TriangleNCT01602380 · OUTCOME
Objective Response Rate (ORR) 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
- Percentage of participants
- 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
ORR was defined as the percentage patients with an objective response (i.e. those recording a partial response \[PR\] or complete response \[CR\]) at some point during the study, prior to disease progression. ORR was assessed in patients with measurable disease at baseline only. The determination of measurable disease at baseline was done using baseline RECIST data. CR was disappearance of all target lesions since baseline; was any pathological lymph nodes selected as target lesions (TL) to have a reduction in short axis to \<10 millimeter. PR was at least a 30% decrease in the sum of the diameters of TL, taking as reference the baseline sum of diameters.
Analysis population: Percentages for ORR were calculated based on the number of patients in the ITT analysis set (which included all randomised patients) who had measurable disease at baseline (n=193 for Fulvestrant arm and n=196 for Anastrozole arm).
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 | 193 |
| Anastrozole 1 mg | 196 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Fulvestrant 500 mg | 46.1 | Not reported | Not reported | Not reported | Not reported |
| Anastrozole 1 mg | 44.9 | Not reported | Not reported | Not reported | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.716
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.614
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- p Value
- 0.7290
- p Value Comment
- 2-sided p-value
- param Type
- Odds Ratio (OR)
- param Value
- 1.074
- statistical Method
- Regression, Logistic
Complete source fields
- analyses
- ci Lower Limit
- 0.716
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.614
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- p Value
- 0.7290
- p Value Comment
- 2-sided p-value
- param Type
- Odds Ratio (OR)
- param Value
- 1.074
- statistical Method
- Regression, Logistic
- classes
- categories
- measurements
- group Id
- OG000
- value
- 46.1
- group Id
- OG001
- value
- 44.9
- denoms
- counts
- group Id
- OG000
- value
- 193
- group Id
- OG001
- value
- 196
- units
- Participants
- description
- ORR was defined as the percentage patients with an objective response (i.e. those recording a partial response \[PR\] or complete response \[CR\]) at some point during the study, prior to disease progression. ORR was assessed in patients with measurable disease at baseline only. The determination of measurable disease at baseline was done using baseline RECIST data. CR was disappearance of all target lesions since baseline; was any pathological lymph nodes selected as target lesions (TL) to have a reduction in short axis to \<10 millimeter. PR was at least a 30% decrease in the sum of the diameters of TL, taking as reference the baseline sum of diameters.
- 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
- Percentages for ORR were calculated based on the number of patients in the ITT analysis set (which included all randomised patients) who had measurable disease at baseline (n=193 for Fulvestrant arm and n=196 for Anastrozole arm).
- 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
- Objective Response Rate (ORR) for Fulvestrant Treatment Versus Anastrozole Treatment
- type
- SECONDARY
- unit Of Measure
- Percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice