Status:
TERMINATED
Therapy of Metastatic Breast Cancer With Paclitaxel and Liposomal Doxorubicin
Lead Sponsor:
Claudia Lorenz-Schlüter
Conditions:
Metastatic Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
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. Tr...
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 impr...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT00691912
Start Date
December 1 2006
End Date
December 1 2013
Last Update
September 3 2014
Active Locations (1)
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1
Klinikum der Otto-von Guericke Universität Magdeburg, Frauenklinik
Magdeburg, Saxony-Anhalt, Germany, 39108