Questa pagina è stata tradotta automaticamente e l'accuratezza della traduzione non è garantita. Si prega di fare riferimento al Versione inglese per un testo di partenza.

Outcomes Of The Spanish Cohort Of Early Access To Pertuzumab And Trastuzumab Emtansine (KNOWHER)

4 marzo 2020 aggiornato da: BELEN RUIZ-ANTORAN

Use Of Pertuzumab And Trastuzumab Emtansine In Adult Patients With Her2-Positive Metastatic Or Locally Recurrent Unresectable Breast Cancer

The overall study objective is to evaluate the effectiveness and safety of Trastuzumab emtansine (T-DM1) and Pertuzumab under real-world disease conditions in the Spain, and specifically in patients treated under compassionate use or early access program

Panoramica dello studio

Stato

Completato

Condizioni

Descrizione dettagliata

This is a retrospective, non-interventional, non-comparative, observational cohort study / registry in the Spain. The study design will reflect real-life clinical management of patients with HER2-positive MBC. Type and frequency of actual patient visits and all evaluations will be done as for routine clinical practice.

The analysis of the efficacy and safety results obtained in patients receiving pertuzumab or TDM1 in those early access systems is of utmost importance. These real-world patients with advanced breast cancer may have different characteristics than those enrolled in clinical trials and clinicians must often extrapolate into therapeutic decisions not fully supported by a robust evidence.

Tipo di studio

Osservativo

Iscrizione (Effettivo)

220

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

  • Spagna
      • Madrid, Spagna, 28222
        • Puerta de Hierro University Hospital

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

Da 18 anni a 100 anni (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

This study will include a cohort of approximately 700 adult patients from the Spain with HER2-positive metastatic or locally recurrent unresectable breast cancer and who are treated with Trastuzumab emtansine (T-DM1) or Pertuzumab under compassionate use or early access program. The decision to initiate use of Trastuzumab emtansine (T-DM1) and Pertuzumab is made independently by the participant and their health care provider and is not mandated by the study design or protocol.

Descrizione

Inclusion Criteria:

  • Adult patients (age ≥ 18 years at enrolment) with HER2-positive metastatic or locally recurrent unresectable breast cancer and who are treated with Trastuzumab emtansine (T-DM1) or Pertuzumab.
  • Patients who initiate Trastuzumab emtansine (T-DM1) and Pertuzumab under Spanish compassionate use or early access program.

Exclusion Criteria:

  • Given the characteristics of the study there are no exclusion criteria.

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

Coorti e interventi

Gruppo / Coorte
Pertuzumab
Patients with HER2-positive metastatic or locally recurrent unresectable breast cancer and who are treated with Pertuzumab under Spanish compassionate use or early access program
Trastuzumab emtansine
Patients with HER2-positive metastatic or locally recurrent unresectable breast cancer and who are treated with Trastuzumab emtansine (T-DM1) under Spanish compassionate use or early access program

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Overall survival.
Lasso di tempo: Through study completion (from date of start of treatment until the date of death from any cause, assessed up to 48 months).
The time between the date of start of treatment and the date of death. For subjects without documentation of death, OS will be censored on the last date the subject was known to be alive
Through study completion (from date of start of treatment until the date of death from any cause, assessed up to 48 months).

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Progression free survival.
Lasso di tempo: Through study completion (from date of start of treatment until the date of first documented progression assessed up to 48 months)
The time from start of treatment to the date of the first documented tumour progression as determined by the clinician (may be based on clinical examination or radiographic or laboratory features).
Through study completion (from date of start of treatment until the date of first documented progression assessed up to 48 months)
Best overall response rate
Lasso di tempo: Through study completion, an average of 4 year
Response rate is defined as the proportion of patients with complete response (CR) or partial response (PR) based on their best overall response as written in the medical record
Through study completion, an average of 4 year
Duration of response (DOR)
Lasso di tempo: Through study completion, an average of 4 year
The time between the date of first confirmed response to the date of the first documented tumour progression, or death due to any cause, whichever occurs first. At the time of the analysis, several limitations should be taken into consideration for this retrospective study: DOR is only appraisable if measurable disease and DOR data availability in the medical records (ideally assessed with the RECIST criteria) could be incomplete.
Through study completion, an average of 4 year
Time to treatment failure
Lasso di tempo: Through study completion (from date of start of treatment until the date of treatment failure, assessed up to 48 months)
Through study completion (from date of start of treatment until the date of treatment failure, assessed up to 48 months)
Time to Objective Response
Lasso di tempo: Through study completion (from date of start of treatment until the date of the first confirmed response, assessed up to 48 months)
The time from start of treatment to the date of the first confirmed response (evaluated for responders only)
Through study completion (from date of start of treatment until the date of the first confirmed response, assessed up to 48 months)
Time to change treatment
Lasso di tempo: Through study completion (from date of start of treatment until the date of change treatment, assessed up to 48 months)
Through study completion (from date of start of treatment until the date of change treatment, assessed up to 48 months)
Time to next treatment
Lasso di tempo: Through study completion (from date of start of treatment until the date of start other treatment, assessed up to 48 months)
Through study completion (from date of start of treatment until the date of start other treatment, assessed up to 48 months)
All suspected Grade 3/4/5 adverse reactions
Lasso di tempo: Through study completion, an average of 4 year
Through study completion, an average of 4 year
Adverse events of special interest to anti HER2 Mab (AESI)
Lasso di tempo: Through study completion, an average of 4 year
  • AESIs regarding treatment with T-DM1: Hepatic disorder (specific analytical alteration)
  • AESIs regarding treatment with Pertuzumab: Interstitial Lung Disease
Through study completion, an average of 4 year
AEs of scientific interest
Lasso di tempo: Through study completion, an average of 4 year
  • An asymptomatic decline in LVEF requiring treatment or leading to discontinuation of study treatment (regarding treatment with T-DM1 and Pertuzumab)
  • Other AEs leading to treatment discontinuation
Through study completion, an average of 4 year

Collaboratori e investigatori

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

Sponsor

BELEN RUIZ-ANTORAN

Investigatori

  • Investigatore principale: Belén Ruiz-Antorán, PhD, Department of Clinical Pharmacology, University Hospital Puerta de Hierro Majadahonda, Madrid, Spain

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 (Effettivo)

1 dicembre 2017

Completamento primario (Effettivo)

1 ottobre 2018

Completamento dello studio (Effettivo)

31 gennaio 2020

Date di iscrizione allo studio

Primo inviato

11 gennaio 2017

Primo inviato che soddisfa i criteri di controllo qualità

16 gennaio 2017

Primo Inserito (Stima)

19 gennaio 2017

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

5 marzo 2020

Ultimo aggiornamento inviato che soddisfa i criteri QC

4 marzo 2020

Ultimo verificato

1 marzo 2020

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • ML29844

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

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 .

Prove cliniche su Neoplasie mammarie

Cerca prove simili

Sponsor e collaboratori

Condizioni mediche

Interventi farmacologici

CROs by country

CROs in Georgia

Condizioni

Malattie rare

Interventi farmacologici

Supplementi dietetici

Sponsor / Collaboratori

Sedi

Sottoscrivi