Cette page a été traduite automatiquement et l'exactitude de la traduction n'est pas garantie. Veuillez vous référer au version anglaise pour un texte source.

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

13 avril 2018 mis à jour par: 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.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Réel)

28

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • États-Unis
    • Washington
      • Seattle, Washington, États-Unis, 98109
        • Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Diagnostique
  • Répartition: N / A
  • Modèle interventionnel: Affectation à un seul groupe
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Diagnostic (FLT PET)
Patients undergo FLT PET at baseline and 1-6 weeks after the start of treatment.
Autre: Analyse de biomarqueurs en laboratoire
Études corrélatives
Médicament: Fluorothymidine F-18
Subir FLT PET
Autres noms:
  • 18F-FLT
  • 3'-désoxy-3'-[18F]fluorothymidine
Procédure: Tomographie par émission de positrons
Subir FLT PET
Autres noms:
  • Imagerie médicale, Tomographie par émission de positrons
  • ANIMAUX
  • TEP-scan
  • Scan de tomographie par émission de positrons
Médicament: 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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Percent Change in Net Influx Constant (Ki) by FLT PET
Délai: 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
Délai: 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
Délai: 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
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Percentage Change in K1 (Blood Flow Parameter) by FLT PET
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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

Autres mesures de résultats

Mesure des résultats
Description de la mesure
Délai
Post-treatment Gene Expression Levels
Délai: 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
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

University of Washington

Collaborateurs

National Cancer Institute (NCI)

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 septembre 2011

Achèvement primaire (Réel)

20 juillet 2015

Achèvement de l'étude (Réel)

20 juillet 2015

Dates d'inscription aux études

Première soumission

20 août 2013

Première soumission répondant aux critères de contrôle qualité

20 août 2013

Première publication (Estimation)

23 août 2013

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

15 mai 2018

Dernière mise à jour soumise répondant aux critères de contrôle qualité

13 avril 2018

Dernière vérification

1 avril 2018

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 7536 (Autre identifiant: Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium)
  • P30CA015704 (Subvention/contrat des NIH des États-Unis)
  • NCI-2013-01380 (Identificateur de registre: CTRP (Clinical Trial Reporting Program))
  • RC1CA146456 (Subvention/contrat des NIH des États-Unis)

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

Essais cliniques sur Analyse de biomarqueurs en laboratoire

Rechercher des essais similaires

Sponsors et collaborateurs

Les conditions médicales

Interventions en matière de drogue

CROs by country

CROs in Mauritania

Conditions

Maladies rares

Interventions en matière de drogue

Compléments alimentaires

Commanditaire / collaborateurs

Emplacements

3
S'abonner