TriangleNCT00602043 · OUTCOME
Best Overall Response
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- patients with progressive disease
- Interval / dispersion
- Not reported
- Time frame
- Up to 6 months
What was measured
Patients were expected to start endocrine therapy within 2 weeks of the FES PET scan. Response assessment was evaluated at 3 and 6 months. For patients with at least one site of measurable disease \[per response evaluation criteria in solid tumors (RECIST, version 1.1)\], size-based response criteria were used to assess response. For patients without disease evaluable by RECIST 1.1, largely patients with bone-dominant metastatic breast cancer, serial FDG PET scanning was used to determine response. A decline in the FDG PET SUV (standard uptake value) of 30% or more was considered as response and an increase of 20% or more was considered to be progressive disease (PD). The initial (baseline) FES uptake was compared to clinical benefit (PD versus other outcome at 6 months).
Groups in this outcome
Diagnostic FES: Average FES SUVmean >1.5, no Negative Sites
Patients undergo \[\^18F\] FES PET scan. Patients also undergo standard clinical fludeoxyglucose F 18 (FDG)-PET or FDG-PET/CT scan up to 14 days prior to \[\^18F\] FES PET scan. Patients begin clinically indicated endocrine therapy. Patients are followed-up to determine response on the therapy for 6 months using clinical exams, tumor marker assays, conventional imaging and standard clinical FDG PET/CT. This group represents patients who had positive FES uptake at all disease sites on the baseline diagnostic FES PET scan. laboratory biomarker analysis: Correlative studies
Diagnostic FES: Patients With FES Negative Sites of Disease
Patients undergo \[\^18F\] FES PET scan. Patients also undergo standard clinical fludeoxyglucose F 18 (FDG)-PET or FDG-PET/CT scan up to 14 days prior to \[\^18F\] FES PET scan. Patients begin clinically indicated endocrine therapy. Patients are followed-up to determine response on the therapy for 6 months using clinical exams, tumor marker assays, conventional imaging and standard clinical FDG PET/CT. This group represents patients who had some or all disease sites negative for FES uptake on the baseline diagnostic FES PET scan.
| Group | Source count |
|---|---|
| Diagnostic FES: Average FES SUVmean >1.5, no Negative Sites | 13 |
| Diagnostic FES: Patients With FES Negative Sites of Disease | 3 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Diagnostic FES: Average FES SUVmean >1.5, no Negative Sites | 5 | Not reported | Not reported | Not reported | Not reported |
| Diagnostic FES: Patients With FES Negative Sites of Disease | 2 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 5
- group Id
- OG001
- value
- 2
- denoms
- counts
- group Id
- OG000
- value
- 13
- group Id
- OG001
- value
- 3
- units
- Participants
- description
- Patients were expected to start endocrine therapy within 2 weeks of the FES PET scan. Response assessment was evaluated at 3 and 6 months. For patients with at least one site of measurable disease \[per response evaluation criteria in solid tumors (RECIST, version 1.1)\], size-based response criteria were used to assess response. For patients without disease evaluable by RECIST 1.1, largely patients with bone-dominant metastatic breast cancer, serial FDG PET scanning was used to determine response. A decline in the FDG PET SUV (standard uptake value) of 30% or more was considered as response and an increase of 20% or more was considered to be progressive disease (PD). The initial (baseline) FES uptake was compared to clinical benefit (PD versus other outcome at 6 months).
- groups
- description
- Patients undergo \[\^18F\] FES PET scan. Patients also undergo standard clinical fludeoxyglucose F 18 (FDG)-PET or FDG-PET/CT scan up to 14 days prior to \[\^18F\] FES PET scan. Patients begin clinically indicated endocrine therapy. Patients are followed-up to determine response on the therapy for 6 months using clinical exams, tumor marker assays, conventional imaging and standard clinical FDG PET/CT. This group represents patients who had positive FES uptake at all disease sites on the baseline diagnostic FES PET scan. laboratory biomarker analysis: Correlative studies
- id
- OG000
- title
- Diagnostic FES: Average FES SUVmean >1.5, no Negative Sites
- description
- Patients undergo \[\^18F\] FES PET scan. Patients also undergo standard clinical fludeoxyglucose F 18 (FDG)-PET or FDG-PET/CT scan up to 14 days prior to \[\^18F\] FES PET scan. Patients begin clinically indicated endocrine therapy. Patients are followed-up to determine response on the therapy for 6 months using clinical exams, tumor marker assays, conventional imaging and standard clinical FDG PET/CT. This group represents patients who had some or all disease sites negative for FES uptake on the baseline diagnostic FES PET scan.
- id
- OG001
- title
- Diagnostic FES: Patients With FES Negative Sites of Disease
- param Type
- NUMBER
- reporting Status
- POSTED
- time Frame
- Up to 6 months
- title
- Best Overall Response
- type
- PRIMARY
- unit Of Measure
- patients with progressive disease
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice