Initial Oral Vinorelbine Dosing Schedules in Clinical Routine in Germany and Austria

• Status: Completed
• Trial end date: 2018-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pierre Fabre Pharma GmbH
• Collaborator: Winicker Norimed GmbH
• Treatments: Vinblastine; Vinorelbine

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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