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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00890903
Recruitment Status : Completed
First Posted : April 30, 2009
Last Update Posted : July 2, 2012
Information provided by (Responsible Party):
Pierre Fabre Pharma GmbH

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.

Condition or disease
Non Small Cell Lung Carcinoma Metastatic Breast Cancer

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Study Type : Observational
Actual Enrollment : 62 participants
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
Study Start Date : March 2009
Actual Primary Completion Date : April 2012
Actual Study Completion Date : April 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Patients with advanced non-small cell lung cancer
Female patients with metastatic, Anthracycline-resistent breast cancer

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

Secondary Outcome Measures :
  1. Time to progression [ Time Frame: 1 year after LPI ]
  2. Adverse reactions [ Time Frame: 1 year after LPI ]
  3. Concomitant antiemetic therapy [ Time Frame: 1 year after LPI ]
  4. Patient compliance [ Time Frame: 1 year after LPI ]
  5. Recording of combinations of applied capsules (requested by a patients' questionnaire) [ Time Frame: 1 year after LPI ]
  6. General condition of patients (requested by a patients' questionnaire) [ Time Frame: 1 year after LPI ]
  7. Therapy performance in the daily routine [ Time Frame: 1 year after LPI ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00890903

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Pierre Fabre Pharma GmbH
Freiburg, Germany, 79111
Sponsors and Collaborators
Pierre Fabre Pharma GmbH
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Responsible Party: Pierre Fabre Pharma GmbH Identifier: NCT00890903    
Other Study ID Numbers: IOM-155
First Posted: April 30, 2009    Key Record Dates
Last Update Posted: July 2, 2012
Last Verified: June 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:
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Breast Neoplasms
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms by Site
Breast Diseases
Skin Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms