Metastatic Breast Cancer
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DRUGliposomal Doxorubicin
20 mg/m² Myocet® as 30-minutes infusion on day 1,8,15 80 mg/m² Paclitaxel as 60-minutes infusion on day 1,8,15 q21d
DRUGMyocet / Paclitaxel
20 mg/m² Myocet® as 30-minutes infusion on day 1,8,15 80 mg/m² Paclitaxel as 60-minutes infusion on day 1,8,15 q21d
Sponsors
Claudia Lorenz-Schlüter
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Women \>/= 18 years with histologically proven metastatic breast cancer * No prior chemotherapy in the advanced situation * ECOG \</= 2 * Adequate bone marrow reserve * left ventricular ejection fraction (LVEF) \>/= 50, measured within 4 weeks before study treatment * Existence of written informed consent
Exclusion criteria
* Previous high dose therapy with stem cell support * Prior adjuvant treatment with cumulative anthracycline dose of 600 mg/m² Epirubicin, 300 mg/m² Doxorubicin, 80 mg/m² Mitoxantrone * Concomitant hormon- or chemotherapy or radiation therapy * Her2/neu overexpression * pregnancy or breast feeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression free survival assessed by imaging procedures | after 6 weeks, 12 weeks, 18 weeks |
Secondary
| Measure | Time frame |
|---|---|
| toxicity, quality of life | every 3 weeks |
| response rate, overall survival | 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. |
Countries
Germany
Outcome results
None listed