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FLT PET in Measuring Treatment Response in Patients With Newly Diagnosed Estrogen Receptor-Positive, HER2-Negative Stage I-III Breast Cancer

13 aprile 2018 aggiornato da: Hannah Linden, University of Washington

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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

28

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Stati Uniti
    • Washington
      • Seattle, Washington, Stati Uniti, 98109
        • Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Diagnostico
  • Assegnazione: N / A
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Diagnostic (FLT PET)
Patients undergo FLT PET at baseline and 1-6 weeks after the start of treatment.
Altro: Analisi dei biomarcatori di laboratorio
Studi correlati
Droga: Fluorotimidina F-18
Sottoponiti a FLT PET
Altri nomi:
  • 18F-FLT
  • 3'-deossi-3'-[18F]fluorotimidina
Procedura: Tomografia ad emissione di positroni
Sottoponiti a FLT PET
Altri nomi:
  • Imaging medico, tomografia a emissione di positroni
  • ANIMALE DOMESTICO
  • Scansione animale
  • Scansione di tomografia a emissione di positroni
Droga: Run-in (short pre-surgery course) of endocrine-targeted therapy
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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Percent Change in Net Influx Constant (Ki) by FLT PET
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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.
1 to 6 weeks post-therapy start
Percentage Change in Ki-67 Positive Cells Between Pre-therapy and Post-therapy Tumor Specimens
Lasso di tempo: 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.
Baseline to up to 6 weeks

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Percentage Change in K1 (Blood Flow Parameter) by FLT PET
Lasso di tempo: Baseline to up to 6 weeks
Percent change between pre-treatment (baseline) and post-therapy PET measurements in breast tumors will be computed.
Baseline to up to 6 weeks
Baseline Ki (Flux Constant) Values by FLT PET
Lasso di tempo: Baseline
Ki (flux constant) in breast tumor tissue as determined by the pre-therapy (baseline) FLT PET scan
Baseline
Baseline FLT Transport (K1) Values by FLT PET
Lasso di tempo: Baseline
K1 (blood flow measure) in breast tumor tissue as determined by the pre-therapy (baseline) FLT PET
Baseline
Baseline Standardized Uptake Values (SUV) by FLT PET
Lasso di tempo: Baseline
FLT SUV in breast tumor tissue as determined by the pre-therapy (baseline) FLT PET
Baseline
Post-therapy Ki (Flux Constant) Values by FLT PET
Lasso di tempo: 1 to 6 weeks post-therapy start
Ki (flux constant) in breast tumor tissue as determined by the post-therapy FLT PET
1 to 6 weeks post-therapy start
Post-treatment FLT Transport (K1) Values by FLT PET
Lasso di tempo: 1 to 6 weeks post-therapy start
K1 (blood flow measure) in breast tumor tissue as determined by the post-therapy FLT PET
1 to 6 weeks post-therapy start
Post-treatment Standardized Uptake Values (SUV) by FLT PET
Lasso di tempo: 1 to 6 weeks post-therapy start
FLT SUV in breast tumor tissue as determined by the post-treatment FLT PET
1 to 6 weeks post-therapy start

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Post-treatment Gene Expression Levels
Lasso di tempo: 1 to 6 weeks post-therapy start
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.
1 to 6 weeks post-therapy start
Pre-treatment Gene Expression Levels
Lasso di tempo: Baseline
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.
Baseline

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

University of Washington

Collaboratori

National Cancer Institute (NCI)

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 settembre 2011

Completamento primario (Effettivo)

20 luglio 2015

Completamento dello studio (Effettivo)

20 luglio 2015

Date di iscrizione allo studio

Primo inviato

20 agosto 2013

Primo inviato che soddisfa i criteri di controllo qualità

20 agosto 2013

Primo Inserito (Stima)

23 agosto 2013

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

15 maggio 2018

Ultimo aggiornamento inviato che soddisfa i criteri QC

13 aprile 2018

Ultimo verificato

1 aprile 2018

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 7536 (Altro identificatore: Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium)
  • P30CA015704 (Sovvenzione/contratto NIH degli Stati Uniti)
  • NCI-2013-01380 (Identificatore di registro: CTRP (Clinical Trial Reporting Program))
  • RC1CA146456 (Sovvenzione/contratto NIH degli Stati Uniti)

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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