This non-interventional observational study evaluates the real-world effectiveness and safety profile of ribociclib in combination with an aromatase inhibitor for adjuvant treatment in patients with HR+/HER2- early breast cancer at high risk of recurrence, as well as patient compliance and quality of life.
Histological diagnosis of HR+/HER2- early breast cancer with curative intent
Patients must have an indication for a treatment with ribociclib + AI ± LHRH as described in the current SmPC/"Fachinformation" of ribociclib (to be included into the cohorts of ribociclib + AI ± LHRH and ET mono ± LHRH) or abemaciclib + ET ± LHRH as described in the current SmPC/"Fachinformation" of abemaciclib (to be included into the abemaciclib + ET ± LHRH cohort) in the adjuvant setting
Before enrollment the treating physician has made the decision in accordance with the patient to treat the patient with either
ribociclib + AI ± LHRH, or
None
Adult female and male patients with an indication for adjuvant treatment with ribociclib + AI ± LHRH (or abemaciclib + ET ± LHRH for the abemaciclib cohort) in HR+/HER2- eBC at high risk of recurrence as described in the current effective summary of product characteristics enrolled from specialized centers, hospitals and outpatient centers.
Cohort
Prospective
ribociclib + AI ± LHRH
Drugribociclib in combination with an aromatase inhibitor ± LHRH as described in the current effective summary of product characteristics. This is an observational study. There is no treatment allocation. The decision to initiate treatment will be based solely on clinical judgement.
abemaciclib + ET ± LHRH
Drugabemaciclib in combination with an endocrine therapy ± LHRH as described in the current effective summary of product characteristics. This is an observational study. There is no treatment allocation. The decision to initiate treatment will be based solely on clinical judgement.
ET mono ± LHRH
Drugendocrine monotherapy ± LHRH. This is an observational study. There is no treatment allocation. The decision to initiate treatment will be based solely on clinical judgement.
Invasive disease-free survival (iDFS) for adjuvant therapy with ribociclib + AI ± LHRH in participants with HR+/HER2- eBC at high risk of recurrence
iDFS using STEEP (Standardized Definitions for Efficacy Endpoints in Adjuvant Breast Cancer Trials) criteria, as assessed by the investigator. iDFS is defined as the time from study start to the date of the first event of invasive ipsilateral breast tumor recurrence, local/regional invasive recurrence, distant recurrence, death (any cause), contralateral invasive BC, or second primary non-breast invasive cancer (excluding basal and squamous cell carcinomas of the skin).
Number of participants per Baseline parameters
Description of available baseline characteristics (e.g. medical history, gender, menopausal status, disease characteristics, laboratory values, socio-economic status, genetic profile, etc.) by treatment cohorts
Reasons for treatment decision by treating physician
Reason for treatment decision documented by the treating physician
Patients' individual perception of risk of recurrence and treatment decision
Patients' individual perception of risk of recurrence and treatment decision assessed by questionnaire at baseline. The questionnaire is provided in two versions, with one version containing 6 items (applicable for the ET mono cohort), and the other version containing 11 items (applicable for ribociclib and abemaciclib cohorts). Responses are primarily given by selecting from predefined options, with some questions allowing multiple answers or prioritization. The scales and response options are designed to reflect individual preferences, concerns, and decision-making processes of patients. Higher scores on the importance scale indicate a stronger motivation to reduce recurrence risk
Invasive disease-free survival (iDFS) (ribociclib cohort)
iDFS using STEEP criteria. iDFS is defined as the time from study start to the date of the first event of invasive ipsilateral breast tumor recurrence, local/regional invasive recurrence, distant recurrence, death (any cause), contralateral invasive BC, or second primary non-breast invasive cancer (excluding basal and squamous cell carcinomas of the skin).
Click on the lead sponsor to view all of their trials.
