TriangleNCT02952534 · OUTCOME
Clinical Benefit Rate (CBR) by Gene Per Investigator
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 Investigator. 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 | 103 | Not reported | Not reported | Not reported | Not reported |
| ATM Mutation | 17 | Not reported | Not reported | Not reported | Not reported |
| CDK12 Mutation | 3 | Not reported | Not reported | Not reported | Not reported |
| CHEK2 Mutation | 2 | Not reported | Not reported | Not reported | Not reported |
| Other Gene Mutation | 14 | Not reported | Not reported | Not reported | Not reported |
12 months
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| BRCA Mutation | 39 | Not reported | Not reported | Not reported | Not reported |
| ATM Mutation | 6 | Not reported | Not reported | Not reported | Not reported |
| CDK12 Mutation | 1 | 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
- 103
- group Id
- OG001
- value
- 17
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 2
- group Id
- OG004
- value
- 14
- title
- 6 months
- categories
- measurements
- group Id
- OG000
- value
- 39
- group Id
- OG001
- value
- 6
- group Id
- OG002
- value
- 1
- 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 Investigator. 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 Investigator
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice