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

Pierre Fabre Pharma GmbH62 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Non Small Cell Lung Carcinoma Metastatic Breast Cancer

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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 exclusion criteria listed in SPC (summary of product characteristics) * lack of signed Patient informed consent

Locations (1)

Pierre Fabre Pharma GmbH

Freiburg im Breisgau, Germany

Outcomes

Primary Outcomes

Progression-free-survival

Time frame: 1 year after LPI

Secondary Outcomes

Time to progression

Time frame: 1 year after LPI

Adverse reactions

Time frame: 1 year after LPI

Concomitant antiemetic therapy

Time frame: 1 year after LPI

Patient compliance

Time frame: 1 year after LPI

Recording of combinations of applied capsules (requested by a patients' questionnaire)

Time frame: 1 year after LPI

General condition of patients (requested by a patients' questionnaire)

Time frame: 1 year after LPI

Therapy performance in the daily routine

Time frame: 1 year after LPI

Data from ClinicalTrials.gov

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