| All Participants | 13.1 | Not reported | Not reported | Not reported | Not reported |
| A: P+H IV Followed by PH FDC SC | 11.3 | Not reported | Not reported | Not reported | Not reported |
| B: PH FDC SC Followed by P+H IV | 15.0 | Not reported | Not reported | Not reported | Not reported |
Preferred SC per the PPQ and Chose PH FDC SC for Continuation
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| All Participants | 85.0 | Not reported | Not reported | Not reported | Not reported |
| A: P+H IV Followed by PH FDC SC | 87.5 | Not reported | Not reported | Not reported | Not reported |
| B: PH FDC SC Followed by P+H IV | 82.5 | Not reported | Not reported | Not reported | Not reported |
Preferred SC per the PPQ and Chose P+H IV for Continuation
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| All Participants | 0.0 | Not reported | Not reported | Not reported | Not reported |
| A: P+H IV Followed by PH FDC SC | 0.0 | Not reported | Not reported | Not reported | Not reported |
| B: PH FDC SC Followed by P+H IV | 0.0 | Not reported | Not reported | Not reported | Not reported |
Preferred IV per the PPQ and Chose PH FDC SC for Continuation
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| All Participants | 0.6 | Not reported | Not reported | Not reported | Not reported |
| A: P+H IV Followed by PH FDC SC | 1.3 | Not reported | Not reported | Not reported | Not reported |
| B: PH FDC SC Followed by P+H IV | 0.0 | Not reported | Not reported | Not reported | Not reported |
Preferred IV per the PPQ and Chose P+H IV for Continuation
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| All Participants | 13.1 | Not reported | Not reported | Not reported | Not reported |
| A: P+H IV Followed by PH FDC SC | 11.3 | Not reported | Not reported | Not reported | Not reported |
| B: PH FDC SC Followed by P+H IV | 15.0 | Not reported | Not reported | Not reported | Not reported |
No Preference per the PPQ and Chose PH FDC SC for Continuation
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| All Participants | 1.3 | Not reported | Not reported | Not reported | Not reported |
| A: P+H IV Followed by PH FDC SC | 0.0 | Not reported | Not reported | Not reported | Not reported |
| B: PH FDC SC Followed by P+H IV | 2.5 | Not reported | Not reported | Not reported | Not reported |
No Preference per the PPQ and Chose P+H IV for Continuation
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| All Participants | 0.0 | Not reported | Not reported | Not reported | Not reported |
| A: P+H IV Followed by PH FDC SC | 0.0 | Not reported | Not reported | Not reported | Not reported |
| B: PH FDC SC Followed by P+H IV | 0.0 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 86.9
- group Id
- OG001
- value
- 88.8
- group Id
- OG002
- value
- 85.0
- title
- Chose PH FDC SC for Treatment Continuation
- categories
- measurements
- group Id
- OG000
- value
- 13.1
- group Id
- OG001
- value
- 11.3
- group Id
- OG002
- value
- 15.0
- title
- Chose P+H IV for Treatment Continuation
- categories
- measurements
- group Id
- OG000
- value
- 85.0
- group Id
- OG001
- value
- 87.5
- group Id
- OG002
- value
- 82.5
- title
- Preferred SC per the PPQ and Chose PH FDC SC for Continuation
- categories
- measurements
- group Id
- OG000
- value
- 0.0
- group Id
- OG001
- value
- 0.0
- group Id
- OG002
- value
- 0.0
- title
- Preferred SC per the PPQ and Chose P+H IV for Continuation
- categories
- measurements
- group Id
- OG000
- value
- 0.6
- group Id
- OG001
- value
- 1.3
- group Id
- OG002
- value
- 0.0
- title
- Preferred IV per the PPQ and Chose PH FDC SC for Continuation
- categories
- measurements
- group Id
- OG000
- value
- 13.1
- group Id
- OG001
- value
- 11.3
- group Id
- OG002
- value
- 15.0
- title
- Preferred IV per the PPQ and Chose P+H IV for Continuation
- categories
- measurements
- group Id
- OG000
- value
- 1.3
- group Id
- OG001
- value
- 0.0
- group Id
- OG002
- value
- 2.5
- title
- No Preference per the PPQ and Chose PH FDC SC for Continuation
- categories
- measurements
- group Id
- OG000
- value
- 0.0
- group Id
- OG001
- value
- 0.0
- group Id
- OG002
- value
- 0.0
- title
- No Preference per the PPQ and Chose P+H IV for Continuation
- denoms
- counts
- group Id
- OG000
- value
- 160
- group Id
- OG001
- value
- 80
- group Id
- OG002
- value
- 80
- units
- Participants
- description
- At treatment Cycle 6, Day 1, participants were expected to select the study treatment formulation (PH FDC SC or P+H IV) they would receive during the Treatment Continuation Period (starting at Cycle 7) to complete their 18 cycles of neo/adjuvant HER2-targeted treatment. Additionally, for each participant's preference category (SC, IV, and No preference) as per the question 1 of the patient preference questionnaire (PPQ), the percentage of participants who selected each treatment administration route for the Treatment Continuation Period (PH FDC SC or P+H IV) was summarized.
- 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
- All randomized participants, allocated to their randomized treatment arm.
- reporting Status
- POSTED
- time Frame
- Cycle 6 Day 1 (each cycle is 21 days)
- title
- Percentage of Participants by Their Choice of Treatment in the Treatment Continuation Period (PH FDC SC or P+H IV) and by Consistency of This Choice With Their Preferred Method of Administration Reported in Question 1 of the PPQ
- type
- SECONDARY
- unit Of Measure
- Percentage of participants
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Preserved source evidence · Not medical advice