TriangleNCT00045032 · OUTCOME
DDFS Rate According to Kaplan-Meier Analysis in 1-Year Versus 2-Year Herceptin: 8-Year Median Follow-Up
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
- Years 3, 5, 7, 8
What was measured
DDFS events included distant tumor recurrence, second primary cancer, or contralateral breast cancer. The percentage of participants free of DDFS events (i.e., the DDFS rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the 8-year median follow-up analysis.
Analysis population: FAS Population 1Y2Y
Groups in this outcome
Herceptin 1-Year Arm
Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
Herceptin 2-Year Arm
Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
| Group | Source count |
|---|---|
| Herceptin 1-Year Arm | 1552 |
| Herceptin 2-Year Arm | 1553 |
Reported measurements
Year 3
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Herceptin 1-Year Arm | 89.4 | Not reported | 87.9 | 91.0 | Not reported |
| Herceptin 2-Year Arm | 90.8 | Not reported | 89.4 | 92.2 | Not reported |
Year 5
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Herceptin 1-Year Arm | 84.5 | Not reported | 82.7 | 86.3 | Not reported |
| Herceptin 2-Year Arm | 84.7 | Not reported | 82.9 | 86.5 | Not reported |
Year 7
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Herceptin 1-Year Arm | 81.4 | Not reported | 79.5 | 83.4 | Not reported |
| Herceptin 2-Year Arm | 81.1 | Not reported | 79.1 | 83.1 | Not reported |
Year 8
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Herceptin 1-Year Arm | 80.1 | Not reported | 78.1 | 82.2 | Not reported |
| Herceptin 2-Year Arm | 79.9 | Not reported | 77.8 | 81.9 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 87.9
- upper Limit
- 91.0
- value
- 89.4
- group Id
- OG001
- lower Limit
- 89.4
- upper Limit
- 92.2
- value
- 90.8
- title
- Year 3
- categories
- measurements
- group Id
- OG000
- lower Limit
- 82.7
- upper Limit
- 86.3
- value
- 84.5
- group Id
- OG001
- lower Limit
- 82.9
- upper Limit
- 86.5
- value
- 84.7
- title
- Year 5
- categories
- measurements
- group Id
- OG000
- lower Limit
- 79.5
- upper Limit
- 83.4
- value
- 81.4
- group Id
- OG001
- lower Limit
- 79.1
- upper Limit
- 83.1
- value
- 81.1
- title
- Year 7
- categories
- measurements
- group Id
- OG000
- lower Limit
- 78.1
- upper Limit
- 82.2
- value
- 80.1
- group Id
- OG001
- lower Limit
- 77.8
- upper Limit
- 81.9
- value
- 79.9
- title
- Year 8
- denoms
- counts
- group Id
- OG000
- value
- 1552
- group Id
- OG001
- value
- 1553
- units
- Participants
- description
- DDFS events included distant tumor recurrence, second primary cancer, or contralateral breast cancer. The percentage of participants free of DDFS events (i.e., the DDFS rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the 8-year median follow-up analysis.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
- id
- OG000
- title
- Herceptin 1-Year Arm
- description
- Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
- id
- OG001
- title
- Herceptin 2-Year Arm
- param Type
- NUMBER
- population Description
- FAS Population 1Y2Y
- reporting Status
- POSTED
- time Frame
- Years 3, 5, 7, 8
- title
- DDFS Rate According to Kaplan-Meier Analysis in 1-Year Versus 2-Year Herceptin: 8-Year Median Follow-Up
- type
- SECONDARY
- unit Of Measure
- percentage of participants
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Preserved source evidence · Not medical advice