TriangleNCT00021255 · OUTCOME
Percentage of Participants With Disease Free Survival at 5 Years
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
- From randomization until relapse or death or up to 5 years
What was measured
Disease Free Survival was defined as the interval from the date of randomization to the date of local, regional or metastatic relapse or the date of second primary cancer (with the exception of curatively treated non-melanoma skin cancer or in situ carcinoma of the cervix) or death from any cause whichever occured first. Disease free survival was estimated using the Kaplan-Meier method.
Analysis population: ITT population.
Groups in this outcome
Doxorubicin+Cyclophosphamide (AC) Followed by Docetaxel (AC→T)
Doxorubicin 60 mg/m² IV bolus injection in combination with cyclophosphamide 600 mg/m² IV bolus injection on Day 1 of every 3 weeks for 4 cycles followed by docetaxel 100 mg/m² IV infusion every 3 weeks for another 4 cycles.
AC Followed by Docetaxel + Herceptin (AC→TH)
Doxorubicin 60 mg/m² IV bolus injection in combination with cyclophosphamide 600 mg/m² IV bolus Injection on Day 1 of every 3 weeks for 4 cycles. Herceptin 4 mg/kg IV infusion on Day 1 of Cycle 5, followed by Herceptin 2 mg/kg by IV infusion weekly starting from Day 8; and docetaxel 100 mg/m² IV infusion on Day 2 of Cycle 5, then on Day 1 of every 3 weeks for all subsequent cycles ( total 4 cycles). After completion of the last cycle of chemotherapy, Herceptin 6 mg/kg IV infusion was administered every 3 weeks until 1 year from date of initial Herceptin dose.
Docetaxel + Carboplatin + Herceptin (TCH)
Herceptin 4 mg/kg IV infusion on Day 1 of Cycle 1 only, followed by Herceptin 2 mg/kg IV infusion weekly starting from Day 8 until three weeks after the last cycle of chemotherapy. Docetaxel 75 mg/ m² IV infusion on Day 2 of Cycle 1, then on Day 1 of all subsequent cycles followed by carboplatin IV infusion at target AUC = 6 mg/mL/min repeated every 3 weeks for a total of 6 cycles. After completion of the last cycle of chemotherapy, Herceptin 6 mg/kg by IV infusion was administered every 3 weeks until 1 year from date of initial Herceptin dose.
| Group | Source count |
|---|---|
| Doxorubicin+Cyclophosphamide (AC) Followed by Docetaxel (AC→T) | 1073 |
| AC Followed by Docetaxel + Herceptin (AC→TH) | 1074 |
| Docetaxel + Carboplatin + Herceptin (TCH) | 1075 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Doxorubicin+Cyclophosphamide (AC) Followed by Docetaxel (AC→T) | 75.5 | Not reported | 72.8 | 78.2 | Not reported |
| AC Followed by Docetaxel + Herceptin (AC→TH) | 83.2 | Not reported | 80.9 | 85.4 | Not reported |
| Docetaxel + Carboplatin + Herceptin (TCH) | 81.0 | Not reported | 78.6 | 83.4 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 72.8
- upper Limit
- 78.2
- value
- 75.5
- group Id
- OG001
- lower Limit
- 80.9
- upper Limit
- 85.4
- value
- 83.2
- group Id
- OG002
- lower Limit
- 78.6
- upper Limit
- 83.4
- value
- 81.0
- denoms
- counts
- group Id
- OG000
- value
- 1073
- group Id
- OG001
- value
- 1074
- group Id
- OG002
- value
- 1075
- units
- Participants
- description
- Disease Free Survival was defined as the interval from the date of randomization to the date of local, regional or metastatic relapse or the date of second primary cancer (with the exception of curatively treated non-melanoma skin cancer or in situ carcinoma of the cervix) or death from any cause whichever occured first. Disease free survival was estimated using the Kaplan-Meier method.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Doxorubicin 60 mg/m² IV bolus injection in combination with cyclophosphamide 600 mg/m² IV bolus injection on Day 1 of every 3 weeks for 4 cycles followed by docetaxel 100 mg/m² IV infusion every 3 weeks for another 4 cycles.
- id
- OG000
- title
- Doxorubicin+Cyclophosphamide (AC) Followed by Docetaxel (AC→T)
- description
- Doxorubicin 60 mg/m² IV bolus injection in combination with cyclophosphamide 600 mg/m² IV bolus Injection on Day 1 of every 3 weeks for 4 cycles. Herceptin 4 mg/kg IV infusion on Day 1 of Cycle 5, followed by Herceptin 2 mg/kg by IV infusion weekly starting from Day 8; and docetaxel 100 mg/m² IV infusion on Day 2 of Cycle 5, then on Day 1 of every 3 weeks for all subsequent cycles ( total 4 cycles). After completion of the last cycle of chemotherapy, Herceptin 6 mg/kg IV infusion was administered every 3 weeks until 1 year from date of initial Herceptin dose.
- id
- OG001
- title
- AC Followed by Docetaxel + Herceptin (AC→TH)
- description
- Herceptin 4 mg/kg IV infusion on Day 1 of Cycle 1 only, followed by Herceptin 2 mg/kg IV infusion weekly starting from Day 8 until three weeks after the last cycle of chemotherapy. Docetaxel 75 mg/ m² IV infusion on Day 2 of Cycle 1, then on Day 1 of all subsequent cycles followed by carboplatin IV infusion at target AUC = 6 mg/mL/min repeated every 3 weeks for a total of 6 cycles. After completion of the last cycle of chemotherapy, Herceptin 6 mg/kg by IV infusion was administered every 3 weeks until 1 year from date of initial Herceptin dose.
- id
- OG002
- title
- Docetaxel + Carboplatin + Herceptin (TCH)
- param Type
- NUMBER
- population Description
- ITT population.
- reporting Status
- POSTED
- time Frame
- From randomization until relapse or death or up to 5 years
- title
- Percentage of Participants With Disease Free Survival at 5 Years
- type
- PRIMARY
- unit Of Measure
- percentage of participants
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Preserved source evidence · Not medical advice