Therapy of Metastatic Breast Cancer With Paclitaxel and Liposomal Doxorubicin (MyoPac)
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Extended Dose Frequency 1st-line Therapy of Metastatic Breast Cancer With Paclitaxel and Liposomal Doxorubicin (Myocet®)|
- progression free survival assessed by imaging procedures [ Time Frame: after 6 weeks, 12 weeks, 18 weeks ] [ Designated as safety issue: No ]
- toxicity, quality of life [ Time Frame: every 3 weeks ] [ Designated as safety issue: Yes ]
- response rate, overall survival [ Time Frame: 28 d after last Chemotherapy, up then every 3 months for 1 and a half year, and up then every 6 months until 5 years. ] [ Designated as safety issue: No ]
|Study Start Date:||December 2006|
|Estimated Study Completion Date:||December 2016|
|Estimated Primary Completion Date:||December 2011 (Final data collection date for primary outcome measure)|
Drug: liposomal Doxorubicin
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.
|Contact: Joachim Bischoff, Dr. firstname.lastname@example.org|
|Klinikum der Otto-von Guericke Universität Magdeburg, Frauenklinik||Recruiting|
|Magdeburg, Sachsen-Anhalt, Germany, 39108|
|Principal Investigator:||Joachim Bischoff, Dr. med.||Klinikum der Otto-von-Guericke Universität Magdeburg, Frauenklinik|