Initial Oral Vinorelbine Dosing Schedules in Clinical Routine in Germany and Austria (StepUp)
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The aim of this non-interventional study is to assess oral vinorelbine dose schedules (initial dose, dose increase/maintenance/reduction) applied during the initial 8 weeks of treatment under routine conditions in Germany together with the underlying reasons for the respective chosen schedules.
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Layout table for eligibility information
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Palliative patients with advanced non-small-cell lung cancer (NSCLC, stage III and IV) or anthracycline/taxane-resistant metastatic breast cancer (MBC, stage IV)
Written informed consent of the patient with regard to the pseudonymized documentation and processing of his/her disease data
Legally capable male or female NSCLC patient or legally capable female MBC patient; in both situations: ≥ 18 years of age (no upper limit)
Presence of any of the following two tumor entities:
Advanced NSCLC (stage III or IV)
Anthracycline- and taxane-resistant MBC (stage IV) in women
Planned systemic chemotherapy and planned regimen with oral vinorelbine in any palliative setting (decision on treatment must have been made before inclusion in this study); included treatments:
Monotherapy or any combination therapy with oral vinorelbine
Inclusion of patients with hybrid-treatment involving i.v. and oral vinorelbine in one treatment cycle is allowed
Presence of any contraindication with regard to oral vinorelbine treatment (and with regard to i.v. vinorelbine in case of hybrid-treatment) according to the respective Summary of Product Characteristics (SmPC)
Oral vinorelbine based palliative treatment already ongoing or planned oral vinorelbine starting dose of >60 mg/m2
Presence of a Eastern Cooperative Oncology Group (ECOG) performance status (PS) > 2
Simultaneous participation in an interventional clinical trial