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Pharmacogenomic Study of Neoadjuvant Eribulin for HER2 Non-overexpressing Breast Cancer (NeoEribulin)

31 ottobre 2017 aggiornato da: SOLTI Breast Cancer Research Group

A Phase II, Open-label, Single-arm, Exploratory Pharmacogenomic Study of Single Agent Eribulin (HALAVEN®) as Neoadjuvant Treatment for Operable Stage I-II HER2 Non-overexpressing Breast Cancer.

This is a prospective, non-randomized, open-label, multicenter, single-arm exploratory pharmacogenomic study of single agent eribulin as neoadjuvant therapy in patients with operable Stage III HER2 non-overexpressing breast cancer.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

163

Fase

  • Fase 2

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

  • Francia
      • Villejuif, Francia, 94800
        • Institut Gustave Roussy
  • Germania
      • Deggendorf, Germania, 94469
        • Klinikum des Landkreises Deggendorf Frauenklinik Mammazentrum
      • Köln, Germania, 51067
        • Brustzentrum im Krankenhaus Köln-Holweide Priv. Doz.
      • Munic, Germania, 81377
        • Brustzentrum der Universität München
      • Rostock, Germania, 18059
        • Klinikum Südstadt Rostock, Universitätsfrauenklinik und Poliklinik
  • Portogallo
      • Coimbra, Portogallo, 3001-651
        • Instituto Portugues de Oncologia de Coimbra Francisco Gentil, EPE
      • Lisboa, Portogallo, 1500-650
        • Hospital da Luz
      • Porto, Portogallo, 4200-072
        • Instituto Portugues de Oncologia de Porto Francisco Gentil, EPE
  • Spagna
      • Barcelona, Spagna, 08025
        • Hospital de la Santa Creu i Sant Pau
      • Barcelona, Spagna
        • Hospital Universitario Vall d´Hebron
      • Barcelona, Spagna, 08035
        • Hospital Universitario Vall d´Hebron
      • Castelló de la Plana, Spagna, 12002
        • Complejo Hospitalario de Castellón
      • Cáceres, Spagna, 10003
        • Complejo Hospitalario San Pedro de Alcántara
      • Córdoba, Spagna, 14004
        • Hospital Universitario Reina Sofia
      • Denia, Spagna, 03700
        • Hospital Marina Salud de Denia
      • Jaén, Spagna, 23007
        • Complejo Hospitalario de Jaén
      • Lleida, Spagna, 25198
        • Hospital Universitari Arnau de Vilanova de Lleida
      • Madrid, Spagna, 28034
        • Hospital Universitario Ramon y Cajal
      • Madrid, Spagna, 28041
        • Hospital Universitario 12 de Octubre
      • Madrid, Spagna, 28040
        • Hospital Universitario Clínico San Carlos
      • Madrid, Spagna, 28222
        • Hospital Universitario Puerta de Hierro de Majadahonda
      • Murcia, Spagna, 30120
        • Hospital Universitario Virgen de La Arrixaca
      • Reus, Spagna, 43201
        • Hospital Universitari Sant Joan de Reus
      • Santiago de Compostela, Spagna, 15706
        • Complejo Hospitalario Universitario de Santiago
      • Sevilla, Spagna, 41013
        • Hospital Universitario Virgen del Rocio
      • Sevilla, Spagna, 41007
        • Hospital Virgen de la Macarena
      • Torrevieja, Spagna, 03186
        • Hospital de Torrevieja
      • Valencia, Spagna, 46010
        • Hospital Clínico Universitario de Valencia
      • Valencia, Spagna, 46015
        • Hospital Arnau de Vilanova de Valencia
      • Zaragoza, Spagna, 50009
        • Hospital Universitario Lozano Blesa

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:

  • Written informed consent, specifically highlighting the molecular characterization of tumor and genomic samples
  • Age ≥18 years

  • Histologically confirmed invasive breast carcinoma, with all of the following characteristics:

    • Primary tumor ≥2cm in largest diameter (cT1-3)
    • cN0-1
    • No evidence of distant metastasis (M0)
  • Breast cancer (BC) eligible for primary surgery
  • Available pre-treatment core (Tru-cut) biopsy or possibility of performing one

  • HER2-negative BC (as per local assessment), defined as either of the following:

    • 0-1+ expression by IHC
    • 2+ expression by IHC and in situ hybridization (FISH/CISH) without HER2 gene amplification (<4 HER2 gene copies per nucleus, or a FISH ratio [HER2 gene copies to Cr17 signals] of <1.8)
    • Is situ hybridization (FISH/CISH) without HER2 gene amplification, independently of IHC
  • Known hormone receptor (ER/PgR) status (as per local assessment) or the possibility of performing the tests
  • Known percentage of hormone receptor (ER/PgR) and Ki67-positive tumor cells (as per local assessment), or possibility of performing the tests
  • In the case of a multifocal tumor, the largest lesion must be ≥2 cm and designated the "target" lesion for all subsequent tumor evaluations and HER2-negative status must be documented in all the tumor foci
  • ECOG performance status of 0 or 1

  • Laboratory values as follows:

    • Absolute neutrophil count (ANC) ≥1.5 x 109/L
    • Platelets count ≥100 x 109/L
    • Hemoglobin ≥9 g/dL
    • Serum bilirubin ≤1.5 time the upper limit of normal (ULN)
    • Alanine aminotransferase and aspartate aminotransferase (AST) ≤2.5 x ULN
    • Alkaline phosphatase ≤2.5 x ULN
    • Serum creatinine ≤1.5 mg/dL or calculated creatinine clearance ≥60 mL/m
  • Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
  • Ability and willingness to comply with study visits, treatment, testing, and to comply with the protocol
  • Availability of genomic DNA (via whole blood)

Exclusion Criteria:

  • Any prior treatment for primary invasive BC
  • Metastatic, locally advanced or inflammatory (i.e., Stage III-IV) BC
  • Bilateral invasive BC
  • Multicentric BC, defined as the presence of two or more foci of cancer in different quadrants of the same breast
  • Pre-existing peripheral neuropathy of any grade
  • Uncontrolled hypertension (systolic >150 mmHg and/or diastolic >100 mmHg)
  • Clinically significant (i.e., active) cardiovascular disease
  • Long QT syndrome
  • Concomitant use of inhibitors of hepatic transport proteins such as organic anion-transporting proteins, P-glycoprotein, multidrug resistant proteins etc
  • Major medical conditions that might affect study participation (e.g., uncontrolled seizure disorder, uncontrolled pulmonary, renal or hepatic dysfunction, or uncontrolled infection)
  • Other primary malignant tumors within the previous 5 years, except for adequately controlled limited basal cell carcinoma of the skin or carcinoma in situ of the cervix
  • Known human immunodeficiency virus(HIV) infection or other active or serious infection requiring IV antibiotics at randomization
  • Pregnancy or breastfeeding women
  • Women of childbearing potential(<2 years after the last menstruation) not using effective, non-hormonal means of contraception during the study and for a period of 6 months following the last administration of study drug
  • Administration of any live virus vaccine within 8 weeks preceding study entry
  • Use of any investigational agent within 30 days of administration of the first dose of study drug or concurrent treatment on another clinical study
  • Requirement for radiation therapy concurrent with study anticancer treatment
  • Known hypersensitivity to any of the study drugs or excipients
  • Inability or unwillingness to abide by the study protocol or cooperate fully with the investigator or designee

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

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Eribulin
1.23 mg/m2 eribulin ready to use solution (equivalent to 1.4 mg/m2 eribulin mesilate) IV on Days 1 and 8 of every 21-day cycle, for 4 cycles.
Droga: Eribulin
1.23 mg/m2 eribulin ready to use solution (equivalent to 1.4 mg/m2 eribulin mesilate) IV on Days 1 and 8 of every 21-day cycle, for 4 cycles.
Altri nomi:
  • Halaven(R)

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Correlation of pre-treatment relative abundance of hundreds of mRNA transcripts from primary breast tumors with pCRB after neoadjuvant treatment with eribulin.
Lasso di tempo: At the time of definitive surgery.
pCRB , defined as the complete absence of invasive carcinoma in the breast on histological examination at the time of definitive surgery, according to the NSABP guidelines
At the time of definitive surgery.

Misure di risultato secondarie

Misura del risultato
Lasso di tempo
Rate of pCRB, defined as the complete absence of invasive carcinoma in the breast on histological examination at the time of definitive surgery, according to the NSABP guidelines.
Lasso di tempo: At the time of definitive surgery
At the time of definitive surgery
Rate of pCRBL, defined as the complete absence of invasive carcinoma in the breast and axillary lymph nodes on histological examination at the time of definitive surgery.
Lasso di tempo: At the time of definitive surgery
At the time of definitive surgery
Clinical and radiological ORR, defined by RECIST 1.1
Lasso di tempo: At the time of definitive surgery
At the time of definitive surgery
Correlation of mRNA expression in breast tumors with clinical and radiological ORR at different time points during the neoadjuvant treatment with eribulin.
Lasso di tempo: Up to 21 weeks
Up to 21 weeks
Rate of pCRB according to breast cancer subtype: Luminal A, Luminal B, Basal-like, HER2-enriched and Claudin-low.
Lasso di tempo: At the time of definitive surgery
At the time of definitive surgery
Rate of pCRB according to breast cancer subtype determined by immunohistochemistry (following the 2011 St. Gallen definitions): Luminal A, Luminal B, and TNBC.
Lasso di tempo: At the time of definitive surgery
At the time of definitive surgery
Proportion of patients able to have breast conservation surgery after being treated with eribulin as neoadjuvant therapy.
Lasso di tempo: At the time of definitive surgery
At the time of definitive surgery
The correlation between alternations in tubulin isotype expression and mutational status in pre-treatment samples with efficacy parameters, such as pCRB, ORR and BOR.
Lasso di tempo: At the time of definitive surgery
At the time of definitive surgery
The correlation between exome or genome sequencing data from pre-treatment samples with pCRB after neoadjuvant treatment with eribulin.
Lasso di tempo: At the time of definitive surgery
At the time of definitive surgery
Changes in gene expression and gene mutational status between the pre-treatment samples and samples after treatment.
Lasso di tempo: At the time of definitive surgery
At the time of definitive surgery
Number of participants with AEs and serious AEs (assessed by CTCAE v.4)
Lasso di tempo: Up to 21 weeks
Up to 21 weeks
Percentage of patients who had neutropenia Grade 3-4
Lasso di tempo: Up to 21 weeks
Up to 21 weeks
Percentage of subjects with neuropathy
Lasso di tempo: Up to 21 weeks
Up to 21 weeks
Incidence of dose reductions and/or dose delays due to treatment toxicity
Lasso di tempo: Up to 71 days
Up to 71 days
Analysis of the expression of mRNA from breast tumors
Lasso di tempo: At screening
At screening
Analysis of the expression of mRNA from breast tumors
Lasso di tempo: At 21 days
At 21 days
Analysis of the expression of mRNA from breast tumors
Lasso di tempo: At the time of definitive surgery
At the time of definitive surgery
Correlation of mRNA expression in breast tumors after 21 days of neoadjuvant treatment and at surgery with pCRB.
Lasso di tempo: At the time of definitive surgery
At the time of definitive surgery
Sensitivity of the gene expression analysis of samples to predict clinical response to eribulin.
Lasso di tempo: At screening
At screening
Sensitivity of the gene expression analysis of samples to predict clinical response to eribulin.
Lasso di tempo: At 21 days
At 21 days
Sensitivity of the gene expression analysis of samples to predict clinical response to eribulin.
Lasso di tempo: At time of definitive surgery
At time of definitive surgery
Specificity of the gene expression analysis of samples to predict clinical response to eribulin.
Lasso di tempo: At screening
At screening
Specificity of the gene expression analysis of samples to predict clinical response to eribulin.
Lasso di tempo: At 21 days
At 21 days
Specificity of the gene expression analysis of samples to predict clinical response to eribulin.
Lasso di tempo: At time of definitive surgery
At time of definitive surgery

Collaboratori e investigatori

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

Sponsor

SOLTI Breast Cancer Research Group

Collaboratori

Eisai Inc.

Investigatori

  • Investigatore principale: Javier Cortés, MD, Hospital Universitario Vall d´Hebron
  • Investigatore principale: Aleix Prat, MD, Vall d´Hebron Institut d´Oncologia

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

  • Prat P, Llombart A, de la Peña L, Di Cosimo S, Oliveira M, Ortega V, Rubio I, Muñoz E, Harbeck N, Cortés J. NeoEribulin: A Phase II, non-randomized, open-label, single-arm, multicenter, exploratory pharmacogenomic study of single agent eribulin as neoadjuvant treatment for operable Stage I-II HER2 non-overexpressing breast cancer. Poster session presented at: 35th Annual San Antonio Breast Cancer Symposium (SABCS); 2012 December 4th-8th; San Antonio, Texas, United States.

Collegamenti utili

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 agosto 2012

Completamento primario (Effettivo)

1 giugno 2015

Completamento dello studio (Effettivo)

1 giugno 2015

Date di iscrizione allo studio

Primo inviato

9 agosto 2012

Primo inviato che soddisfa i criteri di controllo qualità

16 agosto 2012

Primo Inserito (Stima)

20 agosto 2012

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

6 novembre 2017

Ultimo aggiornamento inviato che soddisfa i criteri QC

31 ottobre 2017

Ultimo verificato

1 ottobre 2017

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • SOLTI-1007
  • 2012-000394-23 (Numero EudraCT)

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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