In the double blind, placebo-controlled phase III MONALEESA-2 trial, the selective CDK4/6 inhibitor ribociclib in combination with letrozole significantly prolonged progression free survival (PFS) in patients who were treatment-naïve for HR+/HER2- advanced breast cancer (aBC). In 2017, Ribociclib was approved in combination with an aromatase inhibitor (AI) for the treatment of HR+/HER2- aBC (locally advanced or metastatic). However, real-world evidence for the effectiveness, safety and tolerability of ribociclib+AI in routine clinical practice is needed to further support its use.
RIBANNA is a non-interventional study (NIS) running in Germany since Oct 2017. Up to 400 German sites are expected to enroll 3020 postmenopausal patients receiving ribociclib+AI, or endocrine monotherapy, or chemotherapy as first-line treatment for HR+/HER2- aBC. Data will be collected from clinical practice on the effectiveness, safety, tolerability, and duration of therapy, including impact on quality of life (QoL) in all three cohorts prescribed in line with the respective German prescribing guidelines. These data and the corresponding outcomes will be described for the three different cohorts. Further lines of treatment will also be documented in RIBANNA to gain insight into the outcome of sequential therapy. For this purpose, patients will be documented for up to 7 years in total. In addition, RIBANNA will collect information on QoL using validated patient reported outcome measures to assess the impact of routine ribociclib+AI treatment, endocrine monotherapy or chemotherapy. The RIBANNA study will provide the first real-world evidence regarding the treatment of HR+/HER2- aBC/mBC with the novel CDK4/6 inhibitor ribociclib, including insights into treatment regimen, sequence of therapies and impact on QoL.
Clinical trial identification
Legal entity responsible for the study
Novartis Pharma GmbH.
Novartis Phrama GmbH.
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P.A. Fasching: Consulting: Amgen, Roche, Novartis, Pfizer, Roche, Celgene; Fees: Amgen, Roche, Novartis, Pfizer, Roche, Celgene; Research funding: Novartis, Pfizer, Celgene. T. Decker: Consulting: Novartis; Support for travel fees: Novartis. J. Heim: Employee: Novartis Pharma GmbH. C. Jackisch: Employee: Sana Klinikum Offenbach; Consulting: Roche Pharma AG, Genomic Health; Research funding: Novartis Pharma, Roche, AstraZeneca, Genomic Health. H-J. Lueck: Consulting: Roche, Tesaro, Novartis, Astrazeneca, Lilly, Pfizer; Fees: Pfizer, Astrazeneca, Tesaro, Novartis, Roche. D. Lüftner: Consulting: Novartis, Pfizer, Eli Lilly, Celgene, Loreal, AstraZeneca; Fees: Novartis, Pfizer, Eli Lilly, Celgene, Loreal, AstraZeneca. F. Marmé: Consulting: Novartis, Pfizer, AstraZeneca, Roche, Amgen, Celgene; Fees: Novartis, Pfizer, AstraZeneca, Roche, Amgen, Genomic Health, PharmaMar, Celgene, MSD. T. Reimer: Consultant: Department of Obstetrics and Gynecology, University of Rostock, Germany; Fees: Roche, Novartis, Amgen, Pfizer, AstraZeneca. A. Woeckel: Clinic Director; Fees: GSK, Pfizer, Novartis, Amgen, Jannsen-Cilag, Celgene, Hexal, Roche; Research funding: Roche.