- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT04133207
Clinical Outcome and Toxicity Data in Patients With Advanced Breast Cancer Treated With CDK Inhibitors Combined With Endocrine Therapy (HeCOG/CDKi)
Registry Study of Patients With Advanced Breast Cancer Treated With Cyclin-dependent Kinase 4/6 (CDK4/6) Inhibitors Combined With Endocrine Therapy: the Experience of the Hellenic Cooperative Oncology Group
Aperçu de l'étude
Statut
Les conditions
Description détaillée
Patients This will be a retrospective analysis of patients with histologically confirmed HR-positive, HER2-negative advanced (recurrent or metastatic) breast cancer. The investigators will use data from patients treated at Hellenic Cooperative Oncology Group (HeCOG)-affiliated departments of oncology. Eligible patients will be of 18 years or older, women of any menopausal status with HR-positive/HER2-negative advanced breast cancer who have received treatment with CDKi in combination with endocrine therapy for their advanced breast cancer. Treatment combinations of CDKi with any endocrine therapy will be accepted. Patients will be included in the analysis if they heve received at least two months of treatment with a CDKi. Patient clinical data will be obtained from their medical records. Toxicity data will be recorded from the clinicians' documentations during scheduled patient clinical visits.
Statistical analysis The primary endpoint of the study will be progression-free survival (PFS), defined as the time from treatment initiation to either the first documented disease progression or death from any cause. Secondary endpoint will be overall survival (OS), defined as the time from treatment initiation to patient death or last contact. Patients alive will be censored at the date of last contact. Adverse events will be graded based on Common Terminology Criteria for Adverse Events (CTCAE, version 4.0). Survival curves will be estimated using the Kaplan-Meier method and compared across groups with the log-rank test. The associations between the clinicopathological factors to be examined and the mortality rate will be evaluated with hazard ratios estimated with Cox proportional hazards model. The statistical analyses will be completed using the SAS software (SAS for Windows, version 9.3, SAS Institute Inc., Cary, NC).
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
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Athens, Grèce
- Hellenic Oncology Cooperative Group
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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:
- 18 years or older
- Αny menopausal status is allowed
- HR-positive/HER2-negative advanced breast cancer
- Patients treated with CDKi in combination with endocrine therapy for their advanced breast cancer
- Combinations of CDKi with any endocrine therapy are allowed
- More than two months of treatment with a CDKi is mandatory
Exclusion criteria:
• Treatment with CDKi as (neo)adjuvant treatment
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
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Patients with advanced HR-positive breast cancer
patients with histologically confirmed HR-positive, HER2-negative advanced (recurrent or metastatic) breast cancer.
Patients had been treated in Hellenic Cooperative Oncology Group (HeCOG)-affiliated departments of oncology
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
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Toxicity rates
Délai: Time Frame: through the completion of the study, up to 2 years
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Rates of adverse events from the combination of CDKi and endocrine therapy
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Time Frame: through the completion of the study, up to 2 years
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
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Overall Survival
Délai: Time Frame: from the date of treatment start until death from any cause or date of last contact whichever occurred first, assessed up to 60 months
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Overall survival was defined as the time from diagnosis until death from any cause or last follow-up
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Time Frame: from the date of treatment start until death from any cause or date of last contact whichever occurred first, assessed up to 60 months
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Collaborateurs et enquêteurs
Parrainer
Publications et liens utiles
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 (Réel)
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
- CDK-HeCOG-2019
Plan pour les données individuelles des participants (IPD)
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Informations sur les médicaments et les dispositifs, documents d'étude
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