- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT03025711
Outcomes Of The Spanish Cohort Of Early Access To Pertuzumab And Trastuzumab Emtansine (KNOWHER)
Use Of Pertuzumab And Trastuzumab Emtansine In Adult Patients With Her2-Positive Metastatic Or Locally Recurrent Unresectable Breast Cancer
Aperçu de l'étude
Statut
Les conditions
Description détaillée
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.
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
-
-
-
Madrid, Espagne, 28222
- Puerta de Hierro University Hospital
-
-
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:
- 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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
---|
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
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Overall survival.
Délai: 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).
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Progression free survival.
Délai: 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
Délai: 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)
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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)
Délai: Through study completion, an average of 4 year
|
|
Through study completion, an average of 4 year
|
AEs of scientific interest
Délai: Through study completion, an average of 4 year
|
|
Through study completion, an average of 4 year
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Belén Ruiz-Antorán, PhD, Department of Clinical Pharmacology, University Hospital Puerta de Hierro Majadahonda, Madrid, Spain
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
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
- ML29844
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
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 Tumeurs mammaires
-
AstraZenecaRecrutementAdv Solid Malig - H&N SCC, ATM Pro / Def NSCLC, Gastric, Breast and Ovarian CancerEspagne, États-Unis, Belgique, Royaume-Uni, France, Hongrie, Canada, Corée, République de, Australie