TriangleNCT02952534 · OUTCOME
Clinical Benefit Rate (CBR) by Gene Per Central Independent Radiology Review (IRR)
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
- Assessments every 8 weeks from study day 1 for the first 24 weeks, and then every 12 weeks until disease progression, death, or initiation of subsequent treatment. Total follow-up was up to approximately 3 years.
What was measured
A secondary efficacy endpoint is Clinical Benefit Rate (CBR) assessed by IRR. CBR is defined as the number of patients without radiographic progression (defined by modified RECIST Version 1.1/ PCWG3 criteria) who were continuing with study drug treatment through the given time interval divided by the number of patients who had the given amount of follow-up. Clinical benefit rates are summarized at 6 and 12 months.
Analysis population: All patients
Groups in this outcome
BRCA Mutation
Patients with a deleterious BRCA (breast cancer susceptibility gene) mutation detected in their tumor.
ATM Mutation
Patients with a deleterious ATM (ataxia telangiectasia mutated serine/threonine kinase) mutation detected in their tumor.
CDK12 Mutation
Patients with a deleterious CDK12 (Cyclin-dependent kinase 12) mutation detected in their tumor.
CHEK2 Mutation
Patients with a deleterious CHEK2 (Checkpoint Kinase 2) mutation detected in their tumor.
Other Gene Mutation
Patients with other deleterious HRR (homologous recombination repair) gene mutation detected in their tumor.
| Group | Source count |
|---|---|
| BRCA Mutation | 172 |
| ATM Mutation | 59 |
| CDK12 Mutation | 14 |
| CHEK2 Mutation | 7 |
| Other Gene Mutation | 25 |
Reported measurements
6 months
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| BRCA Mutation | 100 | Not reported | Not reported | Not reported | Not reported |
| ATM Mutation | 10 | Not reported | Not reported | Not reported | Not reported |
| CDK12 Mutation | 2 | Not reported | Not reported | Not reported | Not reported |
| CHEK2 Mutation | 2 | Not reported | Not reported | Not reported | Not reported |
| Other Gene Mutation | 13 | Not reported | Not reported | Not reported | Not reported |
12 months
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| BRCA Mutation | 36 | Not reported | Not reported | Not reported | Not reported |
| ATM Mutation | 3 | Not reported | Not reported | Not reported | Not reported |
| CDK12 Mutation | 0 | Not reported | Not reported | Not reported | Not reported |
| CHEK2 Mutation | 1 | Not reported | Not reported | Not reported | Not reported |
| Other Gene Mutation | 6 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 100
- group Id
- OG001
- value
- 10
- group Id
- OG002
- value
- 2
- group Id
- OG003
- value
- 2
- group Id
- OG004
- value
- 13
- title
- 6 months
- categories
- measurements
- group Id
- OG000
- value
- 36
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 6
- title
- 12 months
- denoms
- counts
- group Id
- OG000
- value
- 172
- group Id
- OG001
- value
- 59
- group Id
- OG002
- value
- 14
- group Id
- OG003
- value
- 7
- group Id
- OG004
- value
- 25
- units
- Participants
- description
- A secondary efficacy endpoint is Clinical Benefit Rate (CBR) assessed by IRR. CBR is defined as the number of patients without radiographic progression (defined by modified RECIST Version 1.1/ PCWG3 criteria) who were continuing with study drug treatment through the given time interval divided by the number of patients who had the given amount of follow-up. Clinical benefit rates are summarized at 6 and 12 months.
- groups
- description
- Patients with a deleterious BRCA (breast cancer susceptibility gene) mutation detected in their tumor.
- id
- OG000
- title
- BRCA Mutation
- description
- Patients with a deleterious ATM (ataxia telangiectasia mutated serine/threonine kinase) mutation detected in their tumor.
- id
- OG001
- title
- ATM Mutation
- description
- Patients with a deleterious CDK12 (Cyclin-dependent kinase 12) mutation detected in their tumor.
- id
- OG002
- title
- CDK12 Mutation
- description
- Patients with a deleterious CHEK2 (Checkpoint Kinase 2) mutation detected in their tumor.
- id
- OG003
- title
- CHEK2 Mutation
- description
- Patients with other deleterious HRR (homologous recombination repair) gene mutation detected in their tumor.
- id
- OG004
- title
- Other Gene Mutation
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- All patients
- reporting Status
- POSTED
- time Frame
- Assessments every 8 weeks from study day 1 for the first 24 weeks, and then every 12 weeks until disease progression, death, or initiation of subsequent treatment. Total follow-up was up to approximately 3 years.
- title
- Clinical Benefit Rate (CBR) by Gene Per Central Independent Radiology Review (IRR)
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice