Breast cancer, ovarial cancer
Conditions
Interventions
Group 1: Observation group: Patients receive chemotherapy with Paclitaxel Stragen(R) / Eurotaxel(R) (new name of the prescription) according to physician's prescription. Parameters of differentiation
Sponsors
Lapharm GmbH
Eligibility
Sex/Gender
Female
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Histologically secured ovarial or breast cancer. Signed patient informed consent form.
Exclusion criteria
Exclusion criteria: Pregnancy. Other malign diseases in the past 5 years. Lack of compliance.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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). Overall Survival (OS) is measured after 9 months or by the occurence of a corresponding SAE. | — |
Secondary
| Measure | Time frame |
|---|---|
| Influence of age ( 65 years) on therapy, PFS and OS. Influence of BMI ( 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. | — |
Countries
Germany
Contacts
Public ContactHeribert Stiegler
OnkoDataMed GmbH
Outcome results
None listed