TriangleNCT00045032 · OUTCOME
Percentage of Participants With DFS Events in 1-Year Versus 2-Year Herceptin: 10-Year Maximum 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
- Not reported
- Time frame
- From Baseline until time of event (maximum of 10 years)
What was measured
DFS events included loco-regional or distant recurrence of breast cancer, development of contralateral breast cancer or second non-breast malignancy other than basal or squamous carcinoma of the skin and carcinoma in situ of the cervix, or death from any cause. The percentage of participants with at least one DFS event was reported.
Analysis population: FAS Population 1-Year Herceptin Versus 2-Year Herceptin (1Y2Y): Participants without a DFS event and still under follow-up at the pre-defined landmark of 366 days after randomization, analyzed when intent-to-treat principle was applied for comparison of 1 year versus 2 years of Herceptin.
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
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Herceptin 1-Year Arm | 25.8 | Not reported | Not reported | Not reported | Not reported |
| Herceptin 2-Year Arm | 26.6 | Not reported | Not reported | Not reported | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.89
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.17
- estimate Comment
- HR for Herceptin 2-Year Arm versus Herceptin 1-Year Arm.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.7962
- param Type
- Hazard Ratio (HR)
- param Value
- 1.02
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.89
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.17
- estimate Comment
- HR for Herceptin 2-Year Arm versus Herceptin 1-Year Arm.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.7962
- param Type
- Hazard Ratio (HR)
- param Value
- 1.02
- statistical Method
- Log Rank
- classes
- categories
- measurements
- group Id
- OG000
- value
- 25.8
- group Id
- OG001
- value
- 26.6
- denoms
- counts
- group Id
- OG000
- value
- 1552
- group Id
- OG001
- value
- 1553
- units
- Participants
- description
- DFS events included loco-regional or distant recurrence of breast cancer, development of contralateral breast cancer or second non-breast malignancy other than basal or squamous carcinoma of the skin and carcinoma in situ of the cervix, or death from any cause. The percentage of participants with at least one DFS event was reported.
- 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 1-Year Herceptin Versus 2-Year Herceptin (1Y2Y): Participants without a DFS event and still under follow-up at the pre-defined landmark of 366 days after randomization, analyzed when intent-to-treat principle was applied for comparison of 1 year versus 2 years of Herceptin.
- reporting Status
- POSTED
- time Frame
- From Baseline until time of event (maximum of 10 years)
- title
- Percentage of Participants With DFS Events in 1-Year Versus 2-Year Herceptin: 10-Year Maximum Follow-Up
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice