NCT02107703 · OUTCOME
Change From Baseline to Short Term Follow up in Quality of Life Using the EORTC QLQ-BR23 (Breast) Questionnaire
A Study of Abemaciclib (LY2835219) Combined With Fulvestrant in Women With Hormone Receptor Positive HER2 Negative Breast Cancer · Source last updated 2025-10-21
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- LEAST_SQUARES_MEAN
- Unit
- Units on a scale
- Interval / dispersion
- Standard Error
- Time frame
- Baseline, Short Term Follow Up (Up To 31 Months)
What was measured
EORTC-QLQ-BR23 measured multi-item functional scales for body image, sexual functioning and future perspective and measured single item symptoms scales which assessed systemic therapy side effects, breast symptoms and arm symptoms. For functional scales, scores ranged from 0 to 100 where higher scores represented a better level of functioning. For symptoms scales, scores ranged from 0 to 100 where higher scores represented a greater degree of symptoms. LS Mean value of changing from baseline to short follow up was estimated from the mixed model that was controlled for Treatment, visit, Treatment\*Visit and baseline.
Analysis population: All randomized participants who received at least one dose of study drug with baseline and post-baseline EORTC QLQ-BR23 data at short term follow up for each BR23 items.
Groups in this outcome
Abemaciclib + Fulvestrant
Abemaciclib 150 mg administered orally every 12 hours on Days 1 to 28 of a 28-day cycle in combination with fulvestrant 500mg administered IM on Days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond. Participants received treatment until discontinuation were met.
Placebo + Fulvestrant
Placebo administered orally every 12 hours on Days 1 to 28 of a 28-day cycle in combination with fulvestrant 500mg administered IM on Days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond. Participants received treatment until discontinuation were met.
Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
| Group | Source count |
|---|
| Abemaciclib + Fulvestrant | 182 |
|---|
| Placebo + Fulvestrant | 126 |
|---|
Reported measurements
Functional scale: Body image
Analysis denominator · Participants
| Group | Source count |
|---|
| Abemaciclib + Fulvestrant | 179 |
|---|
| Placebo + Fulvestrant | 125 |
|---|
Values in Units on a scale · Interval/dispersion: Standard Error| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Abemaciclib + Fulvestrant | -2.20 | 1.46 | Not reported | Not reported | Not reported |
|---|
| Placebo + Fulvestrant | -3.27 | 1.83 | Not reported | Not reported | Not reported |
|---|
Functional scale:Sexual functioning
Analysis denominator · Participants
| Group | Source count |
|---|
| Abemaciclib + Fulvestrant | 171 |
|---|
| Placebo + Fulvestrant | 116 |
|---|
Values in Units on a scale · Interval/dispersion: Standard Error| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Abemaciclib + Fulvestrant | 0.41 | 1.00 | Not reported | Not reported | Not reported |
|---|
| Placebo + Fulvestrant | -1.60 | 1.25 | Not reported | Not reported | Not reported |
|---|
Functional scale: Future perspective
Analysis denominator · Participants
| Group | Source count |
|---|
| Abemaciclib + Fulvestrant | 179 |
|---|
| Placebo + Fulvestrant | 126 |
|---|
Values in Units on a scale · Interval/dispersion: Standard Error| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Abemaciclib + Fulvestrant | 6.06 | 2.06 | Not reported | Not reported | Not reported |
|---|
| Placebo + Fulvestrant | 10.05 | 2.51 | Not reported | Not reported | Not reported |
|---|
Symptom scale: Systemic therapy side effects
Analysis denominator · Participants
| Group | Source count |
|---|
| Abemaciclib + Fulvestrant | 182 |
|---|
| Placebo + Fulvestrant | 125 |
|---|
Values in Units on a scale · Interval/dispersion: Standard Error| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Abemaciclib + Fulvestrant | 7.23 | 1.00 | Not reported | Not reported | Not reported |
|---|
| Placebo + Fulvestrant | 6.98 | 1.22 | Not reported | Not reported | Not reported |
|---|
Symptom scale: Breast symptoms
Analysis denominator · Participants
| Group | Source count |
|---|
| Abemaciclib + Fulvestrant | 181 |
|---|
| Placebo + Fulvestrant | 126 |
|---|
Values in Units on a scale · Interval/dispersion: Standard Error| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Abemaciclib + Fulvestrant | -2.10 | 0.89 | Not reported | Not reported | Not reported |
|---|
| Placebo + Fulvestrant | -0.96 | 1.09 | Not reported | Not reported | Not reported |
|---|
Symptom scale: Arm symptoms
Analysis denominator · Participants
| Group | Source count |
|---|
| Abemaciclib + Fulvestrant | 182 |
|---|
| Placebo + Fulvestrant | 125 |
|---|
Values in Units on a scale · Interval/dispersion: Standard Error| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Abemaciclib + Fulvestrant | -0.45 | 1.29 | Not reported | Not reported | Not reported |
|---|
| Placebo + Fulvestrant | 0.10 | 1.59 | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 1.46
- value
- -2.20
- group Id
- OG001
- spread
- 1.83
- value
- -3.27
- denoms
- counts
- group Id
- OG000
- value
- 179
- group Id
- OG001
- value
- 125
- units
- Participants
- title
- Functional scale: Body image
- categories
- measurements
- group Id
- OG000
- spread
- 1.00
- value
- 0.41
- group Id
- OG001
- spread
- 1.25
- value
- -1.60
- denoms
- counts
- group Id
- OG000
- value
- 171
- group Id
- OG001
- value
- 116
- units
- Participants
- title
- Functional scale:Sexual functioning
- categories
- measurements
- group Id
- OG000
- spread
- 2.06
- value
- 6.06
- group Id
- OG001
- spread
- 2.51
- value
- 10.05
- denoms
- counts
- group Id
- OG000
- value
- 179
- group Id
- OG001
- value
- 126
- units
- Participants
- title
- Functional scale: Future perspective
- categories
- measurements
- group Id
- OG000
- spread
- 1.00
- value
- 7.23
- group Id
- OG001
- spread
- 1.22
- value
- 6.98
- denoms
- counts
- group Id
- OG000
- value
- 182
- group Id
- OG001
- value
- 125
- units
- Participants
- title
- Symptom scale: Systemic therapy side effects
- categories
- measurements
- group Id
- OG000
- spread
- 0.89
- value
- -2.10
- group Id
- OG001
- spread
- 1.09
- value
- -0.96
- denoms
- counts
- group Id
- OG000
- value
- 181
- group Id
- OG001
- value
- 126
- units
- Participants
- title
- Symptom scale: Breast symptoms
- categories
- measurements
- group Id
- OG000
- spread
- 1.29
- value
- -0.45
- group Id
- OG001
- spread
- 1.59
- value
- 0.10
- denoms
- counts
- group Id
- OG000
- value
- 182
- group Id
- OG001
- value
- 125
- units
- Participants
- title
- Symptom scale: Arm symptoms
- denoms
- counts
- group Id
- OG000
- value
- 182
- group Id
- OG001
- value
- 126
- units
- Participants
- description
- EORTC-QLQ-BR23 measured multi-item functional scales for body image, sexual functioning and future perspective and measured single item symptoms scales which assessed systemic therapy side effects, breast symptoms and arm symptoms. For functional scales, scores ranged from 0 to 100 where higher scores represented a better level of functioning. For symptoms scales, scores ranged from 0 to 100 where higher scores represented a greater degree of symptoms. LS Mean value of changing from baseline to short follow up was estimated from the mixed model that was controlled for Treatment, visit, Treatment\*Visit and baseline.
- dispersion Type
- Standard Error
- groups
- description
- Abemaciclib 150 mg administered orally every 12 hours on Days 1 to 28 of a 28-day cycle in combination with fulvestrant 500mg administered IM on Days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond. Participants received treatment until discontinuation were met.
- id
- OG000
- title
- Abemaciclib + Fulvestrant
- description
- Placebo administered orally every 12 hours on Days 1 to 28 of a 28-day cycle in combination with fulvestrant 500mg administered IM on Days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond. Participants received treatment until discontinuation were met.
- id
- OG001
- title
- Placebo + Fulvestrant
- param Type
- LEAST_SQUARES_MEAN
- population Description
- All randomized participants who received at least one dose of study drug with baseline and post-baseline EORTC QLQ-BR23 data at short term follow up for each BR23 items.
- reporting Status
- POSTED
- time Frame
- Baseline, Short Term Follow Up (Up To 31 Months)
- title
- Change From Baseline to Short Term Follow up in Quality of Life Using the EORTC QLQ-BR23 (Breast) Questionnaire
- type
- SECONDARY
- unit Of Measure
- Units on a scale
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Preserved source evidence · Not medical advice
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