- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01928186
FLT PET in Measuring Treatment Response in Patients With Newly Diagnosed Estrogen Receptor-Positive, HER2-Negative Stage I-III Breast Cancer
Imaging Early Response of ER+, HER2- Breast Cancer to Aromatase Inhibitor (AI) +/- Ovarian Suppression (OS) Therapy With [18F]Fluorothymidine (FLT) PET
Studieoversikt
Status
Forhold
Detaljert beskrivelse
PRIMARY OBJECTIVES:
I. 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:
I. 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.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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Washington
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Seattle, Washington, Forente stater, 98109
- Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- 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
- 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
Exclusion Criteria:
- 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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Diagnostisk
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: Diagnostic (FLT PET)
Patients undergo FLT PET at baseline and 1-6 weeks after the start of treatment.
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Korrelative studier
Gjennomgå FLT PET
Andre navn:
Gjennomgå FLT PET
Andre navn:
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.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Percent Change in Net Influx Constant (Ki) by FLT PET
Tidsramme: 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. |
Baseline to up to 6 weeks
|
Percent Change in SUV by FLT PET
Tidsramme: 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.
|
Baseline to up to 6 weeks
|
Percentage of Ki-67 Positive Tumor Cells in Surgical (Post-therapy) Sample
Tidsramme: 1 to 6 weeks post-therapy start
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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.
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1 to 6 weeks post-therapy start
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Percentage Change in Ki-67 Positive Cells Between Pre-therapy and Post-therapy Tumor Specimens
Tidsramme: Baseline to up to 6 weeks
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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. |
Baseline to up to 6 weeks
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Percentage Change in K1 (Blood Flow Parameter) by FLT PET
Tidsramme: Baseline to up to 6 weeks
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Percent change between pre-treatment (baseline) and post-therapy PET measurements in breast tumors will be computed.
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Baseline to up to 6 weeks
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Baseline Ki (Flux Constant) Values by FLT PET
Tidsramme: Baseline
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Ki (flux constant) in breast tumor tissue as determined by the pre-therapy (baseline) FLT PET scan
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Baseline
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Baseline FLT Transport (K1) Values by FLT PET
Tidsramme: Baseline
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K1 (blood flow measure) in breast tumor tissue as determined by the pre-therapy (baseline) FLT PET
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Baseline
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Baseline Standardized Uptake Values (SUV) by FLT PET
Tidsramme: Baseline
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FLT SUV in breast tumor tissue as determined by the pre-therapy (baseline) FLT PET
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Baseline
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Post-therapy Ki (Flux Constant) Values by FLT PET
Tidsramme: 1 to 6 weeks post-therapy start
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Ki (flux constant) in breast tumor tissue as determined by the post-therapy FLT PET
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1 to 6 weeks post-therapy start
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Post-treatment FLT Transport (K1) Values by FLT PET
Tidsramme: 1 to 6 weeks post-therapy start
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K1 (blood flow measure) in breast tumor tissue as determined by the post-therapy FLT PET
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1 to 6 weeks post-therapy start
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Post-treatment Standardized Uptake Values (SUV) by FLT PET
Tidsramme: 1 to 6 weeks post-therapy start
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FLT SUV in breast tumor tissue as determined by the post-treatment FLT PET
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1 to 6 weeks post-therapy start
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Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Post-treatment Gene Expression Levels
Tidsramme: 1 to 6 weeks post-therapy start
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Analyzed 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.
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1 to 6 weeks post-therapy start
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Pre-treatment Gene Expression Levels
Tidsramme: Baseline
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Analyzed 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.
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Baseline
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Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 7536 (Annen identifikator: Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium)
- P30CA015704 (U.S. NIH-stipend/kontrakt)
- NCI-2013-01380 (Registeridentifikator: CTRP (Clinical Trial Reporting Program))
- RC1CA146456 (U.S. NIH-stipend/kontrakt)
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