Metastatic Breast Cancer Clinical Trial
Official title:
Extended Dose Frequency 1st-line Therapy of Metastatic Breast Cancer With Paclitaxel and Liposomal Doxorubicin (Myocet®)
Today metastatic breast cancer is regarded as cureless. The treatment is palliative in intent and the goals of treatment include improvement of quality of life and if possible prolongation of life. Treatment in metastatic cancer will usually involve hormone therapy and/or chemotherapy. Weekly application of chemotherapeutical drugs may lead to less drug concentrations in healthy tissue and therefore toxicities maý be reduced.
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
breast cancer.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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