Non-Interventional Study With Vinorelbine ORAL in Advanced Non-Small Cell Lung Carcinoma(NSCLC) and Metastatic Breast Cancer (MBC)

Usage of Vinorelbin ORAL (Navelbine® ORAL) in the Treatment of Advanced Non-small Cell Lung Cancer(NSCLC)and Advanced Breast Cancer

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00890903

Enrollment

Registered

2009-04-30

Start date

2009-03-31

Completion date

2012-04-30

Last updated

2012-07-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metastatic Breast Cancer, Non Small Cell Lung Carcinoma

Keywords

NSCLC, non small cell lung carcinoma, metastatic breast cancer, MBC, advanced breast cancer, Navelbine, Navelbine-ORAL, Vinorelbine, Vinorelbine-ORAL, daily routine, concomitant antiemetic therapy, patient compliance, germany, non-interventional study, oral anti cancer therapy, quality of life

Brief summary

The purpose of this non-interventional study is to collect data on efficacy and toxicity of the use of Navelbine ORAL in daily routine in Germany (especially after availability of an 80mg capsule). The study focusses on concomitant antiemetic therapy and patient compliance.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* At least 18 years old * Male and female patients * Advanced NSCLC (Stage III or IV) or Antracycline-resistant MBC * Therapy with Navelbine capsules in any palliative treatment line * Signed patient informed consent

Exclusion criteria

* Pregnancy and nursing * All other

Design outcomes

Primary

Measure	Time frame
Progression-free-survival	1 year after LPI

Secondary

Measure	Time frame
Therapy performance in the daily routine	1 year after LPI
Time to progression	1 year after LPI
Adverse reactions	1 year after LPI
General condition of patients (requested by a patients' questionnaire)	1 year after LPI
Patient compliance	1 year after LPI
Recording of combinations of applied capsules (requested by a patients' questionnaire)	1 year after LPI
Concomitant antiemetic therapy	1 year after LPI

Countries

Germany

Outcome results