Final Results from RIBBIT: A Randomized Phase III Study to Evaluate Efficacy and Quality of Life in Patients with Metastatic Hormone Receptor-Positive, HER2-Negative Breast Cancer Receiving Ribociclib in Combination with Endocrine Therapy or Chemotherapy with or without Bevacizumab in the First-Line Setting
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Le résumé fourni par la source
Background: We investigated the efficacy and health-related quality of life (HRQoL) in patients receiving either ribociclib plus endocrine therapy (ET) or chemotherapy with/without bevacizumab as first-line treatment of metastatic hormone receptor (HR)-positive, HER2-negative breast cancer (BC). Patients and Methods: In this randomized, phase III study (RIBBIT), 38 patients diagnosed with metastatic HR-positive, HER2-negative BC with presence of visceral metastases recruited between May 2018 and December 2020 were randomly assigned in a 1:1 ratio to either arm A (ribociclib + ET) or arm B (chemotherapy with/without bevacizumab) at 12 sites in Germany. The primary endpoint was progression-free survival (PFS). Secondary endpoints included overall response rate (ORR), overall survival (OS), patient-reported HRQoL, and frequency and type of adverse events. During study conduction, the recruitment rate was persistently and considerably lower than originally expected. Therefore, the recruitment was ended prematurely. The study was initially designed to enroll and randomize 158 patients. Results: = 2, 10.5%). The ORR [95% CI] between arm A (57.9% [33.5-79.7]) and arm B (52.6% [28.9-75.6]) was comparable. Median OS [95% CI] was not reached in arm A, while in arm B median OS was 28.4 months [25.0 - NA]. Patients in arm A reported less burden by side-effects. No new safety signals emerged. Conclusion: Treatment of patients with visceral metastatic HR-positive, HER2-negative BC with ribociclib in combination with ET showed a tendency toward a more favorable clinical outcome. Despite small numbers of patients and sites, this head-to-head comparison with chemotherapy supports the use of ribociclib with ET in patients with visceral metastasis at risk of fast disease progression.
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Le contrôle bibliographique ouvert
DOI retrouvé dans Crossref DOI retrouvé ; titre concordant.
- Titre Crossref
- Final Results from RIBBIT: A Randomized Phase III Study to Evaluate Efficacy and Quality of Life in Patients with Metastatic Hormone Receptor-Positive, HER2-Negative Breast Cancer Receiving Ribociclib in Combination with Endocrine Therapy or Chemotherapy with or without Bevacizumab in the First-Line Setting
- Date Crossref
- 20/12/2023
- Éditeur
- S. Karger AG
- Type
- journal-article
Ce recoupement confirme des métadonnées liées au DOI. Il ne confirme ni la méthode ni les conclusions de l’étude, et il ne compte pas comme une seconde source scientifique indépendante.
Où se fait cette recherche
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Ravensburg University of Cooperative Education pays non établi dans la noticeUniversité ou école supérieure
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Praxis für Hämatologie und Onkologie pays non établi dans la noticeÉtablissement de santé
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Iomedico (Germany) pays non établi dans la noticeEntreprise
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Klinikum Mittelbaden pays non établi dans la noticeÉtablissement de santé
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St.-Johannes-Hospital Dortmund pays non établi dans la noticeÉtablissement de santé
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Schwarzwald-Baar Klinikum pays non établi dans la noticeÉtablissement de santé
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Studienzentrum Onkologie pays non établi dans la noticeInstitution
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Praxis für interdisziplinäre Onkologie und Hämatologie pays non établi dans la noticeInstitution
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Department of Medicine pays non établi dans la noticeInstitution
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Onkologie Lerchenfeld pays non établi dans la noticeInstitution
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Department of Clinical Operations pays non établi dans la noticeÉtablissement de santé
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Department of Biostatistics pays non établi dans la noticeInstitution
Ravensburg University of Cooperative Education, Praxis für Hämatologie und Onkologie et Iomedico (Germany), avec 9 autres affiliations.
Une affiliation ne permet pas de déduire la nationalité d’un auteur.