MIRNA Profiling of Breast Cancer in Patients Undergoing Neoadjuvant or Adjuvant Treatment for Locally Advanced & Inflammatory Breast Cancer
Aperçu de l'étude
Statut
Les conditions
Description détaillée
Current neoadjuvant or adjuvant treatment strategies do not allow for rationale incorporation of such agents. One needs tools to predict both de novo and acquired resistance to therapeutic agents. This is a difficult task, due to the compound nature of escape routes: tumor exposure is usually to a combination of therapeutic agents and the mechanisms of resistance are broad: intrinsic resistance due to existing mutations, or regulatory - miRNA, other epigenetic - alterations, polymorphisms, tumor cell adaptation via new mutations and activation of alternative pathways, lack of optimal pharmacokinetics/genomics, activation of efflux mechanisms, accelerated repair mechanisms are involved.
Similarly, not all patients who are candidates for primary surgical intervention to be followed by post-operative adjuvant therapy benefit from such systemic treatments. The mechanisms of resistance be it de novo in surviving stem cell/tumorigenic components, or acquired by cells left behind "dormant" after the surgical intervention, are not well delineated.
Breast tumors subjected to neoadjuvant chemotherapy allow for baseline and treatment-effected sampling. Characterization of core biopsy specimens of primary tumors procured prior to exposure to neoadjuvant therapy from different varieties of breast cancer subtypes, and of subsequent mid-treatment and intraoperative (procured during definitive surgery following completion of neoadjuvant therapy) samples should help to assess the predictive value of the pre-treatment and post-treatment miRNA expression profile for complete and near complete response, as a surrogate marker for survival. Similarly, patterns of de novo and acquired resistance may emerge when assessment of pre- and post treatment miRNA expression profiles are analyzed in a supervised manner of classification using pathological response as classifier. Samples obtained from patients with primary surgical removal of their tumors before any systemic treatment exposure on the other hand, will allow for determining markers of prognosis, and predictors for response to therapeutic targeting agents.
Time Perspective: Retrospective/Prospective
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
-
-
California
-
Duarte, California, États-Unis, 91010
- City of Hope
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
Inclusion Criteria:
- Female,
- Breast Cancer
- > 18 years,
- regardless of histology, treatment phase, or stage
Exclusion Criteria:
-
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
|
Performance of miRNA profiling from tumor samples from primary breast tumors
Délai: 3 years after completion of sample collection
|
3 years after completion of sample collection
|
|
Assessment of miRNA profiles from blood/serum samples from patients at baseline, and if feasible, at different time points
Délai: 3 years after completion of sample collection
|
3 years after completion of sample collection
|
|
Analysis of miRNA findings and correlate miRNA patterns of expression in tumor, lymph nodes -if available- and in serum
Délai: 3 years after competion of sample collection
|
3 years after competion of sample collection
|
|
Correlation of classic tumor markers such as estrogen and progesterone receptor (ER,PR), and HER2 expression with tumor stage and grade
Délai: 3 years after completion of sample collection
|
3 years after completion of sample collection
|
|
Determination of specific miRNA functions
Délai: 3 years after completion of sample collection
|
3 years after completion of sample collection
|
|
Determination of ability to knock down functionally relevant overexpressed miRNAs by miR-sponge/antagomirs
Délai: 3 years after completion of sample collection
|
3 years after completion of sample collection
|
|
Design of prospective pilot phase I-II trials to interfere with dysfunctional/dysregulated miRNA expression
Délai: 3 years after completion of sample collection
|
3 years after completion of sample collection
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: George Somlo, MD, City of Hope Medical Center
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 09147
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 .