on-interventional study on the safety and efficacy of an Abraxane(R) mono therapy for the therapy of patients with metasasized breast cancer with special consideration of the toxicity profiles
Recruiting
- Conditions
- C50Malignant neoplasm of breast
- Registration Number
- DRKS00003203
- Lead Sponsor
- OnkoDataMed GmbH !
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- 450
Inclusion Criteria
•Secured metastasized breast cancer with at least 1 metastasis (by means of RECIST or diffuse metastasis of the skeloton)
•Gender: female
•Alge: =18 ýears
•Signed patient informed consent
•Therapy in a practice which is member of the BNGO
•Adequate general condition = 2 on the ECOG Scale
•Adequate bone marrow reserves: number of neutrophiles < 1,5 x 1E9 /L before start of the therapy
Exclusion Criteria
•Pregnancy and lactation
•Lack of compliance
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method •Progression free survival (PFS)<br>•Overall survival (OS)<br>•Safety after 3 months and after 9 months by means of the NCI CTCAE-criteria<br>(National Cancer Institute, Common Terminology for Coding of Adverse Events)
- Secondary Outcome Measures
Name Time Method Questions concerning cost of treatment:<br>•Necessity of the application of GCSF (Granulocyte colony stimulating factor)<br>•Necessary emergency and hospitalizations due to therapy related AE.