Side effects of chemotherapy with Axirubicin-e with a focus on cardiotoxicity and impaired quality of life. C50
Conditions
Interventions
Group 1: Patients with newly diagnosed or secondary localized breast cancer over a total recruitment period of 5 years for whom therapy with axirubicin-e is indicated according to the SmPC. Contraindi
Sponsors
AxioNovo Gmbh
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: - Patients with breast carcinoma for whom therapy with Axirubicin-e® is indicated according to the SmPC. - Age: older than 18 years. - Axirubicin-e® is used in therapy. - A hand-dated and signed consent is available. - The therapy was selected independently of a possible study inclusion.
Exclusion criteria
Exclusion criteria: - Contraindications to the use of Axirubicin-e® according to the technical information. - The patient is participating in another study at the same time. - Pregnancy is present or the patient is breastfeeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Progression during therapy by clinical examination, imaging, or special laboratory at the end of each cycle and during unscheduled visits | — |
Secondary
| Measure | Time frame |
|---|---|
| - Lack of tolerance with a focus on cardiotoxicity. - Lack of tolerance generally raised at the end of each cycle and during unplanned visits. - Pregnancy | — |
Countries
Germany
Contacts
Public ContactBurkard Heckelbacher
Datafaber GbR
Outcome results
None listed