Poster display session: Breast cancer - early stage, locally advanced & metastatic, CNS tumours, Developmental therapeutics, Genitourinary tumours - prostate & non-prostate, Palliative care, Psycho-oncology, Public health policy, Sarcoma, Supportive care

3881 - Real-world effectiveness of ribociclib + aromatase inhibitor, or endocrine monotherapy, or chemotherapy as first-line treatment in postmenopausal women with HR-positive, HER2-negative locally advanced or metastatic breast cancer: the RIBANNA study

Date

22 Oct 2018

Session

Poster display session: Breast cancer - early stage, locally advanced & metastatic, CNS tumours, Developmental therapeutics, Genitourinary tumours - prostate & non-prostate, Palliative care, Psycho-oncology, Public health policy, Sarcoma, Supportive care

Presenters

Peter A. Fasching

Citation

Annals of Oncology (2018) 29 (suppl_8): viii87-viii89. 10.1093/annonc/mdy271

Authors

P.A. Fasching¹, T. Decker², G. Guderian³, J. Heim⁴, C. Jackisch⁵, H. Lueck⁶, D. Lüftner⁷, F. Marmé⁸, T. Reimer⁹, A. Woeckel¹⁰

Author affiliations

¹ Comprehensive Cancer Centrer Erlangen-emn, Department Of Gynecology And Obstetrics, University Hospital Erlangen, 91054 - Erlangen/DE
² N.a., Onkologie Ravensburg, 88212 - Ravensburg/DE
³ Bu Oncology, Novartis Pharma Germany, 90429 - Nuremberg/DE
⁴ Bu Oncology, Novartis Pharma GmbH, 90429 - Nuremberg/DE
⁵ Obstetrics And Gynecology, Sana Klinikum, 63069 - Offenbach/DE
⁶ N.a., Gynökologisch-Onkologische Schwerpunktpraxis, Hannover/DE
⁷ Hematology And Oncology, Charité University Hospital, 12200 - Berlin/DE
⁸ National Center For Tumor Diseases And Department Of Obstetrics And Gynecology, University Hospital Heidelberg, 69120 - Heidelberg/DE
⁹ Klinikum Südstadt, University of Rostock, 18059 - Rostock/DE
¹⁰ Gynecology And Obstetrics, University Hospital Wuerzburg, 97080 - Wuerzburg/DE

Resources

Abstract 3881

Background

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.

Trial design

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

CLEE011ADE03.

Legal entity responsible for the study

Novartis Pharma GmbH.

Funding

Novartis Phrama GmbH.

Editorial Acknowledgement

Editorial assistance was provided by Product Lifecycle Services.

Disclosure

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.