TriangleNCT01602380 · OUTCOME
Duration of Response (DoR) 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
- MEDIAN
- Unit
- Months
- Interval / dispersion
- Inter-Quartile Range
- 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
DoR was defined only for patients who had an objective response, as the time in days from date of first documentation of response (CR/PR) until date of disease progression. CR was disappearance of all target lesions since baseline; any pathological lymph nodes selected as TL to have a reduction in short axis to \<10 mm. At least a 30% decrease in the sum of the diameters of TL, taking as reference the baseline sum of diameters.
Analysis population: Only patients in the ITT analysis set (which included all randomised patients), who also had an objective response and had measurable disease at baseline were included in the DoR analysis (n=89 for Fulvestrant arm and n=88 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 | 89 |
| Anastrozole 1 mg | 88 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Fulvestrant 500 mg | 20.0 | Not reported | 10.6 | NA | NA = Not Available. 75th percentile value not calculable due to insufficient data. |
| Anastrozole 1 mg | 13.2 | Not reported | 8.3 | 24.7 | Not reported |
Complete source fields
- classes
- categories
- measurements
- comment
- NA = Not Available. 75th percentile value not calculable due to insufficient data.
- group Id
- OG000
- lower Limit
- 10.6
- upper Limit
- NA
- value
- 20.0
- group Id
- OG001
- lower Limit
- 8.3
- upper Limit
- 24.7
- value
- 13.2
- denoms
- counts
- group Id
- OG000
- value
- 89
- group Id
- OG001
- value
- 88
- units
- Participants
- description
- DoR was defined only for patients who had an objective response, as the time in days from date of first documentation of response (CR/PR) until date of disease progression. CR was disappearance of all target lesions since baseline; any pathological lymph nodes selected as TL to have a reduction in short axis to \<10 mm. At least a 30% decrease in the sum of the diameters of TL, taking as reference the baseline sum of diameters.
- dispersion Type
- Inter-Quartile Range
- 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
- MEDIAN
- population Description
- Only patients in the ITT analysis set (which included all randomised patients), who also had an objective response and had measurable disease at baseline were included in the DoR analysis (n=89 for Fulvestrant arm and n=88 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
- Duration of Response (DoR) for Fulvestrant Treatment Versus Anastrozole Treatment
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice