a non-interventional study for kisqali (ribociclib) in combination with an aromatase inhibitor for adjuvant treatment in patients with hr+/her2- early breast cancer at high risk of recurrence

Conditions: Breast Neoplasms

Summary: 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.

this non-interventional study aims to provide information on real-world effectiveness, safety and tolerability, management of adverse events, qol and patient compliance of patients with hr+/her2- early breast cancer at high risk of recurrence treated with ribociclib in combination with an non-steroidal aromatase inhibitor (nsai) ± luteinizing hormone-releasing hormone (lhrh) with curative intent according to the german summary of product characteristics. in order to put the results of patients treated with ribociclib into perspective, socio-economic data, data on qol and patient compliance will also be collected from patients treated with abemaciclib + endocrine therapy (et) ± lhrh as described in the respective local summary of product characteristics. to understand reasons for treatment decision, and to analyze the clinical adoption of ribociclib + nsai ± lhrh after eu approval over time, baseline data will be collected from cohorts of ribociclib + nsai ± lhrh, abemaciclib + et ± lhrh, and additionally from patients treated with et monotherapy ± lhrh and analyzed cross-sectionally. the study is planned to be rolled out into a broad set of german and optionally austrian and swiss breast centers and gynecological practices to describe clinical routine in a representative subset of the local healthcare eco-system. it will gather insights into the potential benefits and risks associated with ribociclib + nsai ± lhrh in the adjuvant treatment of hr+/her2- ebc patients at high risk of recurrence. this knowledge will inform about clinical decision-making and contribute to improved patient outcomes in routine practice.

Eligibility criteria:
inclusion criteria: * histological diagnosis of hr+/her2- early breast cancer with curative intent * patients must have an indication for a treatment with ribociclib + nsai ± lhrh as described in the current smpc/"fachinformation" of ribociclib (to be included into the cohorts of ribociclib + nsai ± 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 + nsai ± lhrh, or * et mono ± lhrh, or * abemaciclib + et ± lhrh and baseline is no longer than 2 weeks (14 days) prior to written informed consent for this study. baseline = for ribociclib + nsai ± lhrh cohort: date of therapy start; for abemaciclib + et ± lhrh cohort: date of therapy start; for et mono ± lhrh cohort: 4 weeks after therapy start or 4 weeks after last non-endocrine based therapy, whichever is last. * ≥18 years of age * written informed consent exclusion criteria: * patient is currently under active treatment in any investigational trial or simultaneously participating in another novartis-sponsored non-interventional study with ribociclib * for ribociclib + nsai ± lhrh cohort: et pre-treatment is longer than 12 months, according to the current smpc/"fachinformation" of ribociclib; for abemaciclib + et ± lhrh cohort: et pre-treatment is longer than 12 weeks, according to the current smpc/"fachinformation" of abemaciclib

Keywords: non-interventional study nis breast cancer early breast cancer hr+ her- ribociclib real world evidence adjuvant therapy