Trial reportBreast (Edinburgh, Scotland)2020
Initial experience with CDK4/6 inhibitor-based therapies compared to antihormone monotherapies in routine clinical use in patients with hormone receptor positive, HER2 negative breast cancer - Data from the PRAEGNANT research network for the first 2 years of drug availability in Germany.
Trial report in Breast (Edinburgh, Scotland), 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 38 papers, 1 of them a synthesis that pooled it.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
38 citing papers in PubMed, 1 synthesis or guideline pooled it, 55 citations in OpenAlex.
- Efficacy and Safety of Cyclin-Dependent Kinase 4/6 Inhibitors in Patients with Breast Cancer: A Systematic Review and Meta-analysis of Randomized Controlled Trials and Real-World Studies.Targeted oncology · 2025Pooled it
- Fulvestrant versus capecitabine as maintenance therapy in hormone receptor-positive, HER2-negative metastatic breast cancer after first-line chemotherapy (FAMILY): a multicenter, open-label, randomized, phase 3 trial.Signal transduction and targeted therapy · 2026Trial
- Anti-hormonal maintenance treatment with the CDK4/6 inhibitor ribociclib after 1st line chemotherapy in hormone receptor positive / HER2 negative metastatic breast cancer: A phase II trial (AMICA).Breast (Edinburgh, Scotland) · 2023Trial
- A real-world study of the first use of palbociclib for the treatment of advanced breast cancer within the UK National Health Service as part of the novel Ibrance® Patient Program.British journal of cancer · 2023Trial
- Abemaciclib in HR+, HER2- Breast Cancer: A Narrative Review of the Clinical Evidence.Oncology and therapy · 2026Review
- CDK4/6 inhibitor combined with endocrine therapy: a real-world evaluation of efficacy and safety in HR+/HER2- advanced breast cancer.World journal of surgical oncology · 2026Article
- PARP inhibition with olaparib and talazoparib for HER2-negative advanced breast cancer-Results from the prospective PRAEGNANT registry.NPJ breast cancer · 2026Article
- The efficacy and therapy management of nab-paclitaxel in the real-world setting for patients with advanced breast cancer - the SERAPHINA study.Journal of cancer research and clinical oncology · 2025Observational
- Review
- Treatment sequences and survival outcomes in advanced HR + HER2- breast cancer patients: a real-world cohort.Breast cancer research and treatment · 2025Article
- Local Control of Advanced Breast Cancer-Debate in Multidisciplinary Tumor Board.Journal of clinical medicine · 2025Article
- Underserved Patient Populations With Metastatic Breast Cancer: A Review of Progress and Remaining Challenges.The breast journal · 2025Review
- Article
- Timing of Dose Reductions and Survival Outcomes in Metastatic Breast Cancer Patients Treated with Cyclin-Dependent Kinase 4/6 Inhibitors.Current oncology (Toronto, Ont.) · 2024Article
- Real-World Data with CDK4/6 Inhibitors-A Single Center Experience from Croatia.Journal of personalized medicine · 2024Article
- Update Breast Cancer 2024 Part 1 - Expert Opinion on Advanced Breast Cancer.Geburtshilfe und Frauenheilkunde · 2024Article
- CDK4/6 Inhibition - Therapy Sequences and the Quest to Find the Best Biomarkers - an Overview of Current Programs.Geburtshilfe und Frauenheilkunde · 2024Article
- Real-World Data Analysis of CDK4/6 Inhibitor Therapy-A Patient-Centric Single Center Study.Cancers · 2024Article
- Attrition in the First Three Therapy Lines in Patients with Advanced Breast Cancer in the German Real-World PRAEGNANT Registry.Geburtshilfe und Frauenheilkunde · 2024Article
- Treatment patterns of patients with HR+/HER2- metastatic breast cancer receiving CDK4/6 inhibitor-based regimens: a cohort study in the French nationwide healthcare database.Breast cancer research and treatment · 2024Article
Corrections and comments
- Erratum issued
Authors and funding
34 authors at 20 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeTreatment with CDK4/6 inhibitors and endocrine therapy (CDK4/6i + ET) is a standard for patients with advanced hormone receptor-positive, HER2-negative (HR + HER2-) breast cancer (BC). However, real-world data on the implementation of therapy usage, efficacy, and toxicity have not yet been reported.
methodsThe PRAEGNANT registry was used to identify advanced HR + HER2- BC patients (n = 1136). The use of chemotherapy, ET, everolimus + ET, and CDK4/6i + ET was analyzed for first-line, second-line, and third-line therapy. Progression-free survival (PFS) and overall survival (OS) were also compared between patients treated with CDK4/6i + ET and ET monotherapy. Also toxicity was assessed.
resultsCDK4/6i + ET use increased from 38.5% to 62.7% in the first 2 years after CDK4/6i treatment became available (November 2016). Chemotherapy and ET monotherapy use decreased from 2015 to 2018 from 42.2% to 27.2% and from 53% to 9.5%, respectively. In this early analysis no statistically significant differences were found comparing CDK4/6i + ET and ET monotherapy patients with regard to PFS and OS. Leukopenia was was seen in 11.3% of patients under CDK4/6i + ET and 0.5% under ET monotherapy.
conclusionsIn clinical practice, CDK4/6i + ET has been rapidly implemented. A group of patients with a more unfavorable prognosis was possibly treated in the real-world setting than in the reported randomized clinical trials. The available data suggest that longer follow-up times and a larger sample size are required in order to identify differences in survival outcomes. Studies should be supported that investigate whether chemotherapy can be avoided or delayed in this patient population by using CDK4/6i + ET.
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