TriangleNCT03674112 · OUTCOME
Kaplan-Meier Estimate of the Percentage of Participants Who Were Event-Free for Invasive Disease-Free Survival Including Second Primary Non-Breast Cancer, 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
Invasive Disease-Free Survival is defined as the time from randomization to the first occurrence of one of the following events: ipsilateral invasive breast tumour recurrence, ipsilateral local-regional invasive breast cancer recurrence, distant recurrence, contralateral invasive breast cancer, and death from any cause. Second primary non-breast invasive cancer (with the exception of non-melanoma skin cancers and in situ carcinoma of any site) was included as an event. 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 an invasive-disease free survival (including second primary non-breast cancer) 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 | 153 |
| A: P+H IV Followed by PH FDC SC | 75 |
| B: PH FDC SC Followed by P+H IV | 78 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| All Participants | 97.46 | Not reported | 95.00 | 99.92 | Not reported |
| A: P+H IV Followed by PH FDC SC | 94.94 | Not reported | 90.10 | 99.77 | 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 | 143 |
| A: P+H IV Followed by PH FDC SC | 71 |
| B: PH FDC SC Followed by P+H IV | 72 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| All Participants | 94.87 | Not reported | 91.40 | 98.33 | Not reported |
| A: P+H IV Followed by PH FDC SC | 92.37 | Not reported | 86.50 | 98.24 | 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 | 82 |
| A: P+H IV Followed by PH FDC SC | 36 |
| B: PH FDC SC Followed by P+H IV | 46 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| All Participants | 93.53 | Not reported | 89.65 | 97.41 | Not reported |
| A: P+H IV Followed by PH FDC SC | 91.05 | Not reported | 84.72 | 97.38 | 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
- 95.00
- upper Limit
- 99.92
- value
- 97.46
- group Id
- OG001
- lower Limit
- 90.10
- upper Limit
- 99.77
- value
- 94.94
- group Id
- OG002
- lower Limit
- 100.00
- upper Limit
- 100.00
- value
- 100.00
- denoms
- counts
- group Id
- OG000
- value
- 153
- group Id
- OG001
- value
- 75
- group Id
- OG002
- value
- 78
- units
- Participants
- title
- 12 Months
- categories
- measurements
- group Id
- OG000
- lower Limit
- 91.40
- upper Limit
- 98.33
- value
- 94.87
- group Id
- OG001
- lower Limit
- 86.50
- upper Limit
- 98.24
- value
- 92.37
- group Id
- OG002
- lower Limit
- 93.80
- upper Limit
- 100.00
- value
- 97.38
- denoms
- counts
- group Id
- OG000
- value
- 143
- group Id
- OG001
- value
- 71
- group Id
- OG002
- value
- 72
- units
- Participants
- title
- 24 Months
- categories
- measurements
- group Id
- OG000
- lower Limit
- 89.65
- upper Limit
- 97.41
- value
- 93.53
- group Id
- OG001
- lower Limit
- 84.72
- upper Limit
- 97.38
- value
- 91.05
- group Id
- OG002
- lower Limit
- 91.63
- upper Limit
- 100.00
- value
- 96.03
- denoms
- counts
- group Id
- OG000
- value
- 82
- group Id
- OG001
- value
- 36
- 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
- Invasive Disease-Free Survival is defined as the time from randomization to the first occurrence of one of the following events: ipsilateral invasive breast tumour recurrence, ipsilateral local-regional invasive breast cancer recurrence, distant recurrence, contralateral invasive breast cancer, and death from any cause. Second primary non-breast invasive cancer (with the exception of non-melanoma skin cancers and in situ carcinoma of any site) was included as an event. 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 an invasive-disease free survival (including second primary non-breast cancer) 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 Invasive Disease-Free Survival Including Second Primary Non-Breast Cancer, Overall and by Treatment Sequence
- type
- SECONDARY
- unit Of Measure
- Percentage of participants
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Preserved source evidence · Not medical advice