TriangleNCT01358877 · OUTCOME
Kaplan-Meier Estimate of the Percentage of Participants Who Were IDFS Event-Free (Excluding SPNBC) at 6, 8, and 10 Years, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Estimate of percentage of participants
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- 6, 8, and 10 years
What was measured
The Kaplan-Meier estimates of the percentage of participants who were IDFS event-free (excluding SPNBC) at 6, 8, and 10 years are reported. IDFS event was defined as the first occurrence of one of the following events: ipsilateral invasive breast tumor recurrence, ipsilateral local-regional invasive breast cancer recurrence, distant recurrence, death attributable to any cause, or contralateral invasive breast cancer. All SPNBCs and in situ carcinomas (including DCIS and LCIS) and non-melanoma skin cancer were excluded as an event. Participants who had not had an event at the time of data analysis were censored at the date last known to be alive and event-free.
Analysis population: The overall number of participants analyzed is the ITT population. The number analyzed is the number of participants remaining at risk for an event at the time of analysis for each timepoint.
Groups in this outcome
Pertuzumab + Trastuzumab + Chemotherapy
Participants received pertuzumab (840 mg loading dose, then 420 mg) and trastuzumab (8 mg/kg loading dose, then 6 mg/kg) IV Q3W for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 mg/m\^2 + epirubicin 90-120 mg/m\^2 or doxorubicin 50 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m\^2 for 3 cycles, 75 mg/m\^2 in first cycle and 100 mg/m\^2 in subsequent cycles, or 75 mg/m\^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m\^2 QW; 2) 4 cycles (Q3W) of doxorubicin 60 mg/m\^2 or epirubicin 90-120 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m\^2 + carboplatin area under the curve (AUC) 6 (up to 900 mg).
Placebo + Trastuzumab + Chemotherapy
Participants received placebo matched to pertuzumab IV Q3W and trastuzumab (8 mg/kg loading dose, then 6 mg/kg) IV Q3W for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 mg/m\^2 + epirubicin 90-120 mg/m\^2 or doxorubicin 50 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m\^2 for 3 cycles, 75 mg/m\^2 in first cycle and 100 mg/m\^2 in subsequent cycles, or 75 mg/m\^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m\^2 QW; 2) 4 cycles (Q3W) of doxorubicin 60 mg/m\^2 or epirubicin 90-120 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m\^2 + carboplatin AUC 6 (up to 900 mg).
| Group | Source count |
|---|---|
| Pertuzumab + Trastuzumab + Chemotherapy | 2400 |
| Placebo + Trastuzumab + Chemotherapy | 2404 |
Reported measurements
6 Years
| Group | Source count |
|---|---|
| Pertuzumab + Trastuzumab + Chemotherapy | 1482 |
| Placebo + Trastuzumab + Chemotherapy | 1421 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Pertuzumab + Trastuzumab + Chemotherapy | 90.56 | Not reported | 89.35 | 91.77 | Not reported |
| Placebo + Trastuzumab + Chemotherapy | 87.76 | Not reported | 86.40 | 89.13 | Not reported |
8 Years
| Group | Source count |
|---|---|
| Pertuzumab + Trastuzumab + Chemotherapy | 1677 |
| Placebo + Trastuzumab + Chemotherapy | 1651 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Pertuzumab + Trastuzumab + Chemotherapy | 88.43 | Not reported | 87.10 | 89.76 | Not reported |
| Placebo + Trastuzumab + Chemotherapy | 85.76 | Not reported | 84.32 | 87.21 | Not reported |
10 Years
| Group | Source count |
|---|---|
| Pertuzumab + Trastuzumab + Chemotherapy | 1646 |
| Placebo + Trastuzumab + Chemotherapy | 1589 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Pertuzumab + Trastuzumab + Chemotherapy | 87.17 | Not reported | 85.77 | 88.57 | Not reported |
| Placebo + Trastuzumab + Chemotherapy | 83.82 | Not reported | 82.29 | 85.36 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 89.35
- upper Limit
- 91.77
- value
- 90.56
- group Id
- OG001
- lower Limit
- 86.40
- upper Limit
- 89.13
- value
- 87.76
- denoms
- counts
- group Id
- OG000
- value
- 1482
- group Id
- OG001
- value
- 1421
- units
- Participants
- title
- 6 Years
- categories
- measurements
- group Id
- OG000
- lower Limit
- 87.10
- upper Limit
- 89.76
- value
- 88.43
- group Id
- OG001
- lower Limit
- 84.32
- upper Limit
- 87.21
- value
- 85.76
- denoms
- counts
- group Id
- OG000
- value
- 1677
- group Id
- OG001
- value
- 1651
- units
- Participants
- title
- 8 Years
- categories
- measurements
- group Id
- OG000
- lower Limit
- 85.77
- upper Limit
- 88.57
- value
- 87.17
- group Id
- OG001
- lower Limit
- 82.29
- upper Limit
- 85.36
- value
- 83.82
- denoms
- counts
- group Id
- OG000
- value
- 1646
- group Id
- OG001
- value
- 1589
- units
- Participants
- title
- 10 Years
- denoms
- counts
- group Id
- OG000
- value
- 2400
- group Id
- OG001
- value
- 2404
- units
- Participants
- description
- The Kaplan-Meier estimates of the percentage of participants who were IDFS event-free (excluding SPNBC) at 6, 8, and 10 years are reported. IDFS event was defined as the first occurrence of one of the following events: ipsilateral invasive breast tumor recurrence, ipsilateral local-regional invasive breast cancer recurrence, distant recurrence, death attributable to any cause, or contralateral invasive breast cancer. All SPNBCs and in situ carcinomas (including DCIS and LCIS) and non-melanoma skin cancer were excluded as an event. Participants who had not had an event at the time of data analysis were censored at the date last known to be alive and event-free.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received pertuzumab (840 mg loading dose, then 420 mg) and trastuzumab (8 mg/kg loading dose, then 6 mg/kg) IV Q3W for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 mg/m\^2 + epirubicin 90-120 mg/m\^2 or doxorubicin 50 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m\^2 for 3 cycles, 75 mg/m\^2 in first cycle and 100 mg/m\^2 in subsequent cycles, or 75 mg/m\^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m\^2 QW; 2) 4 cycles (Q3W) of doxorubicin 60 mg/m\^2 or epirubicin 90-120 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m\^2 + carboplatin area under the curve (AUC) 6 (up to 900 mg).
- id
- OG000
- title
- Pertuzumab + Trastuzumab + Chemotherapy
- description
- Participants received placebo matched to pertuzumab IV Q3W and trastuzumab (8 mg/kg loading dose, then 6 mg/kg) IV Q3W for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 mg/m\^2 + epirubicin 90-120 mg/m\^2 or doxorubicin 50 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m\^2 for 3 cycles, 75 mg/m\^2 in first cycle and 100 mg/m\^2 in subsequent cycles, or 75 mg/m\^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m\^2 QW; 2) 4 cycles (Q3W) of doxorubicin 60 mg/m\^2 or epirubicin 90-120 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m\^2 + carboplatin AUC 6 (up to 900 mg).
- id
- OG001
- title
- Placebo + Trastuzumab + Chemotherapy
- param Type
- NUMBER
- population Description
- The overall number of participants analyzed is the ITT population. The number analyzed is the number of participants remaining at risk for an event at the time of analysis for each timepoint.
- reporting Status
- POSTED
- time Frame
- 6, 8, and 10 years
- title
- Kaplan-Meier Estimate of the Percentage of Participants Who Were IDFS Event-Free (Excluding SPNBC) at 6, 8, and 10 Years, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings
- type
- SECONDARY
- unit Of Measure
- Estimate of percentage of participants
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Preserved source evidence · Not medical advice