NCT04494425 · OUTCOME
Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Breast Module 45 (BR45) Scale Score at Week 58
Study of Trastuzumab Deruxtecan (T-DXd) vs Investigator's Choice Chemotherapy in HER2-low, Hormone Receptor Positive, Metastatic Breast Cancer · Source last updated 2026-03-04
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- score on a scale
- Interval / dispersion
- Standard Deviation
- Time frame
- Baseline (Day 1) and Week 58
What was measured
EORTC QLQ-BR45 is an updated version of the BR23. Self-administered instrument includes original 23-items yielding 5 multi-item scores (body image, sexual functioning, arm symptoms, breast symptoms, and systemic therapy side effects). Additional 22 items yield 4 additional multi-item scales (breast satisfaction, endocrine therapy symptoms, skin mucosis symptoms, and endocrine sexual symptoms). Single items assess sexual enjoyment, future perspective and being upset by hair loss. Items are scored on a 4-point verbal rating scale: 1: not at all, 2: a little, 3: quite a bit, and 4: very much; higher score: better level of functioning or greater degree of symptoms. Scores of these scales were averaged from scores of component items, transformed, and ranged from 0 to 100; higher scores for functioning scales or items indicate better functioning, whereas higher scores for symptom scales or items represent a higher level of symptoms. Baseline:last observed measurement prior to randomization.
Analysis population: The ITT population included all randomized participants. Only participants with data collected in specified categories are reported.
Groups in this outcome
T-DXd
Participants received T-DXd 5.4 mg/kg via IV infusion every 3 weeks until PD, unacceptable toxicity, withdrawal of consent, or another criterion for discontinuation was met.
Chemotherapy
Participants received Investigator's choice single-agent chemotherapy (capecitabine 1000 or 1250 mg/m\^2 orally twice daily for 2 weeks followed by a 1-week rest period in 3-week cycles, paclitaxel 80 mg/m\^2 via IV infusion qw in 3-week cycles or nab-paclitaxel 100 mg/m\^2 via IV infusion qw for 3 weeks followed by 1-week rest period in 4-week cycles) until PD, unacceptable toxicity, withdrawal of consent, or another criterion for discontinuation was 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 |
|---|
| T-DXd | 107 |
|---|
| Chemotherapy | 80 |
|---|
Reported measurements
Body Image
Analysis denominator · Participants
| Group | Source count |
|---|
| T-DXd | 107 |
|---|
| Chemotherapy | 80 |
|---|
Values in score on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| T-DXd | -3.12 | 23.585 | Not reported | Not reported | Not reported |
|---|
| Chemotherapy | -5.42 | 22.349 | Not reported | Not reported | Not reported |
|---|
Sexual Functioning
Analysis denominator · Participants
| Group | Source count |
|---|
| T-DXd | 107 |
|---|
| Chemotherapy | 80 |
|---|
Values in score on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| T-DXd | -2.96 | 12.708 | Not reported | Not reported | Not reported |
|---|
| Chemotherapy | 1.46 | 14.081 | Not reported | Not reported | Not reported |
|---|
Arm Symptoms
Analysis denominator · Participants
| Group | Source count |
|---|
| T-DXd | 107 |
|---|
| Chemotherapy | 80 |
|---|
Values in score on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| T-DXd | -5.30 | 20.496 | Not reported | Not reported | Not reported |
|---|
| Chemotherapy | -3.06 | 18.540 | Not reported | Not reported | Not reported |
|---|
Breast Symptoms
Analysis denominator · Participants
| Group | Source count |
|---|
| T-DXd | 107 |
|---|
| Chemotherapy | 80 |
|---|
Values in score on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| T-DXd | -2.41 | 17.132 | Not reported | Not reported | Not reported |
|---|
| Chemotherapy | -2.19 | 12.631 | Not reported | Not reported | Not reported |
|---|
Systemic Therapy Side Effects
Analysis denominator · Participants
| Group | Source count |
|---|
| T-DXd | 107 |
|---|
| Chemotherapy | 80 |
|---|
Values in score on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| T-DXd | 5.65 | 15.536 | Not reported | Not reported | Not reported |
|---|
| Chemotherapy | 3.99 | 15.536 | Not reported | Not reported | Not reported |
|---|
Breast Satisfaction
Analysis denominator · Participants
| Group | Source count |
|---|
| T-DXd | 107 |
|---|
| Chemotherapy | 78 |
|---|
Values in score on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| T-DXd | 2.65 | 30.982 | Not reported | Not reported | Not reported |
|---|
| Chemotherapy | 0.85 | 31.428 | Not reported | Not reported | Not reported |
|---|
Endocrine Therapy Symptoms
Analysis denominator · Participants
| Group | Source count |
|---|
| T-DXd | 107 |
|---|
| Chemotherapy | 80 |
|---|
Values in score on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| T-DXd | -0.14 | 11.316 | Not reported | Not reported | Not reported |
|---|
| Chemotherapy | 0.17 | 12.458 | Not reported | Not reported | Not reported |
|---|
Skin Mucosis Symptoms
Analysis denominator · Participants
| Group | Source count |
|---|
| T-DXd | 107 |
|---|
| Chemotherapy | 80 |
|---|
Values in score on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| T-DXd | 4.67 | 14.721 | Not reported | Not reported | Not reported |
|---|
| Chemotherapy | 12.22 | 18.232 | Not reported | Not reported | Not reported |
|---|
Endocrine Sexual Symptoms
Analysis denominator · Participants
| Group | Source count |
|---|
| T-DXd | 107 |
|---|
| Chemotherapy | 79 |
|---|
Values in score on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| T-DXd | 3.66 | 20.831 | Not reported | Not reported | Not reported |
|---|
| Chemotherapy | 2.00 | 15.969 | Not reported | Not reported | Not reported |
|---|
Sexual Enjoyment
Analysis denominator · Participants
| Group | Source count |
|---|
| T-DXd | 11 |
|---|
| Chemotherapy | 12 |
|---|
Values in score on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| T-DXd | -3.03 | 17.979 | Not reported | Not reported | Not reported |
|---|
| Chemotherapy | 0.00 | 20.101 | Not reported | Not reported | Not reported |
|---|
Future Perspective
Analysis denominator · Participants
| Group | Source count |
|---|
| T-DXd | 107 |
|---|
| Chemotherapy | 80 |
|---|
Values in score on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| T-DXd | 8.72 | 32.161 | Not reported | Not reported | Not reported |
|---|
| Chemotherapy | 11.25 | 29.022 | Not reported | Not reported | Not reported |
|---|
Being Upset By Hair Loss
Analysis denominator · Participants
| Group | Source count |
|---|
| T-DXd | 27 |
|---|
| Chemotherapy | 9 |
|---|
Values in score on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| T-DXd | 2.47 | 34.500 | Not reported | Not reported | Not reported |
|---|
| Chemotherapy | 0.00 | 40.825 | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 23.585
- value
- -3.12
- group Id
- OG001
- spread
- 22.349
- value
- -5.42
- denoms
- counts
- group Id
- OG000
- value
- 107
- group Id
- OG001
- value
- 80
- units
- Participants
- title
- Body Image
- categories
- measurements
- group Id
- OG000
- spread
- 12.708
- value
- -2.96
- group Id
- OG001
- spread
- 14.081
- value
- 1.46
- denoms
- counts
- group Id
- OG000
- value
- 107
- group Id
- OG001
- value
- 80
- units
- Participants
- title
- Sexual Functioning
- categories
- measurements
- group Id
- OG000
- spread
- 20.496
- value
- -5.30
- group Id
- OG001
- spread
- 18.540
- value
- -3.06
- denoms
- counts
- group Id
- OG000
- value
- 107
- group Id
- OG001
- value
- 80
- units
- Participants
- title
- Arm Symptoms
- categories
- measurements
- group Id
- OG000
- spread
- 17.132
- value
- -2.41
- group Id
- OG001
- spread
- 12.631
- value
- -2.19
- denoms
- counts
- group Id
- OG000
- value
- 107
- group Id
- OG001
- value
- 80
- units
- Participants
- title
- Breast Symptoms
- categories
- measurements
- group Id
- OG000
- spread
- 15.536
- value
- 5.65
- group Id
- OG001
- spread
- 15.536
- value
- 3.99
- denoms
- counts
- group Id
- OG000
- value
- 107
- group Id
- OG001
- value
- 80
- units
- Participants
- title
- Systemic Therapy Side Effects
- categories
- measurements
- group Id
- OG000
- spread
- 30.982
- value
- 2.65
- group Id
- OG001
- spread
- 31.428
- value
- 0.85
- denoms
- counts
- group Id
- OG000
- value
- 107
- group Id
- OG001
- value
- 78
- units
- Participants
- title
- Breast Satisfaction
- categories
- measurements
- group Id
- OG000
- spread
- 11.316
- value
- -0.14
- group Id
- OG001
- spread
- 12.458
- value
- 0.17
- denoms
- counts
- group Id
- OG000
- value
- 107
- group Id
- OG001
- value
- 80
- units
- Participants
- title
- Endocrine Therapy Symptoms
- categories
- measurements
- group Id
- OG000
- spread
- 14.721
- value
- 4.67
- group Id
- OG001
- spread
- 18.232
- value
- 12.22
- denoms
- counts
- group Id
- OG000
- value
- 107
- group Id
- OG001
- value
- 80
- units
- Participants
- title
- Skin Mucosis Symptoms
- categories
- measurements
- group Id
- OG000
- spread
- 20.831
- value
- 3.66
- group Id
- OG001
- spread
- 15.969
- value
- 2.00
- denoms
- counts
- group Id
- OG000
- value
- 107
- group Id
- OG001
- value
- 79
- units
- Participants
- title
- Endocrine Sexual Symptoms
- categories
- measurements
- group Id
- OG000
- spread
- 17.979
- value
- -3.03
- group Id
- OG001
- spread
- 20.101
- value
- 0.00
- denoms
- counts
- group Id
- OG000
- value
- 11
- group Id
- OG001
- value
- 12
- units
- Participants
- title
- Sexual Enjoyment
- categories
- measurements
- group Id
- OG000
- spread
- 32.161
- value
- 8.72
- group Id
- OG001
- spread
- 29.022
- value
- 11.25
- denoms
- counts
- group Id
- OG000
- value
- 107
- group Id
- OG001
- value
- 80
- units
- Participants
- title
- Future Perspective
- categories
- measurements
- group Id
- OG000
- spread
- 34.500
- value
- 2.47
- group Id
- OG001
- spread
- 40.825
- value
- 0.00
- denoms
- counts
- group Id
- OG000
- value
- 27
- group Id
- OG001
- value
- 9
- units
- Participants
- title
- Being Upset By Hair Loss
- denoms
- counts
- group Id
- OG000
- value
- 107
- group Id
- OG001
- value
- 80
- units
- Participants
- description
- EORTC QLQ-BR45 is an updated version of the BR23. Self-administered instrument includes original 23-items yielding 5 multi-item scores (body image, sexual functioning, arm symptoms, breast symptoms, and systemic therapy side effects). Additional 22 items yield 4 additional multi-item scales (breast satisfaction, endocrine therapy symptoms, skin mucosis symptoms, and endocrine sexual symptoms). Single items assess sexual enjoyment, future perspective and being upset by hair loss. Items are scored on a 4-point verbal rating scale: 1: not at all, 2: a little, 3: quite a bit, and 4: very much; higher score: better level of functioning or greater degree of symptoms. Scores of these scales were averaged from scores of component items, transformed, and ranged from 0 to 100; higher scores for functioning scales or items indicate better functioning, whereas higher scores for symptom scales or items represent a higher level of symptoms. Baseline:last observed measurement prior to randomization.
- dispersion Type
- Standard Deviation
- groups
- description
- Participants received T-DXd 5.4 mg/kg via IV infusion every 3 weeks until PD, unacceptable toxicity, withdrawal of consent, or another criterion for discontinuation was met.
- id
- OG000
- title
- T-DXd
- description
- Participants received Investigator's choice single-agent chemotherapy (capecitabine 1000 or 1250 mg/m\^2 orally twice daily for 2 weeks followed by a 1-week rest period in 3-week cycles, paclitaxel 80 mg/m\^2 via IV infusion qw in 3-week cycles or nab-paclitaxel 100 mg/m\^2 via IV infusion qw for 3 weeks followed by 1-week rest period in 4-week cycles) until PD, unacceptable toxicity, withdrawal of consent, or another criterion for discontinuation was met.
- id
- OG001
- title
- Chemotherapy
- param Type
- MEAN
- population Description
- The ITT population included all randomized participants. Only participants with data collected in specified categories are reported.
- reporting Status
- POSTED
- time Frame
- Baseline (Day 1) and Week 58
- title
- Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Breast Module 45 (BR45) Scale Score at Week 58
- type
- SECONDARY
- unit Of Measure
- score on a scale
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Preserved source evidence · Not medical advice
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