Estrogen Receptor PositiveNCT01928186
FLT PET in Measuring Treatment Response in Patients With Newly Diagnosed Estrogen Receptor-Positive, HER2-Negative Stage I-III Breast Cancer
A study testing Fluorothymidine F-18, Positron Emission Tomography and Laboratory Biomarker Analysis in people with Estrogen Receptor Positive and HER2/Neu Negative, run by University of Washington at 1 site in United States.
Trial summary
This clinical trial studies fluorine F 18 fluorothymidine (FLT) positron emission tomography (PET) in measuring treatment response in patients with newly diagnosed estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative stage I-III breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Estrogen Receptor Positive, HER2/Neu Negative, Male Breast Carcinoma
- What is being tested?
- Fluorothymidine F-18, Positron Emission Tomography and Laboratory Biomarker Analysis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2011to 20 Jul 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A new diagnosis of invasive breast cancer > 1.0 cm in size, ER+ clinical stage I-III
- Patient must have surgical resection followed by systemic adjuvant therapy with an aromatase inhibitor (AIs) as part of planned treatment; any approved AI at standard clinical dosing may be used; in pre-menopausal patients, ovarian suppression with a gonadotropin-releasing hormone (GnRH) agonist will be started prior to initiation of the AI on a separate clinical trial in parallel with the imaging study
- Have tissue block available from core biopsy for correlative biomarkers and genomic assay
- Have menopausal status determined prior to study enrollment; for study purposes, postmenopausal is defined as
- A prior documented bilateral oophorectomy, or
- A history of at least 12 months without spontaneous menstrual bleeding, or
Show all 13Show fewer
- Age 60 or older with a prior hysterectomy without oophorectomy, or
- Age less than 60 with a prior hysterectomy without oophorectomy (or in whom the status of the ovaries is unknown) with a documented follicle-stimulating hormone (FSH) level demonstrating confirmatory elevation in the postmenopausal range for the lab
- Negative pregnancy test within 7 days of baseline positron emission tomography (PET) scan for pre-menopausal patients
- Tumor HER2/neu expression must be determined (as part of standard clinical care) prior to study enrollment; HER2 may be tested by any Food and Drug Administration (FDA) approved HER2 testing method; if determination is intermediate by immunohistochemistry (IHC), fluorescent in situ hybridization (FISH) or another alternate HER2 test must be performed
- Be a candidate for [18F]FLT PET imaging
- Be informed of the investigational nature of this study and provide written informed consent in accordance with institutional and federal guidelines prior to study-specific screening procedures
- Be willing and able to comply with scheduled visits and other trial procedures
Who cannot join
- Current use of aromatase inhibitor as prevention or treatment for breast cancer
- Life expectancy of less than two months
- HER2/neu positive by IHC and/or another FDA approved HER2 testing method
- Inability to tolerate scanning (e.g. - claustrophobia, severe pain)
- Weight exceeding capacity of imaging table
Trial locations and contacts
1 site in 1 country.
United States1 site
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Seattle, Washington, 98109
About this study
Official title: Imaging Early Response of ER+, HER2- Breast Cancer to Aromatase Inhibitor (AI) +/- Ovarian Suppression (OS) Therapy With [18F]Fluorothymidine (FLT) PET
This clinical trial studies fluorine F 18 fluorothymidine (FLT) positron emission tomography (PET) in measuring treatment response in patients with newly diagnosed estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative stage I-III breast cancer. Comparing results of diagnostic procedures done before and during hormone therapy may help doctors predict a patient's response to treatment and help plan the best treatment.
Read the detailed description
PRIMARY OBJECTIVES:
- Measure the effect of a short course of endocrine therapy on primary breast cancer metabolism and proliferation by measuring changes in serial FLT PET measures pre and post a short course of endocrine therapy.
SECONDARY OBJECTIVES:
- Compare changes in imaging measures to tissue measures of response, in particular antigen identified by proliferation-related Ki-67 antigen (Ki-67), in the pre-therapy biopsy versus the post-therapy surgical specimen.
II. Correlate imaging measures to measures of gene expression from pre and post therapy assays to determine if there are molecular changes associated with early response to therapy.
OUTLINE:
Patients undergo FLT PET at baseline and 1-6 weeks after the start of treatment.
- Conditions
- Estrogen Receptor Positive, HER2/Neu Negative, Male Breast Carcinoma, Stage IA Breast Cancer, Stage IB Breast Cancer, Stage IIA Breast Cancer
- Being tested
- Fluorothymidine F-18, Positron Emission Tomography, Laboratory Biomarker Analysis, Run-in (short pre-surgery course) of endocrine-targeted therapy
- Medical subject headings
- Breast Neoplasms, Male, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluorothymidine F-18Drug
Also called 18F-FLT, 3'-deoxy-3'-[18F]fluorothymidine
Undergo FLT PET
Positron Emission TomographyProcedure or surgery
Also called Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron Emission Tomography Scan
Undergo FLT PET
Laboratory Biomarker AnalysisOther
Correlative studies
Run-in (short pre-surgery course) of endocrine-targeted therapyDrug
Patients undergo run-in (short pre-surgery course) of endocrine-targeted therapy with aromatase inhibitor between the two (baseline and repeat) FLT PET scans. This is not an experimental therapy. This is a standard of care therapy that patients will continue after surgery, when the study is completed.
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic (FLT PET) | Experimental | Patients undergo FLT PET at baseline and 1-6 weeks after the start of treatment. Receives: Drug: Fluorothymidine F-18; Procedure: Positron Emission Tomography; Other: Laboratory Biomarker Analysis; Drug: Run-in (short pre-surgery course) of endocrine-targeted therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change in Net Influx Constant (Ki) by FLT PET
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.
Measured: Baseline to up to 6 weeks
Percent Change in SUV by FLT PET
Percent change between pre-treatment (baseline) and post-therapy measurements of FLT standardized uptake value (SUV) in breast tumors will be computed.
Measured: Baseline to up to 6 weeks
Percentage of Ki-67 Positive Tumor Cells in Surgical (Post-therapy) Sample
Surgically 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.
Measured: 1 to 6 weeks post-therapy start
Percentage Change in Ki-67 Positive Cells Between Pre-therapy and Post-therapy Tumor Specimens
Tumor 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.
Measured: Baseline to up to 6 weeks
Secondary outcomes (7)
Percentage Change in K1 (Blood Flow Parameter) by FLT PET
Percent change between pre-treatment (baseline) and post-therapy PET measurements in breast tumors will be computed.
Measured: Baseline to up to 6 weeks
Baseline Ki (Flux Constant) Values by FLT PET
Ki (flux constant) in breast tumor tissue as determined by the pre-therapy (baseline) FLT PET scan
Measured: Baseline
Baseline FLT Transport (K1) Values by FLT PET
K1 (blood flow measure) in breast tumor tissue as determined by the pre-therapy (baseline) FLT PET
Measured: Baseline
Baseline Standardized Uptake Values (SUV) by FLT PET
FLT SUV in breast tumor tissue as determined by the pre-therapy (baseline) FLT PET
Measured: Baseline
Post-therapy Ki (Flux Constant) Values by FLT PET
Ki (flux constant) in breast tumor tissue as determined by the post-therapy FLT PET
Measured: 1 to 6 weeks post-therapy start
Post-treatment FLT Transport (K1) Values by FLT PET
K1 (blood flow measure) in breast tumor tissue as determined by the post-therapy FLT PET
Measured: 1 to 6 weeks post-therapy start
Post-treatment Standardized Uptake Values (SUV) by FLT PET
FLT SUV in breast tumor tissue as determined by the post-treatment FLT PET
Measured: 1 to 6 weeks post-therapy start
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2013 (estimated)
- Study startSep 2011
- Primary completion20 Jul 2015
- Study completion20 Jul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Estrogen Receptor PositiveStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Hannah Linden, University of Washington
- Investigators
- Hannah Linden, Principal investigator, Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01928186
- Sponsor's protocol ID
- 7536
- Other IDs
- NCI-2013-01380, 7536, P30CA015704, RC1CA146456
- Status last verified
- Apr 2018
- First submitted
- 20 Aug 2013
- Last updated
- 15 May 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Imaging Early Response of ER+, HER2- Breast Cancer to Aromatase Inhibitor (AI) +/- Ovarian Suppression (OS) Therapy With [18F]Fluorothymidine (FLT) PET
- ClinicalTrials.gov ID
- NCT01928186
- Acronym / sponsor ID
- 7536
- Conditions
- Estrogen Receptor Positive, HER2/Neu Negative, Male Breast Carcinoma, Stage IA Breast Cancer, Stage IB Breast Cancer, Stage IIA Breast Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Sep 2011
- Primary completion
- 20 Jul 2015 (actual)
- Study completion
- 20 Jul 2015 (actual)
- First posted
- 23 Aug 2013 (estimated)
- Results
- Posted 25 Sep 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This clinical trial studies fluorine F 18 fluorothymidine (FLT) positron emission tomography (PET) in measuring treatment response in patients with newly diagnosed estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative stage I-III breast cancer. Comparing results of diagnostic procedures done before and during hormone therapy may help doctors predict a patient's response to treatment and help plan the best treatment.
Detailed description
PRIMARY OBJECTIVES:
- Measure the effect of a short course of endocrine therapy on primary breast cancer metabolism and proliferation by measuring changes in serial FLT PET measures pre and post a short course of endocrine therapy.
SECONDARY OBJECTIVES:
- Compare changes in imaging measures to tissue measures of response, in particular antigen identified by proliferation-related Ki-67 antigen (Ki-67), in the pre-therapy biopsy versus the post-therapy surgical specimen.
II. Correlate imaging measures to measures of gene expression from pre and post therapy assays to determine if there are molecular changes associated with early response to therapy.
OUTLINE:
Patients undergo FLT PET at baseline and 1-6 weeks after the start of treatment.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnostic (FLT PET) | Experimental | Drug: Fluorothymidine F-18, Procedure: Positron Emission Tomography, Other: Laboratory Biomarker Analysis, Drug: Run-in (short pre-surgery course) of endocrine-targeted therapyPatients undergo FLT PET at baseline and 1-6 weeks after the start of treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- A new diagnosis of invasive breast cancer > 1.0 cm in size, ER+ clinical stage I-III
- Patient must have surgical resection followed by systemic adjuvant therapy with an aromatase inhibitor (AIs) as part of planned treatment; any approved AI at standard clinical dosing may be used; in pre-menopausal patients, ovarian suppression with a gonadotropin-releasing hormone (GnRH) agonist will be started prior to initiation of the AI on a separate clinical trial in parallel with the imaging study
- Have tissue block available from core biopsy for correlative biomarkers and genomic assay
- Have menopausal status determined prior to study enrollment; for study purposes, postmenopausal is defined as
- Negative pregnancy test within 7 days of baseline positron emission tomography (PET) scan for pre-menopausal patients
Key exclusion criteria (5 listed)
- Current use of aromatase inhibitor as prevention or treatment for breast cancer
- Life expectancy of less than two months
- HER2/neu positive by IHC and/or another FDA approved HER2 testing method
- Inability to tolerate scanning (e.g. - claustrophobia, severe pain)
- Weight exceeding capacity of imaging table
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fluorothymidine F-18Also: 18F-FLT, 3'-deoxy-3'-[18F]fluorothymidineUndergo FLT PET | Drug | Diagnostic (FLT PET) |
| Positron Emission TomographyAlso: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron Emission Tomography ScanUndergo FLT PET | Procedure or surgery | Diagnostic (FLT PET) |
| Laboratory Biomarker AnalysisCorrelative studies | Other | Diagnostic (FLT PET) |
| Run-in (short pre-surgery course) of endocrine-targeted therapyPatients undergo run-in (short pre-surgery course) of endocrine-targeted therapy with aromatase inhibitor between the two (baseline and repeat) FLT PET scans. This is not an experimental therapy. This is a standard of care therapy that patients will continue after surgery, when the study is completed. | Drug | Diagnostic (FLT PET) |
Primary outcome
Percent Change in Net Influx Constant (Ki) by FLT PET
Time frame: Baseline to up to 6 weeks
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.
Percent Change in SUV by FLT PET
Time frame: Baseline to up to 6 weeks
Percent change between pre-treatment (baseline) and post-therapy measurements of FLT standardized uptake value (SUV) in breast tumors will be computed.
Percentage of Ki-67 Positive Tumor Cells in Surgical (Post-therapy) Sample
Time frame: 1 to 6 weeks post-therapy start
Surgically 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.
Percentage Change in Ki-67 Positive Cells Between Pre-therapy and Post-therapy Tumor Specimens
Time frame: Baseline to up to 6 weeks
Tumor 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.
7 secondary outcomes
Percentage Change in K1 (Blood Flow Parameter) by FLT PET
Time frame: Baseline to up to 6 weeks
Baseline Ki (Flux Constant) Values by FLT PET
Time frame: Baseline
Baseline FLT Transport (K1) Values by FLT PET
Time frame: Baseline
Baseline Standardized Uptake Values (SUV) by FLT PET
Time frame: Baseline
Post-therapy Ki (Flux Constant) Values by FLT PET
Time frame: 1 to 6 weeks post-therapy start
Post-treatment FLT Transport (K1) Values by FLT PET
Time frame: 1 to 6 weeks post-therapy start
Post-treatment Standardized Uptake Values (SUV) by FLT PET
Time frame: 1 to 6 weeks post-therapy start
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hannah Linden principal investigator
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fluorothymidine F-18, Positron Emission Tomography and Laboratory Biomarker Analysis in people with Estrogen Receptor Positive and HER2/Neu Negative, run by University of Washington at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Sep 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Change in Net Influx Constant (Ki) by FLT PET (time frame: Baseline to up to 6 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2018.