NCT04494425 · OUTCOME
Objective Response Rate Assessed by Blinded Independent Central Review and Investigator in the Intent-to-Treat and Human Epidermal Growth Factor Receptor 2 Immunohistochemistry >0 <1+ Population
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
- NUMBER
- Unit
- percentage of participants
- Interval / dispersion
- Not reported
- Time frame
- Response evaluations performed at screening, q6w ± 1 week from randomization for 48 weeks, and then q9w ± 1 week, starting at Week 48 until PD, up to PCD of 18 March 2024 (maximum of approximately 43.85 months)
What was measured
ORR per RECIST 1.1 assessed by BICR and Investigator was defined as the percentage of participants with at least 1 visit response of CR or PR. CR was defined as disappearance of all TLs since baseline. Any pathological lymph nodes selected as TLs must have a reduction in short axis diameter to \<10 mm. PR was defined as at least a 30% decrease in the sum of the diameters of TL, taking as reference the baseline sum of diameters.
Analysis population: The ITT population included all randomized participants. The HER2 IHC \>0 \<1+ population included subset of participants included in ITT population with HER2 IHC \>0 \<1+ as determined by central laboratory testing and who have had at least 24 weeks of follow-up at time of interim futility PCD. 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 | 436 |
|---|
| Chemotherapy | 430 |
|---|
Reported measurements
BICR Assessment: ITT Population
Analysis denominator · Participants
| Group | Source count |
|---|
| T-DXd | 436 |
|---|
| Chemotherapy | 430 |
|---|
Values in percentage of participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| T-DXd | 61.5 | Not reported | Not reported | Not reported | Not reported |
|---|
| Chemotherapy | 36.7 | Not reported | Not reported | Not reported | Not reported |
|---|
Investigator Assessment: ITT Population
Analysis denominator · Participants
| Group | Source count |
|---|
| T-DXd | 436 |
|---|
| Chemotherapy | 430 |
|---|
Values in percentage of participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| T-DXd | 61.5 | Not reported | Not reported | Not reported | Not reported |
|---|
| Chemotherapy | 38.8 | Not reported | Not reported | Not reported | Not reported |
|---|
BICR Assessment: HER2 IHC >0 <1+ Population
Analysis denominator · Participants
| Group | Source count |
|---|
| T-DXd | 76 |
|---|
| Chemotherapy | 76 |
|---|
Values in percentage of participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| T-DXd | 67.1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Chemotherapy | 31.6 | Not reported | Not reported | Not reported | Not reported |
|---|
Investigator Assessment: HER2 IHC >0 <1+ Population
Analysis denominator · Participants
| Group | Source count |
|---|
| T-DXd | 76 |
|---|
| Chemotherapy | 76 |
|---|
Values in percentage of participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| T-DXd | 65.8 | Not reported | Not reported | Not reported | Not reported |
|---|
| Chemotherapy | 31.6 | Not reported | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 61.5
- group Id
- OG001
- value
- 36.7
- denoms
- counts
- group Id
- OG000
- value
- 436
- group Id
- OG001
- value
- 430
- units
- Participants
- title
- BICR Assessment: ITT Population
- categories
- measurements
- group Id
- OG000
- value
- 61.5
- group Id
- OG001
- value
- 38.8
- denoms
- counts
- group Id
- OG000
- value
- 436
- group Id
- OG001
- value
- 430
- units
- Participants
- title
- Investigator Assessment: ITT Population
- categories
- measurements
- group Id
- OG000
- value
- 67.1
- group Id
- OG001
- value
- 31.6
- denoms
- counts
- group Id
- OG000
- value
- 76
- group Id
- OG001
- value
- 76
- units
- Participants
- title
- BICR Assessment: HER2 IHC >0 <1+ Population
- categories
- measurements
- group Id
- OG000
- value
- 65.8
- group Id
- OG001
- value
- 31.6
- denoms
- counts
- group Id
- OG000
- value
- 76
- group Id
- OG001
- value
- 76
- units
- Participants
- title
- Investigator Assessment: HER2 IHC >0 <1+ Population
- denoms
- counts
- group Id
- OG000
- value
- 436
- group Id
- OG001
- value
- 430
- units
- Participants
- description
- ORR per RECIST 1.1 assessed by BICR and Investigator was defined as the percentage of participants with at least 1 visit response of CR or PR. CR was defined as disappearance of all TLs since baseline. Any pathological lymph nodes selected as TLs must have a reduction in short axis diameter to \<10 mm. PR was defined as at least a 30% decrease in the sum of the diameters of TL, taking as reference the baseline sum of diameters.
- 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
- NUMBER
- population Description
- The ITT population included all randomized participants. The HER2 IHC \>0 \<1+ population included subset of participants included in ITT population with HER2 IHC \>0 \<1+ as determined by central laboratory testing and who have had at least 24 weeks of follow-up at time of interim futility PCD. Only participants with data collected in specified categories are reported.
- reporting Status
- POSTED
- time Frame
- Response evaluations performed at screening, q6w ± 1 week from randomization for 48 weeks, and then q9w ± 1 week, starting at Week 48 until PD, up to PCD of 18 March 2024 (maximum of approximately 43.85 months)
- title
- Objective Response Rate Assessed by Blinded Independent Central Review and Investigator in the Intent-to-Treat and Human Epidermal Growth Factor Receptor 2 Immunohistochemistry >0 <1+ Population
- type
- SECONDARY
- unit Of Measure
- percentage of participants
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