Un estudio de ribociclib en combinación con terapia hormonal en el cáncer de mama metastásico o avanzado HR + / HER2
Estudio de evidencia del mundo real sobre la seguridad y eficacia de ribociclib en combinación con terapia hormonal en pacientes con cáncer de mama avanzado o metastásico HR+/HER2- en la región de Medio Oriente
This is a non-interventional, ambispective, observational cohort study describing the real-world safety data of approximately 550 Hormone receptor / Human epidermal growth factor receptor 2 (HR+/HER2-) advanced/metastatic breast cancer patients who have received ribociclib combined with hormonal therapy in pre-and postmenopausal women or men in Middle Eastern countries.
Descripción general del estudio
Descripción detallada
The investigators will have a six-month recruitment period to include the eligible subjects as per the protocol selection criteria. Retrospective patients should have been on Ribociclib in combination with hormonal therapy for at least 18 months and stopped the medication before the patient's recruitment.
Ambispective patients should have initiated Ribociclib, in combination with hormonal therapy, for at least 12 months before the patient's recruitment date and are still on Ribociclib in combination with hormonal therapy at recruitment. These patients will be followed up till progression, death, Ribociclib discontinuation due to adverse events, or till a maximum period of 6 months, whichever comes first.
Data will be collected from patient electronic medical records in the sites chosen for patients who received Ribociclib, in combination with hormonal therapy, in the first or second-line setting available in the relevant institutions.
A total of 550 patients is planned for this study. The planned sample size should capture very common adverse events reported in previous studies as well as adverse events ≥ 10% occurring in grade 3 and grade 4 with precision ±2.5%.
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Al Ain Abu Dhabi, Emiratos Árabes Unidos
- Novartis Investigative Site
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Amman, Jordán, 11941
- Novartis Investigative Site
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Muscat, Omán, 111
- Novartis Investigative Site
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
HR+/HER2- advanced/metastatic breast cancer patients who have received Ribociclib in combination with hormonal therapy in pre-and postmenopausal women or men in Middle Eastern countries
Descripción
Inclusion Criteria:
- Adult patients ≥ 18 years old at the time of receiving Ribociclib in combination with hormonal therapy.
- Advanced /metastatic breast cancer
- Estrogen-receptor-positive and/or progesterone receptor-positive breast cancer.
- HER2-negative breast cancer.
- Patients who received or currently receiving Ribociclib in combination with hormonal therapy in the first or second-line settings as per the routine practice.
- For the ambispective part, patients should have initiated the Ribociclib, in combination with hormonal therapy, line of treatment at least 12 months before the patient's recruitment date and still continuingcontinuing the drug at the baseline visit.
- For retrospective patients only, the patients should have been on Ribocilib, in combination with hormonal therapy, for at least 18 months and stopped Ribociclib before the SIV date.enrollment
- For ambispective part, patients agree to sign informed consent before their enrollment.
Exclusion Criteria:
- Ribociclib-based treatment regimen beyond the second line.
- Patients are currently participating in any other clinical trials.
- Patient with a known hypersensitivity to any of the excipients of Ribociclib.
- Patients who previously received any other CDK4/6 inhibitor .
- For ambispective patients, patients who refuse to sign the informed consent
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: COHORT
- Perspectivas temporales: OTHER
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
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ribociclib ambispective
Ambispective patients should have initiated Ribociclib, in combination with hormonal therapy, for at least 12 months before the patient's recruitment date and are still on Ribociclib in combination with hormonal therapy at recruitment. These patients will be followed up till progression, death, Ribociclib discontinuation due to adverse events, or till a maximum period of 6 months, whichever comes first. |
There is no treatment allocation for NIS trials, patients on administered ribociclib by prescription will be enrolled. Treatment plan represents the prescription.
Otros nombres:
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ribociclib retrospective
Retrospective patients should have been on Ribociclib in combination with hormonal therapy for at least 18 months and stopped the medication before the patient's recruitment |
There is no treatment allocation for NIS trials, patients on administered ribociclib by prescription will be enrolled. Treatment plan represents the prescription.
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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AEs/SAEs/ severity and frequency
Periodo de tiempo: 18 months
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Frequency/ severity of adverse events and lab abnormalities of HR+/HER2- advanced/metastatic breast cancer patients who have received Ribociclib in combination with hormonal therapy at 6and 18 months. |
18 months
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Proportion of patients who are progression-free
Periodo de tiempo: 6 months, 18 months
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Percentage of progression-free patients (at 18 months following the start date of ribociclib and at the end of ribociclib treatment), |
6 months, 18 months
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Proportion of patients with clinical benefit response
Periodo de tiempo: 18 months
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Tthe proportion of patients who have a partial or complete response or stable disease(CBR) with Ribociclib at 18 months based on Response Evaluation Criteria in Solid Tumors RECIST v1.1 |
18 months
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Ribociclib line of therapy treatment pattern
Periodo de tiempo: 18 months
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Ribociclib line of therapy treatment pattern at 18 months |
18 months
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Director de estudio: Novartis Pharmaceuticals, Novartis Pharmaceuticals
Publicaciones y enlaces útiles
Enlaces Útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- CLEE011AIC01
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
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