Klinische Studie

A Phase III, Double-blind, Randomised Study to Assess Switching to AZD9833 (a Next Generation, Oral SERD) + CDK4/6 Inhibitor (Palbociclib or Abemaciclib) vs Continuing Aromatase Inhibitor (Letrozole or Anastrozole) + CDK4/6 Inhibitor in HR+/HER2- MBC Patients with Detectable ESR1 Mutation Without Disease Progression During 1L Treatment with Aromatase Inhibitor + CDK4/6 Inhibitor - A ctDNA Guided Early Switch Study(SERENA 6)Bewertung d. Umstellung auf AZD9833+CDK4/6-Inhib. gegenüber fortgesetzter AI+CDK4/6-Inhib. bei HR/HER2- MBC-Pat. mit ctDNA nachweisbarer ESR1-Mut. ohne Progression während der 1L-Behandlung
EUDRACT2021-000546-17
NCT-
DRKS-
Krankheitsentität(en) Brust
StudientypInterventionsstudiePhase III
Wesentliche Einschlusskriterien- Patient must be ≥ 18 years at the time of screening, or ≥ 20 years if in Japan - ICF1 must be signed and dated prior to initiation of the ESR1m Surveillance Period - Histologically confirmed diagnosis of ER+/HER2- breast cancer based on local laboratory results - Currently on treatment and have received ≥ 6 months (ie, 24 weeks) of AI (letrozole or anastrozole) + CDK4/6 inhibitor (palbociclib or abemaciclib) treatment as their initial endocrine based treatment for their metastatic disease in concordance with local palbociclib and abemaciclib label or treatment guideline - No evidence of clinical or radiological disease progression per investigator assessment
Wesentliche Ausschlusskriterien- Patient with known or family history of severe heart disease - Patients who are currently treated with endocrine therapy (AI, Tamoxifen or fulvestrant) alone or treated with ribociclib + endocrine therapy for their advanced disease irrespective of treatment duration - No evidence of disease, or bone only disease with sclerotic/osteoblastic bone lesions only (ie, no lytic or mixed lytic + sclerotic lesions) per standard of care imaging - Patients with CDK4/6 inhibitor treatment-induced symptomatic interstitial lung disease (Grade ≥ 2) - History of another primary malignancy
Statusrekrutierend
Ansprechpartner & KontaktCaritas-Krankenhaus St. Josef RegensburgFrauenheilkunde und Geburtshilfe Krankenhaus St JosefStudienzentrale0941 7823403fhk-studienzentrum(at)csj.de
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