Initial Oral Vinorelbine Dosing Schedules in Clinical Routine in Germany and Austria (StepUp)

Pierre Fabre

Status: Completed

Conditions: Breast Cancer; Non-Small-Cell Lung Cancer

Treatments: Drug: Vinorelbine oral

Study type: Observational

Funder types: Industry

Identifiers

NCT02619929

DE2015026

Details and patient eligibility

About

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.

Enrollment: 108 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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