TriangleNCT03674112 · OUTCOME
Kaplan-Meier Estimate of the Percentage of Participants Who Were Event-Free for Distant Disease-Free Survival, Overall and by Treatment Sequence
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
- At 12, 24, and 36 months
What was measured
Distant disease-free survival (DDFS) is defined as the time from randomization to the date of distant breast cancer recurrence (i.e., evidence of breast cancer in any anatomic site other than for ipsilateral \[loco-regional\] invasive breast cancer recurrence that has either been histologically confirmed or clinically diagnosed as recurrent invasive breast cancer). Participants who had not experienced invasive disease at the time of analysis were censored: i) at the time of the last clinical breast examination if they had post-baseline clinical breast examination; ii) on the date of randomization +1 day if no post-baseline clinical breast examination. Kaplan-Meier methodology was used to estimate the percentage of participants who were event-free at 12, 24, and 36 months.
Analysis population: ITT Population; the number analyzed at each landmark timepoint represents the number of participants who were remaining at risk for a distant disease-free survival event.
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
12 Months
| Group | Source count |
|---|---|
| All Participants | 155 |
| A: P+H IV Followed by PH FDC SC | 77 |
| B: PH FDC SC Followed by P+H IV | 78 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| All Participants | 98.73 | Not reported | 96.98 | 100.00 | Not reported |
| A: P+H IV Followed by PH FDC SC | 97.47 | Not reported | 94.00 | 100.00 | Not reported |
| B: PH FDC SC Followed by P+H IV | 100.00 | Not reported | 100.00 | 100.00 | Not reported |
24 Months
| Group | Source count |
|---|---|
| All Participants | 145 |
| A: P+H IV Followed by PH FDC SC | 73 |
| B: PH FDC SC Followed by P+H IV | 72 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| All Participants | 96.14 | Not reported | 93.11 | 99.17 | Not reported |
| A: P+H IV Followed by PH FDC SC | 94.90 | Not reported | 90.04 | 99.77 | Not reported |
| B: PH FDC SC Followed by P+H IV | 97.38 | Not reported | 93.80 | 100.00 | Not reported |
36 Months
| Group | Source count |
|---|---|
| All Participants | 83 |
| A: P+H IV Followed by PH FDC SC | 37 |
| B: PH FDC SC Followed by P+H IV | 46 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| All Participants | 94.80 | Not reported | 91.30 | 98.31 | Not reported |
| A: P+H IV Followed by PH FDC SC | 93.58 | Not reported | 88.14 | 99.03 | Not reported |
| B: PH FDC SC Followed by P+H IV | 96.03 | Not reported | 91.63 | 100.00 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 96.98
- upper Limit
- 100.00
- value
- 98.73
- group Id
- OG001
- lower Limit
- 94.00
- upper Limit
- 100.00
- value
- 97.47
- group Id
- OG002
- lower Limit
- 100.00
- upper Limit
- 100.00
- value
- 100.00
- denoms
- counts
- group Id
- OG000
- value
- 155
- group Id
- OG001
- value
- 77
- group Id
- OG002
- value
- 78
- units
- Participants
- title
- 12 Months
- categories
- measurements
- group Id
- OG000
- lower Limit
- 93.11
- upper Limit
- 99.17
- value
- 96.14
- group Id
- OG001
- lower Limit
- 90.04
- upper Limit
- 99.77
- value
- 94.90
- group Id
- OG002
- lower Limit
- 93.80
- upper Limit
- 100.00
- value
- 97.38
- denoms
- counts
- group Id
- OG000
- value
- 145
- group Id
- OG001
- value
- 73
- group Id
- OG002
- value
- 72
- units
- Participants
- title
- 24 Months
- categories
- measurements
- group Id
- OG000
- lower Limit
- 91.30
- upper Limit
- 98.31
- value
- 94.80
- group Id
- OG001
- lower Limit
- 88.14
- upper Limit
- 99.03
- value
- 93.58
- group Id
- OG002
- lower Limit
- 91.63
- upper Limit
- 100.00
- value
- 96.03
- denoms
- counts
- group Id
- OG000
- value
- 83
- group Id
- OG001
- value
- 37
- group Id
- OG002
- value
- 46
- units
- Participants
- title
- 36 Months
- denoms
- counts
- group Id
- OG000
- value
- 160
- group Id
- OG001
- value
- 80
- group Id
- OG002
- value
- 80
- units
- Participants
- description
- Distant disease-free survival (DDFS) is defined as the time from randomization to the date of distant breast cancer recurrence (i.e., evidence of breast cancer in any anatomic site other than for ipsilateral \[loco-regional\] invasive breast cancer recurrence that has either been histologically confirmed or clinically diagnosed as recurrent invasive breast cancer). Participants who had not experienced invasive disease at the time of analysis were censored: i) at the time of the last clinical breast examination if they had post-baseline clinical breast examination; ii) on the date of randomization +1 day if no post-baseline clinical breast examination. Kaplan-Meier methodology was used to estimate the percentage of participants who were event-free at 12, 24, and 36 months.
- 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
- ITT Population; the number analyzed at each landmark timepoint represents the number of participants who were remaining at risk for a distant disease-free survival event.
- reporting Status
- POSTED
- time Frame
- At 12, 24, and 36 months
- title
- Kaplan-Meier Estimate of the Percentage of Participants Who Were Event-Free for Distant Disease-Free Survival, Overall and by Treatment Sequence
- type
- SECONDARY
- unit Of Measure
- Percentage of participants
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Preserved source evidence · Not medical advice