Trial Outcomes & Findings for FLT PET in Measuring Treatment Response in Patients With Newly Diagnosed Estrogen Receptor-Positive, HER2-Negative Stage I-III Breast Cancer (NCT NCT01928186)
NCT ID: NCT01928186
Last Updated: 2018-05-15
Results Overview
Percent change between pre-treatment (baseline) and post-therapy PET measurements in breast tumors will be computed. Association between Ki-67 and Ki by FLT (KFLT) decline will be analyzed using the mid-P adjustment to Fisher's exact test to evaluate the potential clinical utility of change in FLT as a biomarker for early response, using Ki-67 as the standard for early response.
COMPLETED
NA
28 participants
Baseline to up to 6 weeks
2018-05-15
Participant Flow
Participant milestones
| Measure |
Diagnostic (FLT PET)
Patients undergo FLT PET at baseline and 1-6 weeks after the start of treatment.
Fluorothymidine F-18: Undergo FLT PET
Positron Emission Tomography: Undergo FLT PET
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|
|
Overall Study
STARTED
|
28
|
|
Overall Study
COMPLETED
|
28
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
FLT PET in Measuring Treatment Response in Patients With Newly Diagnosed Estrogen Receptor-Positive, HER2-Negative Stage I-III Breast Cancer
Baseline characteristics by cohort
| Measure |
Diagnostic (FLT PET)
n=28 Participants
Patients with early stage, ER positive primary breast cancer undergo FLT PET scan at baseline and 1-6 weeks after the start of standard endocrine treatment. The surgery follows 1-7 days after the second FLT PET scan.
Tracer used in the FLT PET (positron emission tomography) scanning procedure: \[F18\] fluorothymidine.
Positron Emission Tomography: Undergo FLT PET
Laboratory Biomarker Analysis: Correlative studies - Ki67 staining of the tumor tissue in the biopsy and surgical specimen.
|
|---|---|
|
Age, Continuous
|
60.4 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
27 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
25 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Clinical stage
Stage I
|
10 Participants
n=5 Participants
|
|
Clinical stage
Stage IIA
|
14 Participants
n=5 Participants
|
|
Clinical stage
Stage IIB
|
4 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to up to 6 weeksPercent change between pre-treatment (baseline) and post-therapy PET measurements in breast tumors will be computed. Association between Ki-67 and Ki by FLT (KFLT) decline will be analyzed using the mid-P adjustment to Fisher's exact test to evaluate the potential clinical utility of change in FLT as a biomarker for early response, using Ki-67 as the standard for early response.
Outcome measures
| Measure |
Diagnostic (FLT PET)
n=28 Participants
Patients with early stage, ER positive primary breast cancer undergo FLT PET scan at baseline and 1-6 weeks after the start of standard endocrine treatment. The surgery follows 1-7 days after the second FLT PET scan.
Tracer used in the FLT PET (positron emission tomography) scanning procedure: \[F18\] fluorothymidine.
Positron Emission Tomography: Undergo FLT PET
Laboratory Biomarker Analysis: Correlative studies - Ki67 staining of the tumor tissue in the biopsy and surgical specimen.
|
|---|---|
|
Percent Change in Net Influx Constant (Ki) by FLT PET
|
-32.0 % change
Interval -82.4 to 3953.7
|
PRIMARY outcome
Timeframe: Baseline to up to 6 weeksPercent change between pre-treatment (baseline) and post-therapy measurements of FLT standardized uptake value (SUV) in breast tumors will be computed.
Outcome measures
| Measure |
Diagnostic (FLT PET)
n=28 Participants
Patients with early stage, ER positive primary breast cancer undergo FLT PET scan at baseline and 1-6 weeks after the start of standard endocrine treatment. The surgery follows 1-7 days after the second FLT PET scan.
Tracer used in the FLT PET (positron emission tomography) scanning procedure: \[F18\] fluorothymidine.
Positron Emission Tomography: Undergo FLT PET
Laboratory Biomarker Analysis: Correlative studies - Ki67 staining of the tumor tissue in the biopsy and surgical specimen.
|
|---|---|
|
Percent Change in SUV by FLT PET
|
-26.6 % change
Interval -77.3 to 7.4
|
PRIMARY outcome
Timeframe: 1 to 6 weeks post-therapy startSurgically removed breast tumor tissue is stained using immuno-histochemistry techniques to visualize dividing cells expressing the Ki-67 protein, which is a cellular marker for proliferation.
Outcome measures
| Measure |
Diagnostic (FLT PET)
n=28 Participants
Patients with early stage, ER positive primary breast cancer undergo FLT PET scan at baseline and 1-6 weeks after the start of standard endocrine treatment. The surgery follows 1-7 days after the second FLT PET scan.
Tracer used in the FLT PET (positron emission tomography) scanning procedure: \[F18\] fluorothymidine.
Positron Emission Tomography: Undergo FLT PET
Laboratory Biomarker Analysis: Correlative studies - Ki67 staining of the tumor tissue in the biopsy and surgical specimen.
|
|---|---|
|
Percentage of Ki-67 Positive Tumor Cells in Surgical (Post-therapy) Sample
|
3 % stained cells
Interval 0.0 to 40.0
|
PRIMARY outcome
Timeframe: Baseline to up to 6 weeksTumor tissue samples from pre-treatment (baseline) biopsy and post-treatment surgery are stained using immuno-histochemistry techniques to visualize dividing cells expressing the Ki-67 protein, which is a cellular marker for proliferation. The % values of positive cells from the baseline and post-treatment samples are then compared for each individual patient. Association between Ki-67 and KFLT decline will be analyzed to evaluate the potential clinical utility of change in FLT as a biomarker for early response, using Ki-67 as the standard for early response.
Outcome measures
| Measure |
Diagnostic (FLT PET)
n=28 Participants
Patients with early stage, ER positive primary breast cancer undergo FLT PET scan at baseline and 1-6 weeks after the start of standard endocrine treatment. The surgery follows 1-7 days after the second FLT PET scan.
Tracer used in the FLT PET (positron emission tomography) scanning procedure: \[F18\] fluorothymidine.
Positron Emission Tomography: Undergo FLT PET
Laboratory Biomarker Analysis: Correlative studies - Ki67 staining of the tumor tissue in the biopsy and surgical specimen.
|
|---|---|
|
Percentage Change in Ki-67 Positive Cells Between Pre-therapy and Post-therapy Tumor Specimens
|
-80.0 % change
Interval -100.0 to 400.0
|
SECONDARY outcome
Timeframe: Baseline to up to 6 weeksPercent change between pre-treatment (baseline) and post-therapy PET measurements in breast tumors will be computed.
Outcome measures
| Measure |
Diagnostic (FLT PET)
n=28 Participants
Patients with early stage, ER positive primary breast cancer undergo FLT PET scan at baseline and 1-6 weeks after the start of standard endocrine treatment. The surgery follows 1-7 days after the second FLT PET scan.
Tracer used in the FLT PET (positron emission tomography) scanning procedure: \[F18\] fluorothymidine.
Positron Emission Tomography: Undergo FLT PET
Laboratory Biomarker Analysis: Correlative studies - Ki67 staining of the tumor tissue in the biopsy and surgical specimen.
|
|---|---|
|
Percentage Change in K1 (Blood Flow Parameter) by FLT PET
|
-6.2 % change
Interval -94.6 to 262.1
|
SECONDARY outcome
Timeframe: BaselineKi (flux constant) in breast tumor tissue as determined by the pre-therapy (baseline) FLT PET scan
Outcome measures
| Measure |
Diagnostic (FLT PET)
n=28 Participants
Patients with early stage, ER positive primary breast cancer undergo FLT PET scan at baseline and 1-6 weeks after the start of standard endocrine treatment. The surgery follows 1-7 days after the second FLT PET scan.
Tracer used in the FLT PET (positron emission tomography) scanning procedure: \[F18\] fluorothymidine.
Positron Emission Tomography: Undergo FLT PET
Laboratory Biomarker Analysis: Correlative studies - Ki67 staining of the tumor tissue in the biopsy and surgical specimen.
|
|---|---|
|
Baseline Ki (Flux Constant) Values by FLT PET
|
0.015 mL/min/mL
Interval 0.0025 to 0.0353
|
SECONDARY outcome
Timeframe: BaselineK1 (blood flow measure) in breast tumor tissue as determined by the pre-therapy (baseline) FLT PET
Outcome measures
| Measure |
Diagnostic (FLT PET)
n=28 Participants
Patients with early stage, ER positive primary breast cancer undergo FLT PET scan at baseline and 1-6 weeks after the start of standard endocrine treatment. The surgery follows 1-7 days after the second FLT PET scan.
Tracer used in the FLT PET (positron emission tomography) scanning procedure: \[F18\] fluorothymidine.
Positron Emission Tomography: Undergo FLT PET
Laboratory Biomarker Analysis: Correlative studies - Ki67 staining of the tumor tissue in the biopsy and surgical specimen.
|
|---|---|
|
Baseline FLT Transport (K1) Values by FLT PET
|
0.0501 mL/min/mL
Interval 0.0119 to 0.3699
|
SECONDARY outcome
Timeframe: BaselineFLT SUV in breast tumor tissue as determined by the pre-therapy (baseline) FLT PET
Outcome measures
| Measure |
Diagnostic (FLT PET)
n=28 Participants
Patients with early stage, ER positive primary breast cancer undergo FLT PET scan at baseline and 1-6 weeks after the start of standard endocrine treatment. The surgery follows 1-7 days after the second FLT PET scan.
Tracer used in the FLT PET (positron emission tomography) scanning procedure: \[F18\] fluorothymidine.
Positron Emission Tomography: Undergo FLT PET
Laboratory Biomarker Analysis: Correlative studies - Ki67 staining of the tumor tissue in the biopsy and surgical specimen.
|
|---|---|
|
Baseline Standardized Uptake Values (SUV) by FLT PET
|
2.5 g/mL
Interval 1.06 to 7.77
|
SECONDARY outcome
Timeframe: 1 to 6 weeks post-therapy startKi (flux constant) in breast tumor tissue as determined by the post-therapy FLT PET
Outcome measures
| Measure |
Diagnostic (FLT PET)
n=28 Participants
Patients with early stage, ER positive primary breast cancer undergo FLT PET scan at baseline and 1-6 weeks after the start of standard endocrine treatment. The surgery follows 1-7 days after the second FLT PET scan.
Tracer used in the FLT PET (positron emission tomography) scanning procedure: \[F18\] fluorothymidine.
Positron Emission Tomography: Undergo FLT PET
Laboratory Biomarker Analysis: Correlative studies - Ki67 staining of the tumor tissue in the biopsy and surgical specimen.
|
|---|---|
|
Post-therapy Ki (Flux Constant) Values by FLT PET
|
0.0142 mL/min/mL
Interval 0.0015 to 0.0352
|
SECONDARY outcome
Timeframe: 1 to 6 weeks post-therapy startK1 (blood flow measure) in breast tumor tissue as determined by the post-therapy FLT PET
Outcome measures
| Measure |
Diagnostic (FLT PET)
n=28 Participants
Patients with early stage, ER positive primary breast cancer undergo FLT PET scan at baseline and 1-6 weeks after the start of standard endocrine treatment. The surgery follows 1-7 days after the second FLT PET scan.
Tracer used in the FLT PET (positron emission tomography) scanning procedure: \[F18\] fluorothymidine.
Positron Emission Tomography: Undergo FLT PET
Laboratory Biomarker Analysis: Correlative studies - Ki67 staining of the tumor tissue in the biopsy and surgical specimen.
|
|---|---|
|
Post-treatment FLT Transport (K1) Values by FLT PET
|
0.0675 mL/min/mL
Interval 0.0018 to 0.4335
|
SECONDARY outcome
Timeframe: 1 to 6 weeks post-therapy startFLT SUV in breast tumor tissue as determined by the post-treatment FLT PET
Outcome measures
| Measure |
Diagnostic (FLT PET)
n=28 Participants
Patients with early stage, ER positive primary breast cancer undergo FLT PET scan at baseline and 1-6 weeks after the start of standard endocrine treatment. The surgery follows 1-7 days after the second FLT PET scan.
Tracer used in the FLT PET (positron emission tomography) scanning procedure: \[F18\] fluorothymidine.
Positron Emission Tomography: Undergo FLT PET
Laboratory Biomarker Analysis: Correlative studies - Ki67 staining of the tumor tissue in the biopsy and surgical specimen.
|
|---|---|
|
Post-treatment Standardized Uptake Values (SUV) by FLT PET
|
1.76 g/mL
Interval 0.76 to 3.78
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 1 to 6 weeks post-therapy startAnalyzed using BeadStudio software. Four clustering metrics for calculating dissimilarities (correlation, absolute correlation, Euclidean, and Manhattan) are available in BeadStudio and will be applied using standard analysis methods and diagnostics in BioConductor. To focus the analysis, proposed gene sets will be examined based on biological pathways and molecular signatures.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: BaselineAnalyzed using BeadStudio software. Four clustering metrics for calculating dissimilarities (correlation, absolute correlation, Euclidean, and Manhattan) are available in BeadStudio and will be applied using standard analysis methods and diagnostics in BioConductor. To focus the analysis, proposed gene sets will be examined based on biological pathways and molecular signatures.
Outcome measures
Outcome data not reported
Adverse Events
Diagnostic (FLT PET)
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Diagnostic (FLT PET)
n=28 participants at risk
Patients with early stage, ER positive primary breast cancer undergo FLT PET scan at baseline and 1-6 weeks after the start of standard endocrine treatment. The surgery follows 1-7 days after the second FLT PET scan.
Tracer used in the FLT PET (positron emission tomography) scanning procedure: \[F18\] fluorothymidine.
Positron Emission Tomography: Undergo FLT PET
Laboratory Biomarker Analysis: Correlative studies - Ki67 staining of the tumor tissue in the biopsy and surgical specimen.
|
|---|---|
|
Injury, poisoning and procedural complications
Infiltration at injection site
|
3.6%
1/28 • Number of events 1
|
Additional Information
Dr. Hannah Linden
University of Washington / Seattle Cancer Care Alliance
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place