ArticleBMJ open2022
Randomised, open-label, multicentric phase III trial to evaluate the safety and efficacy of palbociclib in combination with endocrine therapy, guided by ESR1 mutation monitoring in oestrogen receptor-positive, HER2-negative metastatic breast cancer patients: study design of PADA-1.
Article in BMJ open, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03079011 (Randomized, Open Label, Multicentric Phase III Trial to Evaluate the Safety and Efficacy of Palbociclib in Combination With HT Driven by ctDNA ESR1 Mutation Monitoring in ER+, HER2-negative Metastatic Breast Cancer Patients), which is not on this map. Cited by 30 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.
The trial behind it
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.
Randomized, Open Label, Multicentric Phase III Trial to Evaluate the Safety and Efficacy of Palbociclib in Combination With HT Driven by ctDNA ESR1 Mutation Monitoring in ER+, HER2-negative Metastatic Breast Cancer Patients
Who cites it
30 citing papers in PubMed, 1 synthesis or guideline pooled it, 43 citations in OpenAlex.
- 6th and 7th International consensus guidelines for the management of advanced breast cancer (ABC guidelines 6 and 7).Breast (Edinburgh, Scotland) · 2024Guideline
- Next-generation endocrine therapy in HR+/HER2 - breast cancer: oral SERDs, ER-targeting innovations, and ctDNA-driven ESR1 mutation-guided switching.Breast cancer (Tokyo, Japan) · 2026Review
- New perspectives on endocrine therapy suitability for hormone receptor-positive metastatic breast cancer in clinical practice.Breast (Edinburgh, Scotland) · 2026Review
- Evolving First-Line Endocrine Therapy in HR+/HER2- Metastatic Breast Cancer: CDK4/6 Inhibition, Biomarker-Guided Strategies and Emerging Therapeutic Paradigms.Current oncology (Toronto, Ont.) · 2026Review
- Causality between immune cells and HER2-breast cancer: A 2‑sample Mendelian randomization study.Medicine · 2026Article
- From detection to action: ctDNA-MRD surveillance and translational strategies in early breast cancer.Frontiers in oncology · 2026Review
- Liquid Biopsy and Multi-Omic Biomarkers in Breast Cancer: Innovations in Early Detection, Therapy Guidance, and Disease Monitoring.Biomedicines · 2025Review
- Navigating Treatment Sequencing in Advanced HR+/HER2- Breast Cancer After CDK4/6 Inhibitors: Biomarker-Driven Strategies and Emerging Therapies.International journal of molecular sciences · 2025Review
- MyClone: rapid and precise reconstruction of clonal population structures for tumors.BMC bioinformatics · 2025Article
- Detection rate for ESR1 mutations is higher in circulating-tumor-cell-derived genomic DNA than in paired plasma cell-free DNA samples as revealed by ddPCR.Molecular oncology · 2025Article
- The expression of epidermal growth factor receptor 2 and its relationship with tumor-infiltrating lymphocytes and clinical pathological features in breast cancer patients.Open life sciences · 2025Article
- Perspectives for the clinical application of ctDNA analysis to breast cancer drug therapy.Breast cancer (Tokyo, Japan) · 2025Review
- Exploring breast cancer associated-gene panel for next-generation sequencing and identifying new, pathogenic variants in breast cancer from western China.Journal of Cancer · 2025Article
- Molecular Profiling of Endocrine Resistance in HR+/HER2-Metastatic Breast Cancer: Insights from Extracellular Vesicles-Derived DNA and ctDNA in Liquid Biopsies.International journal of molecular sciences · 2024Article
- Multiplex detection of tenThe journal of liquid biopsy · 2024Article
- Palbociclib: Randomized Studies and Real-world Evidence as the Basis for Therapeutic Planning in Metastatic Breast Cancer.Geburtshilfe und Frauenheilkunde · 2024Article
- Circulating tumor DNA: from discovery to clinical application in breast cancer.Frontiers in immunology · 2024Review
- Circulating Tumor DNA Is a Variant of Liquid Biopsy with Predictive and Prognostic Clinical Value in Breast Cancer Patients.International journal of molecular sciences · 2023Review
- Liquid biopsies and those three little words: finding the perfect match for the MTB.Medizinische Genetik : Mitteilungsblatt des Berufsverbandes Medizinische Genetik e.V · 2023Article
- Review
Corrections and comments
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Authors and funding
16 authors at 12 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionThe combination of a CDK4/6 inhibitor with an aromatase inhibitor (AI) has recently become the gold standard for AI-sensitive first line treatment of oestrogen receptor-positive (ER+) HER2-negative (HER2-) advanced breast cancer. However, most patients receiving this combination will ultimately progress and require further therapies.Several studies have demonstrated that the onset of a
methodsPADA-1 is a randomised, open-label, multicentric, phase III trial conducted in patients receiving AI and palbociclib as first line therapy for metastatic ER +HER2- breast cancer. 1000 patients will be included and treated with palbociclib in combination with an AI. Patients will be screened for circulating blood ETHICS AND DISSEMINATION: The study has been approved by the French medicines agency (ANSM) and by an ethics committee (ref 01/17_1 CPP Ouest-IV Nantes) in January 2017. The trial results will be published in academic conference presentations and international peer-reviewed journals. TRIAL REGISTRATION NUMBERS: EudraCT: 2016-004360-18; NCT03079011.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.