TriangleNCT03523585 · OUTCOME
Percentage of Participants With Objective Response Rate (ORR) in Participants With HER2-positive, Unresectable and/or Metastatic Breast Cancer Participants Previously Treated With Trastuzumab Emtansine
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
- 95% Confidence Interval
- Time frame
- Baseline up to 46 months postdose
What was measured
The Objective Response Rate (ORR) was defined as the percentage of participants who achieved a best overall response of confirmed Complete Response (CR) or Partial Response (PR), assessed by BICR and investigator assessment based on RECIST version 1.1. CR was defined as a disappearance of all target lesions and PR was defined as at least a 30% decrease in the sum of diameters of target lesions. Confirmed ORR based on BICR and Investigator Assessment is reported.
Analysis population: Objective response rate (ORR) was assessed in the Full Analysis Set at data cut-off date of 30 Jun 2022.
Groups in this outcome
Trastuzumab Deruxtecan (T-DXd)
Participants with HER2 positive, unresectable and/or metastatic breast cancer participants previously treated with standard of care HER2 therapies, including ado-trastuzumab emtansine (T-DM1), who received T-DXd as a sterile intravenous (IV) solution at a dose of 5.4 mg/kg every 3 weeks (Q3W).
Treatment of Investigator's/Physician's Choice (TPC)
Participants with HER2 positive, unresectable and/or metastatic breast cancer participants previously treated with standard of care HER2 therapies, including ado-trastuzumab emtansine (T-DM1), who received investigator's choice treatment, Trastuzumab/Capecitabine or Lapatinib/Capecitabine.
| Group | Source count |
|---|---|
| Trastuzumab Deruxtecan (T-DXd) | 406 |
| Treatment of Investigator's/Physician's Choice (TPC) | 202 |
Reported measurements
BICR
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Trastuzumab Deruxtecan (T-DXd) | 69.7 | Not reported | 65.0 | 74.1 | Not reported |
| Treatment of Investigator's/Physician's Choice (TPC) | 29.2 | Not reported | 23.0 | 36.0 | Not reported |
Investigator Assessment
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Trastuzumab Deruxtecan (T-DXd) | 74.1 | Not reported | 69.6 | 78.3 | Not reported |
| Treatment of Investigator's/Physician's Choice (TPC) | 26.7 | Not reported | 20.8 | 33.4 | Not reported |
Source statistical analyses
- group Description
- Statistical Analysis for BICR Assessment
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- <0.0001
- p Value Comment
- Cochran-Mantel-Haenszel test adjusted for stratification factors: hormone receptor status, prior treatment with pertuzumab, and history of visceral disease, as defined by the IXRS.
- statistical Method
- Cochran-Mantel-Haenszel
- group Description
- Statistical Analysis for Investigator Assessment
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- <0.0001
- p Value Comment
- Cochran-Mantel-Haenszel test adjusted for stratification factors: hormone receptor status, prior treatment with pertuzumab, and history of visceral disease, as defined by the IXRS.
- statistical Method
- Cochran-Mantel-Haenszel
Complete source fields
- analyses
- group Description
- Statistical Analysis for BICR Assessment
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- <0.0001
- p Value Comment
- Cochran-Mantel-Haenszel test adjusted for stratification factors: hormone receptor status, prior treatment with pertuzumab, and history of visceral disease, as defined by the IXRS.
- statistical Method
- Cochran-Mantel-Haenszel
- group Description
- Statistical Analysis for Investigator Assessment
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- <0.0001
- p Value Comment
- Cochran-Mantel-Haenszel test adjusted for stratification factors: hormone receptor status, prior treatment with pertuzumab, and history of visceral disease, as defined by the IXRS.
- statistical Method
- Cochran-Mantel-Haenszel
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 65.0
- upper Limit
- 74.1
- value
- 69.7
- group Id
- OG001
- lower Limit
- 23.0
- upper Limit
- 36.0
- value
- 29.2
- title
- BICR
- categories
- measurements
- group Id
- OG000
- lower Limit
- 69.6
- upper Limit
- 78.3
- value
- 74.1
- group Id
- OG001
- lower Limit
- 20.8
- upper Limit
- 33.4
- value
- 26.7
- title
- Investigator Assessment
- denoms
- counts
- group Id
- OG000
- value
- 406
- group Id
- OG001
- value
- 202
- units
- Participants
- description
- The Objective Response Rate (ORR) was defined as the percentage of participants who achieved a best overall response of confirmed Complete Response (CR) or Partial Response (PR), assessed by BICR and investigator assessment based on RECIST version 1.1. CR was defined as a disappearance of all target lesions and PR was defined as at least a 30% decrease in the sum of diameters of target lesions. Confirmed ORR based on BICR and Investigator Assessment is reported.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants with HER2 positive, unresectable and/or metastatic breast cancer participants previously treated with standard of care HER2 therapies, including ado-trastuzumab emtansine (T-DM1), who received T-DXd as a sterile intravenous (IV) solution at a dose of 5.4 mg/kg every 3 weeks (Q3W).
- id
- OG000
- title
- Trastuzumab Deruxtecan (T-DXd)
- description
- Participants with HER2 positive, unresectable and/or metastatic breast cancer participants previously treated with standard of care HER2 therapies, including ado-trastuzumab emtansine (T-DM1), who received investigator's choice treatment, Trastuzumab/Capecitabine or Lapatinib/Capecitabine.
- id
- OG001
- title
- Treatment of Investigator's/Physician's Choice (TPC)
- param Type
- NUMBER
- population Description
- Objective response rate (ORR) was assessed in the Full Analysis Set at data cut-off date of 30 Jun 2022.
- reporting Status
- POSTED
- time Frame
- Baseline up to 46 months postdose
- title
- Percentage of Participants With Objective Response Rate (ORR) in Participants With HER2-positive, Unresectable and/or Metastatic Breast Cancer Participants Previously Treated With Trastuzumab Emtansine
- type
- SECONDARY
- unit Of Measure
- Percentage of Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice