TriangleNCT01602380 · OUTCOME
Comparison of the Effect of Fulvestrant Treatment Versus Anastrozole Treatment on Time to Deterioration of Health-Related Quality of Life (HRQoL)
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
- Quality of life questionnaires administered at 3 months post objective disease progression, then at 6-monthly intervals (approximately 75 months)
What was measured
The Functional Assessment of Cancer Therapy - Breast (FACT-B) questionnaire was the instrument selected to assess HRQoL and comprised of following subscales: physical well-being (PWB), functional well-being (FWB), social well-being, emotional well-being, and breast cancer subscale (BCS). The main outcome measure from the FACT-B questionnaire was the Trial Outcome Index (TOI), which was a summary of the following subscales: PWB, FWB, and BCS. Outcome measure is reported as median time to deterioration, defined as the interval from the date of baseline of final analysis to the first assessment of worsened without an improvement in the next 12 weeks in FACT-B TOI, or the date of death (by any cause in the absence of symptom deterioration). Time to deterioration as measured by FACT-B total score was derived similarly and is also reported.
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
Time to TOI deterioration
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Fulvestrant 500 mg | 14.1 | Not reported | 5.5 | 44.1 | Not reported |
| Anastrozole 1 mg | 11.1 | Not reported | 5.5 | 38.3 | Not reported |
Time to FACT-B total score deterioration
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Fulvestrant 500 mg | 13.8 | Not reported | 5.5 | 38.7 | Not reported |
| Anastrozole 1 mg | 11.1 | Not reported | 4.8 | 33.6 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.70
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.11
- estimate Comment
- A hazard ratio \< 1 favours fulvestrant.
- group Description
- Comparative statistical analysis for time to deterioration of TOI score is presented (fulvestrant versus anastrozole).
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- p Value
- 0.2846
- p Value Comment
- 2-sided p-value
- param Type
- Hazard Ratio (HR)
- param Value
- 0.88
- statistical Comment
- Stratified log-rank test with factors for prior chemotherapy for locally advanced/metastatic disease and measurable/non-measurable disease at baseline
- statistical Method
- Log Rank
- ci Lower Limit
- 0.66
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.03
- estimate Comment
- A hazard ratio \< 1 favours fulvestrant.
- group Description
- Comparative statistical analysis for time to deterioration of FACT-B total score is presented (fulvestrant versus anastrozole).
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- p Value
- 0.0844
- p Value Comment
- 2-sided p-value
- param Type
- Hazard Ratio (HR)
- param Value
- 0.82
- statistical Comment
- Stratified log-rank test with factors for prior chemotherapy for locally advanced/metastatic disease and measurable/non-measurable disease at baseline
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.70
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.11
- estimate Comment
- A hazard ratio \< 1 favours fulvestrant.
- group Description
- Comparative statistical analysis for time to deterioration of TOI score is presented (fulvestrant versus anastrozole).
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- p Value
- 0.2846
- p Value Comment
- 2-sided p-value
- param Type
- Hazard Ratio (HR)
- param Value
- 0.88
- statistical Comment
- Stratified log-rank test with factors for prior chemotherapy for locally advanced/metastatic disease and measurable/non-measurable disease at baseline
- statistical Method
- Log Rank
- ci Lower Limit
- 0.66
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.03
- estimate Comment
- A hazard ratio \< 1 favours fulvestrant.
- group Description
- Comparative statistical analysis for time to deterioration of FACT-B total score is presented (fulvestrant versus anastrozole).
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- p Value
- 0.0844
- p Value Comment
- 2-sided p-value
- param Type
- Hazard Ratio (HR)
- param Value
- 0.82
- statistical Comment
- Stratified log-rank test with factors for prior chemotherapy for locally advanced/metastatic disease and measurable/non-measurable disease at baseline
- statistical Method
- Log Rank
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 5.5
- upper Limit
- 44.1
- value
- 14.1
- group Id
- OG001
- lower Limit
- 5.5
- upper Limit
- 38.3
- value
- 11.1
- title
- Time to TOI deterioration
- categories
- measurements
- group Id
- OG000
- lower Limit
- 5.5
- upper Limit
- 38.7
- value
- 13.8
- group Id
- OG001
- lower Limit
- 4.8
- upper Limit
- 33.6
- value
- 11.1
- title
- Time to FACT-B total score deterioration
- denoms
- counts
- group Id
- OG000
- value
- 230
- group Id
- OG001
- value
- 232
- units
- Participants
- description
- The Functional Assessment of Cancer Therapy - Breast (FACT-B) questionnaire was the instrument selected to assess HRQoL and comprised of following subscales: physical well-being (PWB), functional well-being (FWB), social well-being, emotional well-being, and breast cancer subscale (BCS). The main outcome measure from the FACT-B questionnaire was the Trial Outcome Index (TOI), which was a summary of the following subscales: PWB, FWB, and BCS. Outcome measure is reported as median time to deterioration, defined as the interval from the date of baseline of final analysis to the first assessment of worsened without an improvement in the next 12 weeks in FACT-B TOI, or the date of death (by any cause in the absence of symptom deterioration). Time to deterioration as measured by FACT-B total score was derived similarly and is also reported.
- 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
- The ITT analysis set included all randomised patients.
- reporting Status
- POSTED
- time Frame
- Quality of life questionnaires administered at 3 months post objective disease progression, then at 6-monthly intervals (approximately 75 months)
- title
- Comparison of the Effect of Fulvestrant Treatment Versus Anastrozole Treatment on Time to Deterioration of Health-Related Quality of Life (HRQoL)
- type
- SECONDARY
- unit Of Measure
- months
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Preserved source evidence · Not medical advice