on-interventional study about safety and efficacy of chemo-therapy with Paclitaxel Stragen(R) / Eurotaxel(R) (new name of the prescription) as mono or combined therapy for routine treatment of ovarial or breast cancer with special consideration of age and BMI starting position.
Recruiting
- Conditions
- Breast cancer, ovarial cancer
- Registration Number
- DRKS00000781
- Lead Sponsor
- apharm GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- 1500
Inclusion Criteria
Histologically secured ovarial or breast cancer.
Signed patient informed consent form.
Exclusion Criteria
Pregnancy.
Other malign diseases in the past 5 years.
Lack of compliance.
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary Outcome is progression free survival (PFS) measured after 3 and 9 months by means of the tumor response (complete remission, partial remission, abjictive stabilisation, objective progression).<br>Overall Survival (OS) is measured after 9 months or by the occurence of a corresponding SAE.
- Secondary Outcome Measures
Name Time Method Influence of age ( <= 65 years versus > 65 years) on therapy, PFS and OS. Influence of BMI ( < 19 kg/ m² versus 19 - 30 kg / m² versus > 30 kg / m² ) on therapy, PFS and OS. The measurements of age, height and weight are performed at therapy start, after 3 and after 9 months. Statistical tests are performed to secure a significant difference between the subgroups. Safety is measured by means of NCI CTCAE citeria by the investigator after 3 and 9 months.