This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

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

This study has been completed.
Information provided by (Responsible Party):
Pierre Fabre Pharma GmbH Identifier:
First received: April 29, 2009
Last updated: June 28, 2012
Last verified: June 2012
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.

Non Small Cell Lung Carcinoma Metastatic Breast Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Usage of Vinorelbin ORAL (Navelbine® ORAL) in the Treatment of Advanced Non-small Cell Lung Cancer(NSCLC)and Advanced Breast Cancer

Resource links provided by NLM:

Further study details as provided by Pierre Fabre Pharma GmbH:

Primary Outcome Measures:
  • Progression-free-survival [ Time Frame: 1 year after LPI ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 62
Study Start Date: March 2009
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Patients with advanced non-small cell lung cancer
Female patients with metastatic, Anthracycline-resistent breast cancer


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with advanced non-small cell lung cancer (NSCLC) or metastatic, Antracycline-resistant breast cancer, treated with Navelbine capsules

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00890903

Pierre Fabre Pharma GmbH
Freiburg, Germany, 79111
Sponsors and Collaborators
Pierre Fabre Pharma GmbH
  More Information

Responsible Party: Pierre Fabre Pharma GmbH Identifier: NCT00890903     History of Changes
Other Study ID Numbers: IOM-155
Study First Received: April 29, 2009
Last Updated: June 28, 2012

Keywords provided by Pierre Fabre Pharma GmbH:
non small cell lung carcinoma
metastatic breast cancer
advanced breast cancer
daily routine
concomitant antiemetic therapy
patient compliance
non-interventional study
oral anti cancer therapy
quality of life

Additional relevant MeSH terms:
Breast Neoplasms
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Neoplasms by Site
Breast Diseases
Skin Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Respiratory Tract Neoplasms
Thoracic Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Antineoplastic Agents, Phytogenic
Antineoplastic Agents processed this record on June 23, 2017