NCT02246621 · OUTCOME
Change From Baseline to End of Study in Symptom Burden on the EORTC QLQ-Breast23 Questionnaire
A Study of Nonsteroidal Aromatase Inhibitors Plus Abemaciclib (LY2835219) in Postmenopausal Women With Breast Cancer · Source last updated 2026-02-03
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- LEAST_SQUARES_MEAN
- Unit
- score on a scale
- Interval / dispersion
- Standard Error
- Time frame
- Baseline, End of Study (Up to 32 Months)
What was measured
The EORTC-QLQ-BR23 is a 23-item breast cancer-specific companion module to the EORTC-QLQ-C30 and consists of four functional scales (body image, sexual functioning, sexual enjoyment, future perspective) and four symptom scales (systemic side effects, breast symptoms, arm symptoms, upset by hair loss). QLQ-BR23 questionnaire employs 4-point scales with responses from: 1, "Not at all"; 2, "A little"; 3, "Quite a bit"; to 4, "Very much". All scores are converted to a 0 to 100 scale. A higher score representing a higher ("better") level of functioning (BR23: body image, sexual functioning, future perspective), or a higher ("worse") level of symptoms. Least Square (LS) Mean was calculated using Mixed Model Repeated Measures (MMRM) model with treatment, Visit, Treatment\*Visit and Baseline.
Analysis population: All randomized participants.
Groups in this outcome
Abemaciclib + NSAI
150 mg Abemaciclib orally every 12 hours plus either 1 mg anastrozole or 2.5 mg letrozole orally once daily for 28 days (28 day cycles).
Placebo + NSAI
Placebo orally every 12 hours plus either 1 mg anastrozole or 2.5 mg letrozole orally once daily for 28 days (28 day cycles).
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 + NSAI | 328 |
|---|
| Placebo + NSAI | 165 |
|---|
Reported measurements
Body image
Analysis denominator · Participants
| Group | Source count |
|---|
| Abemaciclib + NSAI | 328 |
|---|
| Placebo + NSAI | 165 |
|---|
Values in score on a scale · Interval/dispersion: Standard Error| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Abemaciclib + NSAI | -4.5 | 1.1 | Not reported | Not reported | Not reported |
|---|
| Placebo + NSAI | 0.6 | 1.6 | Not reported | Not reported | Not reported |
|---|
Sexual functioning
Analysis denominator · Participants
| Group | Source count |
|---|
| Abemaciclib + NSAI | 328 |
|---|
| Placebo + NSAI | 165 |
|---|
Values in score on a scale · Interval/dispersion: Standard Error| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Abemaciclib + NSAI | -0.2 | 0.7 | Not reported | Not reported | Not reported |
|---|
| Placebo + NSAI | -0.1 | 1.0 | Not reported | Not reported | Not reported |
|---|
Future perspective
Analysis denominator · Participants
| Group | Source count |
|---|
| Abemaciclib + NSAI | 328 |
|---|
| Placebo + NSAI | 165 |
|---|
Values in score on a scale · Interval/dispersion: Standard Error| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Abemaciclib + NSAI | 12.7 | 1.3 | Not reported | Not reported | Not reported |
|---|
| Placebo + NSAI | 11.9 | 1.9 | Not reported | Not reported | Not reported |
|---|
sexual enjoyment
Analysis denominator · Participants
| Group | Source count |
|---|
| Abemaciclib + NSAI | 0 |
|---|
| Placebo + NSAI | 0 |
|---|
Systemic therapy side effects
Analysis denominator · Participants
| Group | Source count |
|---|
| Abemaciclib + NSAI | 328 |
|---|
| Placebo + NSAI | 165 |
|---|
Values in score on a scale · Interval/dispersion: Standard Error| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Abemaciclib + NSAI | 8.15 | 0.68 | Not reported | Not reported | Not reported |
|---|
| Placebo + NSAI | 3.68 | 0.98 | Not reported | Not reported | Not reported |
|---|
Breast symptoms
Analysis denominator · Participants
| Group | Source count |
|---|
| Abemaciclib + NSAI | 328 |
|---|
| Placebo + NSAI | 165 |
|---|
Values in score on a scale · Interval/dispersion: Standard Error| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Abemaciclib + NSAI | -6.12 | 0.64 | Not reported | Not reported | Not reported |
|---|
| Placebo + NSAI | -6.23 | 0.93 | Not reported | Not reported | Not reported |
|---|
Arm symptoms
Analysis denominator · Participants
| Group | Source count |
|---|
| Abemaciclib + NSAI | 328 |
|---|
| Placebo + NSAI | 165 |
|---|
Values in score on a scale · Interval/dispersion: Standard Error| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Abemaciclib + NSAI | -1.14 | 0.87 | Not reported | Not reported | Not reported |
|---|
| Placebo + NSAI | -2.23 | 1.27 | Not reported | Not reported | Not reported |
|---|
upset by hair loss
Analysis denominator · Participants
| Group | Source count |
|---|
| Abemaciclib + NSAI | 0 |
|---|
| Placebo + NSAI | 0 |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 1.1
- value
- -4.5
- group Id
- OG001
- spread
- 1.6
- value
- 0.6
- denoms
- counts
- group Id
- OG000
- value
- 328
- group Id
- OG001
- value
- 165
- units
- Participants
- title
- Body image
- categories
- measurements
- group Id
- OG000
- spread
- 0.7
- value
- -0.2
- group Id
- OG001
- spread
- 1.0
- value
- -0.1
- denoms
- counts
- group Id
- OG000
- value
- 328
- group Id
- OG001
- value
- 165
- units
- Participants
- title
- Sexual functioning
- categories
- measurements
- group Id
- OG000
- spread
- 1.3
- value
- 12.7
- group Id
- OG001
- spread
- 1.9
- value
- 11.9
- denoms
- counts
- group Id
- OG000
- value
- 328
- group Id
- OG001
- value
- 165
- units
- Participants
- title
- Future perspective
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- units
- Participants
- title
- sexual enjoyment
- categories
- measurements
- group Id
- OG000
- spread
- 0.68
- value
- 8.15
- group Id
- OG001
- spread
- 0.98
- value
- 3.68
- denoms
- counts
- group Id
- OG000
- value
- 328
- group Id
- OG001
- value
- 165
- units
- Participants
- title
- Systemic therapy side effects
- categories
- measurements
- group Id
- OG000
- spread
- 0.64
- value
- -6.12
- group Id
- OG001
- spread
- 0.93
- value
- -6.23
- denoms
- counts
- group Id
- OG000
- value
- 328
- group Id
- OG001
- value
- 165
- units
- Participants
- title
- Breast symptoms
- categories
- measurements
- group Id
- OG000
- spread
- 0.87
- value
- -1.14
- group Id
- OG001
- spread
- 1.27
- value
- -2.23
- denoms
- counts
- group Id
- OG000
- value
- 328
- group Id
- OG001
- value
- 165
- units
- Participants
- title
- Arm symptoms
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- units
- Participants
- title
- upset by hair loss
- denoms
- counts
- group Id
- OG000
- value
- 328
- group Id
- OG001
- value
- 165
- units
- Participants
- description
- The EORTC-QLQ-BR23 is a 23-item breast cancer-specific companion module to the EORTC-QLQ-C30 and consists of four functional scales (body image, sexual functioning, sexual enjoyment, future perspective) and four symptom scales (systemic side effects, breast symptoms, arm symptoms, upset by hair loss). QLQ-BR23 questionnaire employs 4-point scales with responses from: 1, "Not at all"; 2, "A little"; 3, "Quite a bit"; to 4, "Very much". All scores are converted to a 0 to 100 scale. A higher score representing a higher ("better") level of functioning (BR23: body image, sexual functioning, future perspective), or a higher ("worse") level of symptoms. Least Square (LS) Mean was calculated using Mixed Model Repeated Measures (MMRM) model with treatment, Visit, Treatment\*Visit and Baseline.
- dispersion Type
- Standard Error
- groups
- description
- 150 mg Abemaciclib orally every 12 hours plus either 1 mg anastrozole or 2.5 mg letrozole orally once daily for 28 days (28 day cycles).
- id
- OG000
- title
- Abemaciclib + NSAI
- description
- Placebo orally every 12 hours plus either 1 mg anastrozole or 2.5 mg letrozole orally once daily for 28 days (28 day cycles).
- id
- OG001
- title
- Placebo + NSAI
- param Type
- LEAST_SQUARES_MEAN
- population Description
- All randomized participants.
- reporting Status
- POSTED
- time Frame
- Baseline, End of Study (Up to 32 Months)
- title
- Change From Baseline to End of Study in Symptom Burden on the EORTC QLQ-Breast23 Questionnaire
- type
- SECONDARY
- unit Of Measure
- score on a scale
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