Extended Dose Frequency 1st-line Therapy of Metastatic Breast Cancer With Paclitaxel and Liposomal Doxorubicin (Myocet®)
Breast cancer is the most common malignancy of females. In Germany about 46,000 women come
down with breast cancer yearly.
Present therapies cannot cure the metastatic disease, the main focus is improvement of
quality of life and prolongation of life. It is therefore necessary to test new substances
and/or new combinations and therapy concepts. Among the most active cytotoxic agents used in
advanced breast cancer are the anthracyclines. Since conventional anthracyclines are often
used as adjuvant or neoadjuvant therapy their cardiotoxicity restricts their use in the
therapy of the advanced disease.
Liposomal encapsulated doxorubicin shows better activity than conventional doxorubicin
combined with reduced cardiotoxicity.
Weekly applied cytotoxic agents show a better toxicity profile and hence the cumulative
dosis can be increased. It is expected that the combination of liposomal encapsulated
doxorubicin with paclitaxel given weekly shows improved results in the therapy of metastatic
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
progression free survival assessed by imaging procedures
after 6 weeks, 12 weeks, 18 weeks
Joachim Bischoff, Dr. med.
Klinikum der Otto-von-Guericke Universität Magdeburg, Frauenklinik
Germany: Federal Institute for Drugs and Medical Devices