TriangleNCT01602380 · OUTCOME
Expected Duration of Clinical Benefit (EDoCB) for Fulvestrant Treatment Versus Anastrozole Treatment
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Days
- Interval / dispersion
- Not reported
- Time frame
- Baseline RECIST 1.1 assessments (Day 0) and then every 12 weeks until disease progression or treatment discontinuation (up to approximately 38 months)
What was measured
EDoCB was estimated using the formula EDoCB = p Efp(x), where x = EDoCB, p = proportion of responders, and Efp(x) = mean duration of response for responders. The estimation was completed by using the maximum likelihood estimates of p and Efp(x), as described by Ellis (Ellis S et al. Analysis of duration of response in oncology trials, Contemp Clin Trials 2008; 29:456-65).
Analysis population: The ITT analysis set included all randomised patients.
Groups in this outcome
Fulvestrant 500 mg
Patients received fulvestrant (Faslodex™) 500 mg, administered as two 5 mL intramuscular injections, 1 in each buttock, at each visit on Days 0, 14 (±3), 28 (±3) and every 28 (±3) days thereafter. In order to support the double-blind, double-dummy design of the trial, each patient randomised to receive fulvestrant, also received placebo to match the anastrozole schedule (tablets, once daily).
Anastrozole 1 mg
Patients received anastrozole (Arimidex™), administered orally as a single tablet at a dose of 1 mg/day from randomisation on Day 0 and once daily thereafter. In order to support the double-blind, double-dummy design of the trial, each patient randomised to receive anastrozole also received placebo to match the fulvestrant schedule (injections on Days 0, 14 \[±3\], 28 \[±3\] and every 28 \[±3\] days thereafter).
| Group | Source count |
|---|---|
| Fulvestrant 500 mg | 230 |
| Anastrozole 1 mg | 232 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Fulvestrant 500 mg | 667.94 | Not reported | Not reported | Not reported | Not reported |
| Anastrozole 1 mg | 532.04 | Not reported | Not reported | Not reported | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.99
- ci Pct Value
- 95
- ci Upper Limit
- 1.59
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- p Value
- 0.0561
- p Value Comment
- 2-sided p-value
- param Type
- Ratio of EDoCB
- param Value
- 1.26
- statistical Method
- Method of Ellis et al
Complete source fields
- analyses
- ci Lower Limit
- 0.99
- ci Pct Value
- 95
- ci Upper Limit
- 1.59
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- p Value
- 0.0561
- p Value Comment
- 2-sided p-value
- param Type
- Ratio of EDoCB
- param Value
- 1.26
- statistical Method
- Method of Ellis et al
- classes
- categories
- measurements
- group Id
- OG000
- value
- 667.94
- group Id
- OG001
- value
- 532.04
- denoms
- counts
- group Id
- OG000
- value
- 230
- group Id
- OG001
- value
- 232
- units
- Participants
- description
- EDoCB was estimated using the formula EDoCB = p Efp(x), where x = EDoCB, p = proportion of responders, and Efp(x) = mean duration of response for responders. The estimation was completed by using the maximum likelihood estimates of p and Efp(x), as described by Ellis (Ellis S et al. Analysis of duration of response in oncology trials, Contemp Clin Trials 2008; 29:456-65).
- groups
- description
- Patients received fulvestrant (Faslodex™) 500 mg, administered as two 5 mL intramuscular injections, 1 in each buttock, at each visit on Days 0, 14 (±3), 28 (±3) and every 28 (±3) days thereafter. In order to support the double-blind, double-dummy design of the trial, each patient randomised to receive fulvestrant, also received placebo to match the anastrozole schedule (tablets, once daily).
- id
- OG000
- title
- Fulvestrant 500 mg
- description
- Patients received anastrozole (Arimidex™), administered orally as a single tablet at a dose of 1 mg/day from randomisation on Day 0 and once daily thereafter. In order to support the double-blind, double-dummy design of the trial, each patient randomised to receive anastrozole also received placebo to match the fulvestrant schedule (injections on Days 0, 14 \[±3\], 28 \[±3\] and every 28 \[±3\] days thereafter).
- id
- OG001
- title
- Anastrozole 1 mg
- param Type
- NUMBER
- population Description
- The ITT analysis set included all randomised patients.
- reporting Status
- POSTED
- time Frame
- Baseline RECIST 1.1 assessments (Day 0) and then every 12 weeks until disease progression or treatment discontinuation (up to approximately 38 months)
- title
- Expected Duration of Clinical Benefit (EDoCB) for Fulvestrant Treatment Versus Anastrozole Treatment
- type
- SECONDARY
- unit Of Measure
- Days
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice