TriangleNCT01631552 · OUTCOME
Objective Response Rate by Local Assessment
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
- Up to data cutoff date of 01 March 2019 (maximum duration: 74 months)
What was measured
ORR was defined as the rate an overall best response of either complete response (CR) or partial response (PR) by local assessment. CR was defined as the disappearance of all target lesions and reduction in short axis of any pathologic lymphnode to \<10 mm. PR was defined as ≥3 0% decrease in the sum of diameters of target lesions, taking the baseline sum diameters. Per planned analysis, ORR by Local Assessment was assessed for TNBC Target Population, HR+/HER2-mBC Population, and mUC Population.
Analysis population: * Target mTNBC: Participants with mTNBC who received at least 2 prior therapies for metastatic disease \& who received at least 1 dose of 10 mg/kg SG * HR+/HER2-mBC: Participants with HR+/HER2- mBC who progressed on at least 1 prior hormonal therapy \& who received at least 1 dose of 10 mg/kg SG * mUC: Participants who had relapsed after or were refractory to at least 1 prior treatments \& who received at least 1 dose of 10 mg/kg SG
Groups in this outcome
TNBC Target Population
Overall 144 participants with TNBC were enrolled in the study and received at least one dose of SG. Of these 144 participants, 108 received at least 2 prior therapies for metastatic disease and were treated with SG at a starting dose of 10mg/kg. These 108 participants were included in the analysis of safety and were referred to as the TNBC Target Population.
HR+/HER2- mBC Population
Overall 68 participants with non-TNBC were enrolled in the study and received at least one dose of SG. Of these 68 participants, 54 were confirmed as HR+/HER2-, had progressed on at least one prior hormonal therapy in the metastatic setting, and had received at least one dose of 10 mg/kg SG. These 54 participants were included in the analysis of safety and were referred to as the HR+/HER2- mBC Population.
mUC Population
Overall 49 participants with metastatic urothelial cancer were enrolled in the study and received at least one dose of SG. Of these 49 participants, 45 had either relapsed after or were refractory to at least one prior standard therapeutic regimen and received at least one dose of 10 mg/kg SG. These 45 participants were included in the analysis of safety and were referred to as the mUC Population.
| Group | Source count |
|---|---|
| TNBC Target Population | 108 |
| HR+/HER2- mBC Population | 54 |
| mUC Population | 45 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| TNBC Target Population | 33.3 | Not reported | 24.6 | 43.1 | Not reported |
| HR+/HER2- mBC Population | 31.5 | Not reported | 19.5 | 45.6 | Not reported |
| mUC Population | 28.9 | Not reported | 16.4 | 44.3 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 24.6
- upper Limit
- 43.1
- value
- 33.3
- group Id
- OG001
- lower Limit
- 19.5
- upper Limit
- 45.6
- value
- 31.5
- group Id
- OG002
- lower Limit
- 16.4
- upper Limit
- 44.3
- value
- 28.9
- denoms
- counts
- group Id
- OG000
- value
- 108
- group Id
- OG001
- value
- 54
- group Id
- OG002
- value
- 45
- units
- Participants
- description
- ORR was defined as the rate an overall best response of either complete response (CR) or partial response (PR) by local assessment. CR was defined as the disappearance of all target lesions and reduction in short axis of any pathologic lymphnode to \<10 mm. PR was defined as ≥3 0% decrease in the sum of diameters of target lesions, taking the baseline sum diameters. Per planned analysis, ORR by Local Assessment was assessed for TNBC Target Population, HR+/HER2-mBC Population, and mUC Population.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Overall 144 participants with TNBC were enrolled in the study and received at least one dose of SG. Of these 144 participants, 108 received at least 2 prior therapies for metastatic disease and were treated with SG at a starting dose of 10mg/kg. These 108 participants were included in the analysis of safety and were referred to as the TNBC Target Population.
- id
- OG000
- title
- TNBC Target Population
- description
- Overall 68 participants with non-TNBC were enrolled in the study and received at least one dose of SG. Of these 68 participants, 54 were confirmed as HR+/HER2-, had progressed on at least one prior hormonal therapy in the metastatic setting, and had received at least one dose of 10 mg/kg SG. These 54 participants were included in the analysis of safety and were referred to as the HR+/HER2- mBC Population.
- id
- OG001
- title
- HR+/HER2- mBC Population
- description
- Overall 49 participants with metastatic urothelial cancer were enrolled in the study and received at least one dose of SG. Of these 49 participants, 45 had either relapsed after or were refractory to at least one prior standard therapeutic regimen and received at least one dose of 10 mg/kg SG. These 45 participants were included in the analysis of safety and were referred to as the mUC Population.
- id
- OG002
- title
- mUC Population
- param Type
- NUMBER
- population Description
- * Target mTNBC: Participants with mTNBC who received at least 2 prior therapies for metastatic disease \& who received at least 1 dose of 10 mg/kg SG * HR+/HER2-mBC: Participants with HR+/HER2- mBC who progressed on at least 1 prior hormonal therapy \& who received at least 1 dose of 10 mg/kg SG * mUC: Participants who had relapsed after or were refractory to at least 1 prior treatments \& who received at least 1 dose of 10 mg/kg SG
- reporting Status
- POSTED
- time Frame
- Up to data cutoff date of 01 March 2019 (maximum duration: 74 months)
- title
- Objective Response Rate by Local Assessment
- type
- PRIMARY
- unit Of Measure
- Percentage of participants
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Preserved source evidence · Not medical advice