NCT03734029 · OUTCOME
Best Overall Response and Confirmed Objective Response Rate (ORR) in the Hormone Receptor-Positive Cohort in Participants With HER2-low Breast Cancer
Trastuzumab Deruxtecan (DS-8201a) Versus Investigator's Choice for HER2-low Breast Cancer That Has Spread or Cannot be Surgically Removed [DESTINY-Breast04] · Source last updated 2025-10-06
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- From screening and every 6 weeks up to withdrawal of subject consent, progressive disease (PD), or unacceptable toxicity, up to approximately 3 years
What was measured
Best overall response rate and confirmed objective response rate (ORR) were assessed by blinded independent central review (BICR) and investigator assessment. Complete response (CR) was defined as a disappearance of all target lesions, partial response (PR) was defined as at least a 30% decrease in the sum of diameters of target lesions, and stable disease (SD) was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD; at least a 20% increase in the sum of diameters of target lesions. Confirmed ORR was defined as the number of participants with complete and partial responses and confirmed by a second assessment.
Analysis population: Best overall response and confirmed objective response rate were assessed in the Hormone Receptor-Positive cohort of Full Analysis Set.
Groups in this outcome
Trastuzumab Deruxtecan (T-DXd)
Participants with HER2-low, unresectable, and/or metastatic breast cancer who were previously treated with chemotherapy were randomized to receive an intravenous infusion of DS8201a (initial dose of 5.4 mg/kg) over approximately 90 minutes. If there was no infusion-related reaction (IRR), T-DXd doses after the initial dose of 5.4 mg/kg were infused over a minimum of 30 minutes.
Physician's Choice
Participants with HER2-low, unresectable, and/or metastatic breast cancer who were previously treated with chemotherapy and randomized to a physician's choice (capecitabine, eribulin, gemcitabine, paclitaxel, and nab-paclitaxel) in which the dose, regimen, administration, and dose modification followed the label approved in the country of drug administration or the National Comprehensive Cancer Network guidelines.
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 |
|---|
| Trastuzumab Deruxtecan (T-DXd) | 331 |
|---|
| Physician's Choice | 163 |
|---|
Reported measurements
BICR: Complete response
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Trastuzumab Deruxtecan (T-DXd) | 12 | Not reported | Not reported | Not reported | Not reported |
|---|
| Physician's Choice | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
BICR: Partial response
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Trastuzumab Deruxtecan (T-DXd) | 164 | Not reported | Not reported | Not reported | Not reported |
|---|
| Physician's Choice | 26 | Not reported | Not reported | Not reported | Not reported |
|---|
BICR: Stable disease
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Trastuzumab Deruxtecan (T-DXd) | 115 | Not reported | Not reported | Not reported | Not reported |
|---|
| Physician's Choice | 81 | Not reported | Not reported | Not reported | Not reported |
|---|
BICR: Progressive disease
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Trastuzumab Deruxtecan (T-DXd) | 26 | Not reported | Not reported | Not reported | Not reported |
|---|
| Physician's Choice | 34 | Not reported | Not reported | Not reported | Not reported |
|---|
BICR: Not evaluable
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Trastuzumab Deruxtecan (T-DXd) | 14 | Not reported | Not reported | Not reported | Not reported |
|---|
| Physician's Choice | 21 | Not reported | Not reported | Not reported | Not reported |
|---|
Investigator: Complete response
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Trastuzumab Deruxtecan (T-DXd) | 5 | Not reported | Not reported | Not reported | Not reported |
|---|
| Physician's Choice | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Investigator: Partial response
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Trastuzumab Deruxtecan (T-DXd) | 163 | Not reported | Not reported | Not reported | Not reported |
|---|
| Physician's Choice | 30 | Not reported | Not reported | Not reported | Not reported |
|---|
Investigator: Stable disease
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Trastuzumab Deruxtecan (T-DXd) | 124 | Not reported | Not reported | Not reported | Not reported |
|---|
| Physician's Choice | 80 | Not reported | Not reported | Not reported | Not reported |
|---|
Investigator: Progressive disease
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Trastuzumab Deruxtecan (T-DXd) | 28 | Not reported | Not reported | Not reported | Not reported |
|---|
| Physician's Choice | 34 | Not reported | Not reported | Not reported | Not reported |
|---|
Investigator: Not evaluable
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Trastuzumab Deruxtecan (T-DXd) | 11 | Not reported | Not reported | Not reported | Not reported |
|---|
| Physician's Choice | 19 | Not reported | Not reported | Not reported | Not reported |
|---|
BICR: Confirmed Objective response rate
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Trastuzumab Deruxtecan (T-DXd) | 175 | Not reported | Not reported | Not reported | Not reported |
|---|
| Physician's Choice | 27 | Not reported | Not reported | Not reported | Not reported |
|---|
Investigator: Confirmed Objective response rate
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Trastuzumab Deruxtecan (T-DXd) | 168 | Not reported | Not reported | Not reported | Not reported |
|---|
| Physician's Choice | 30 | Not reported | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 12
- group Id
- OG001
- value
- 1
- title
- BICR: Complete response
- categories
- measurements
- group Id
- OG000
- value
- 164
- group Id
- OG001
- value
- 26
- title
- BICR: Partial response
- categories
- measurements
- group Id
- OG000
- value
- 115
- group Id
- OG001
- value
- 81
- title
- BICR: Stable disease
- categories
- measurements
- group Id
- OG000
- value
- 26
- group Id
- OG001
- value
- 34
- title
- BICR: Progressive disease
- categories
- measurements
- group Id
- OG000
- value
- 14
- group Id
- OG001
- value
- 21
- title
- BICR: Not evaluable
- categories
- measurements
- group Id
- OG000
- value
- 5
- group Id
- OG001
- value
- 0
- title
- Investigator: Complete response
- categories
- measurements
- group Id
- OG000
- value
- 163
- group Id
- OG001
- value
- 30
- title
- Investigator: Partial response
- categories
- measurements
- group Id
- OG000
- value
- 124
- group Id
- OG001
- value
- 80
- title
- Investigator: Stable disease
- categories
- measurements
- group Id
- OG000
- value
- 28
- group Id
- OG001
- value
- 34
- title
- Investigator: Progressive disease
- categories
- measurements
- group Id
- OG000
- value
- 11
- group Id
- OG001
- value
- 19
- title
- Investigator: Not evaluable
- categories
- measurements
- group Id
- OG000
- value
- 175
- group Id
- OG001
- value
- 27
- title
- BICR: Confirmed Objective response rate
- categories
- measurements
- group Id
- OG000
- value
- 168
- group Id
- OG001
- value
- 30
- title
- Investigator: Confirmed Objective response rate
- denoms
- counts
- group Id
- OG000
- value
- 331
- group Id
- OG001
- value
- 163
- units
- Participants
- description
- Best overall response rate and confirmed objective response rate (ORR) were assessed by blinded independent central review (BICR) and investigator assessment. Complete response (CR) was defined as a disappearance of all target lesions, partial response (PR) was defined as at least a 30% decrease in the sum of diameters of target lesions, and stable disease (SD) was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD; at least a 20% increase in the sum of diameters of target lesions. Confirmed ORR was defined as the number of participants with complete and partial responses and confirmed by a second assessment.
- groups
- description
- Participants with HER2-low, unresectable, and/or metastatic breast cancer who were previously treated with chemotherapy were randomized to receive an intravenous infusion of DS8201a (initial dose of 5.4 mg/kg) over approximately 90 minutes. If there was no infusion-related reaction (IRR), T-DXd doses after the initial dose of 5.4 mg/kg were infused over a minimum of 30 minutes.
- id
- OG000
- title
- Trastuzumab Deruxtecan (T-DXd)
- description
- Participants with HER2-low, unresectable, and/or metastatic breast cancer who were previously treated with chemotherapy and randomized to a physician's choice (capecitabine, eribulin, gemcitabine, paclitaxel, and nab-paclitaxel) in which the dose, regimen, administration, and dose modification followed the label approved in the country of drug administration or the National Comprehensive Cancer Network guidelines.
- id
- OG001
- title
- Physician's Choice
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Best overall response and confirmed objective response rate were assessed in the Hormone Receptor-Positive cohort of Full Analysis Set.
- reporting Status
- POSTED
- time Frame
- From screening and every 6 weeks up to withdrawal of subject consent, progressive disease (PD), or unacceptable toxicity, up to approximately 3 years
- title
- Best Overall Response and Confirmed Objective Response Rate (ORR) in the Hormone Receptor-Positive Cohort in Participants With HER2-low Breast Cancer
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice
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