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← XELODA: metastatic Breast cancer after prior therapy

NCT00602043 · STUDY IN CONTEXT

F-18 16 Alpha-Fluoroestradiol-Labeled Positron Emission Tomography in Predicting Response to First-Line Hormone Therapy in Patients With Stage IV Breast Cancer

Draft scope assessment: unclear. Attached because the study's own record describes metastatic disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full. Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

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).

Source null

→

secondary · POSTED

FES SUV prior to endocrine treatment (dichotomized and as a continuous predictor) will also be tested as predictor of clinical benefit. Patients were expected to start endocrine therapy within 2 weeks of the FES PET scan. Response assessment was evaluated at 3 and 6 months. The initial (baseline) FES uptake was compared to clinical benefit (PD versus other outcome at 6 months).

Source null

→

secondary · POSTED

FES SUV prior to endocrine treatment (dichotomized and as a continuous predictor) will also be tested as predictor of time to progression. Analysis will be conducted using (respectively) logistic regression and Cox proportional hazards regression. This will include univariate analysis of FES and other predictive measures (ER/PgR expression, serum sex steroid levels), followed by an exploratory multivariate analysis combining FES SUV with other measures showing predictive capability univariate analysis.

Source null

→

secondary · POSTED

Graphical and numerical studies of bivariate relationships will be examined, as well as factors (i.e., tumor size, tumor location, patient age) to explain concurrence, lack of concurrence, and sources of measurement error for measurements of ER function.

Data were not collected due to variations in reporting methods for ER assays.

→

Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

FACT · Correlation of FES Uptake With ER Assays

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-xeloda-717c98d4
nct id
NCT00602043
qol key
qol-0003
source section id
NCT00602043-om-0003
source outcome index
3
instrument
FACT
instrument basis
matched 'factors' in the study's own wording
scale title
Correlation of FES Uptake With ER Assays
measure definition
Graphical and numerical studies of bivariate relationships will be examined, as well as factors (i.e., tumor size, tumor location, patient age) to explain concurrence, lack of concurrence, and sources of measurement error for measurements of ER function.
time frame
Up to 6 months
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
Data were not collected due to variations in reporting methods for ER assays.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
Open the exact result →
Full draft applicability and source-link record
trial
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-xeloda-717c98d4
nct id
NCT00602043
trial label
F-18 16 Alpha-Fluoroestradiol-Labeled Positron Emission Tomography in Predicting Response to First-Line Hormone Therapy in Patients With Stage IV Breast Cancer
applicability
unclear
applicability note
Attached because the study's own record describes metastatic disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
provenance class
regulator-cited
discovery note
Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
outcome Count
4
harms Count
1
qol Count
1
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer-xeloda-717c98d4
    nct id
    NCT00602043
    outcome key
    om-0000
    source section id
    NCT00602043-om-0000
    source outcome index
    0
    endpoint
    Best Overall Response
    endpoint definition
    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).
    time origin
    Up to 6 months
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer-xeloda-717c98d4
    nct id
    NCT00602043
    outcome key
    om-0001
    source section id
    NCT00602043-om-0001
    source outcome index
    1
    endpoint
    Number of Participants With Clinical Benefit
    endpoint definition
    FES SUV prior to endocrine treatment (dichotomized and as a continuous predictor) will also be tested as predictor of clinical benefit. Patients were expected to start endocrine therapy within 2 weeks of the FES PET scan. Response assessment was evaluated at 3 and 6 months. The initial (baseline) FES uptake was compared to clinical benefit (PD versus other outcome at 6 months).
    time origin
    Up to 6 months
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer-xeloda-717c98d4
    nct id
    NCT00602043
    outcome key
    om-0002
    source section id
    NCT00602043-om-0002
    source outcome index
    2
    endpoint
    Time to Progression
    endpoint definition
    FES SUV prior to endocrine treatment (dichotomized and as a continuous predictor) will also be tested as predictor of time to progression. Analysis will be conducted using (respectively) logistic regression and Cox proportional hazards regression. This will include univariate analysis of FES and other predictive measures (ER/PgR expression, serum sex steroid levels), followed by an exploratory multivariate analysis combining FES SUV with other measures showing predictive capability univariate analysis.
    time origin
    Up to 6 months
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer-xeloda-717c98d4
    nct id
    NCT00602043
    outcome key
    om-0003
    source section id
    NCT00602043-om-0003
    source outcome index
    3
    endpoint
    Correlation of FES Uptake With ER Assays
    endpoint definition
    Graphical and numerical studies of bivariate relationships will be examined, as well as factors (i.e., tumor size, tumor location, patient age) to explain concurrence, lack of concurrence, and sources of measurement error for measurements of ER function.
    time origin
    Up to 6 months
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Data were not collected due to variations in reporting methods for ER assays.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
arms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer-xeloda-717c98d4
    nct id
    NCT00602043
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Diagnostic FES: Average FES SUVmean >1.5, no Negative Sites
    regimen
    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
    analyzed count
    13
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00602043-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer-xeloda-717c98d4
    nct id
    NCT00602043
    outcome key
    om-0000
    arm key
    OG001
    arm label
    Diagnostic FES: Patients With FES Negative Sites of Disease
    regimen
    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.
    analyzed count
    3
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00602043-om-0000#groups/OG001
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer-xeloda-717c98d4
    nct id
    NCT00602043
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Diagnostic FES: Average FES SUVmean >1.5, no Negative Sites
    regimen
    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
    analyzed count
    13
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00602043-om-0001#groups/OG000
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer-xeloda-717c98d4
    nct id
    NCT00602043
    outcome key
    om-0001
    arm key
    OG001
    arm label
    Diagnostic FES: Patients With FES Negative Sites of Disease
    regimen
    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.
    analyzed count
    3
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00602043-om-0001#groups/OG001
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer-xeloda-717c98d4
    nct id
    NCT00602043
    outcome key
    om-0002
    arm key
    OG000
    arm label
    Diagnostic (FES): Average FES SUVmean >1.5, no Negative Sites
    regimen
    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.
    analyzed count
    5
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00602043-om-0002#groups/OG000
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer-xeloda-717c98d4
    nct id
    NCT00602043
    outcome key
    om-0002
    arm key
    OG001
    arm label
    Diagnostic FES: Patients With FES Negative Sites of Disease
    regimen
    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.
    analyzed count
    2
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00602043-om-0002#groups/OG001
  7. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer-xeloda-717c98d4
    nct id
    NCT00602043
    outcome key
    om-0003
    arm key
    OG000
    arm label
    Diagnostic (FES)
    regimen
    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. laboratory biomarker analysis: Correlative studies
    analyzed count
    0
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00602043-om-0003#groups/OG000
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer-xeloda-717c98d4
    nct id
    NCT00602043
    harm key
    EG000
    source section id
    NCT00602043-ae
    event group key
    EG000
    event group label
    Diagnostic (FES)
    serious affected
    0
    serious at risk
    20
    other affected
    0
    other at risk
    20
    frequency threshold
    0
    collection period
    Source null
    event definition
    Source null
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
quality of life
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer-xeloda-717c98d4
    nct id
    NCT00602043
    qol key
    qol-0003
    source section id
    NCT00602043-om-0003
    source outcome index
    3
    instrument
    FACT
    instrument basis
    matched 'factors' in the study's own wording
    scale title
    Correlation of FES Uptake With ER Assays
    measure definition
    Graphical and numerical studies of bivariate relationships will be examined, as well as factors (i.e., tumor size, tumor location, patient age) to explain concurrence, lack of concurrence, and sources of measurement error for measurements of ER function.
    time frame
    Up to 6 months
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    Source null
    direction quote
    Source null
    population note
    Data were not collected due to variations in reporting methods for ER assays.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
setting source links

    Preserved source evidence · Not medical advice